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97 results on '"MESH: Antirheumatic Agents"'

1. Intravenous versus subcutaneous tocilizumab in Takayasu arteritis: multicentre retrospective study

Author

Mekinian, Arsène, Biard, Lucie, Lorenzo, Dagna, Novikov, Pavel, Salvarani, Carlo, Espitia, Olivier, Sciascia, Savino, Michaud, Martin, Lambert, Marc, Hernández-Rodríguez, José, Schleinitz, Nicolas, Awisat, Abid, Puechal, Xavier, Aouba, Achille, Munoz Pons, Helene, Smitienko, Ilya, Gaultier, Jean Baptiste, Edwige, Le Mouel, Benhamou, Ygal, Perlat, Antoinette, Jego, Patrick, Goulenok, Tiphaine, Sacre, Karim, Lioger, Bertrand, Hassold, Nolan, Broner, Jonathan, Dufrost, Virginie, Sené, Thomas, Seguier, Julie, Maurier, Francois, Berthier, Sabine, Belot, Alexandre, Frikha, Faten, Denis, Guillaume, Audemard-Verger, Alexandra, Koné-Paut, Isabelle, Humbert, Sebastien, Woaye-Hune, Pascal, Tomelleri, Alessandro, Baldissera, Elena Marina, Kuwana, Masataka, Lo Gullo, Alberto, Mukuchyan, Vahan, Dellal, Azeddine, Gaches, Francis, Zeminsky, Pierre, Galli, Elena, Alvarado, Moya, Boiardi, Luigi, Muratore, Francesco, Vautier, Mathieu, Campochiaro, Corrado, Moiseev, Sergey, Vieira, Matheus, Cacoub, Patrice, Fain, Olivier, Saadoun, David, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Lille, Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 (RID-AGE), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), CHU Pitié-Salpêtrière [AP-HP], and The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Subjects
Inflammation, MESH: Antirheumatic Agents, MESH: Humans, MESH: Takayasu Arteritis, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Systemic vasculitis, MESH: Adult, MESH: Retrospective Studies, Autoimmune Diseases, MESH: Treatment Outcome
Abstract

Objectives: In this large multicentre study, we compared the effectiveness and safety of tocilizumab intravenous versus subcutaneous (SC) in 109 Takayasu arteritis (TAK) patients.Methods: We conducted a retrospective multicentre study in referral centres from France, Italy, Spain, Armenia, Israel, Japan, Tunisia and Russia regarding biological-targeted therapies in TAK, since January 2017 to September 2019.Results: A total of 109 TAK patients received at least 3 months tocilizumab therapy and were included in this study. Among them, 91 and 18 patients received intravenous and SC tocilizumab, respectively. A complete response (NIH

Published
2023
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2. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE

Author

Elena Zinovieva, Hélène Herman-Demars, Christophe Hudry, René-Marc Flipo, Cécile Gaujoux-Viala, Salvy-Córdoba, Nathalie, Service de Rhumatologie [CHRU Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département Médical [Paris] (Nordic Pharma SAS), Nordic Pharma SAS [Paris], Service de rhumatologie[Lille], and Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)

Subjects
rheumatoid arthritis, Male, MESH: Antirheumatic Agents, treat-to-target, Physical function, Arthritis, Rheumatoid, Pharmacology (medical), Prospective Studies, Clinical efficacy, skin and connective tissue diseases, Prospective cohort study, AcademicSubjects/MED00360, MESH: Aged, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Clinical Science, Middle Aged, MESH: Methotrexate, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Antirheumatic Agents, Rheumatoid arthritis, Drug Therapy, Combination, Female, optimization, management, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, methotrexate, Disease activity, Rheumatology, Internal medicine, medicine, Humans, Dosing, Aged, MESH: Humans, business.industry, MESH: Adult, medicine.disease, MESH: Male, MESH: Prospective Studies, MESH: Drug Therapy, Combination, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Propensity score matching, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Methotrexate, business, MESH: Female
Abstract

Objectives The STRATEGE (Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis) study aimed to describe treatment strategies in current practice in RA biologic DMARD (bDMARD)-naïve patients with an inadequate response to MTX therapy, and to compare clinical efficacy of the different therapeutic strategies on disease activity after 6 months. Methods The main inclusion criteria of this prospective, observational, multicentre study were confirmed RA diagnosis, treatment by MTX monotherapy and need for therapeutic management modification. Results The 722 patients included had a mean (s.d.) RA duration of 5.3 (6.7) years, a mean DAS28 of 4.0 (1.1); they were all receiving MTX monotherapy, 68% oral, at a mean dose of 15.0 (4.1) mg/week. Two major strategies were identified: (i) MTX monotherapy dose and/or route optimization (72%) and (ii) bDMARD initiation ± MTX (16%). MTX dosing was modified for 70% of patients, maintained (dose and route) for 28% of patients and interrupted for 2%. bDMARDs were started when the MTX mean dose was 17.4 mg/week, 56% parenterally; MTX was maintained concomitantly for 96% of patients. Six-month follow-up results adjusted by propensity score showed that both options were equally successful in improving disease activity and physical function, with 63 and 68% of good-to-moderate EULAR responses, respectively. Conclusion The STRATEGE study shows the importance of initial MTX treatment optimization before initiation of a biological treatment and emphasizes the importance of treat-to-target strategy. Trial registration ClinicalTrials.gov NCT02288520.

Published
2021
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3. Risk of major adverse cardiovascular events in patients initiating biologics/apremilast for psoriatic arthritis: a nationwide cohort study

Author

Philippe Le Corvoisier, Muriel Paul, Laetitia Penso, Laura Pina Vegas, Pascal Claudepierre, Emilie Sbidian, Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Henri Mondor, EPI-PHARE (EPI-PHARE), Caisse nationale d'assurance maladie des travailleurs salariés [CNAMTS]-Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis] (ANSM), Service de dermatologie [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and VO, alexandra

Subjects
MESH: Interleukin-12, medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Biological Products, medicine.medical_treatment, MESH: Interleukin-17, apremilast, Psoriatic arthritis, Rheumatology, Internal medicine, National Health Data System, medicine, Clinical endpoint, MESH: Arthritis, Psoriatic, Pharmacology (medical), In patient, biologics, MESH: Cohort Studies, Survival analysis, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Humans, MESH: Middle Aged, business.industry, MESH: Thalidomide, MESH: Cardiovascular Diseases, MESH: Adult, medicine.disease, MESH: Male, TNF inhibitor, PsA, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Biological Factors, MESH: Tumor Necrosis Factor Inhibitors, Apremilast, business, MESH: Female, Mace, Cohort study, medicine.drug, major adverse cardiovascular event (MACE)
Abstract

Objective Several biological DMARDs (bDMARDs) have demonstrated anti-inflammatory effects in PsA. However, their comparative cardiovascular safety profiles remain unknown. We evaluated the risk of major adverse cardiovascular events (MACEs) in PsA patients on therapy with different classes of bDMARDs and apremilast. Methods This nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. All adults with PsA who were new users of bDMARDs/apremilast (neither in the year before the index date) during 2015–19 were included. Patients with previous cardiovascular diseases were excluded. End of follow-up was 31 December 2019. The primary endpoint was an occurrence of MACEs in a time-to-event analysis with propensity score-weighted Cox and Fine–Gray models. Results Between 2015 and 2019, we included 9510 bDMARD new users [mean age 48.5 (s.d. 12.7) years; 42% men], including 7289 starting a TNF inhibitor, 1058 an IL-12/23 inhibitor and 1163 an IL-17 inhibitor, with 1885 apremilast new users [mean age 54.0 (s.d. 12.5) years; 44% men]. MACEs occurred in 51 (0.4%) patients. After propensity score weighting, the risk of MACEs was significantly greater with IL-12/23 (weighted hazard ratio 2.0, 95% CI 1.3, 3.0) and IL-17 (weighted hazard ratio 1.9, 95% CI 1.2, 3.0) inhibitors than TNF inhibitors, with no significant increased risk with apremilast (weighted hazard ratio 1.3, 95% CI 0.8, 2.2). Similar results were observed with the Fine–Gray competing risks survival model. Conclusion Analysis of a large database revealed a small overall number of MACEs, and the risk of MACEs was greater for PsA new users of IL-12/23 and IL-17 vs TNF inhibitors.

Published
2022
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4. Factors influencing the choice of biologic therapy following Rituximab in patients with rheumatoid arthritis: A retrospective study using propensity score

Author

Gaelle Vial, Anne Tournadre, Adeline Ruyssen-Witrand, Bruno Pereira, Anaïs De Pouilly, Christophe Richez, Claire Daïen, Laetitia Scouppe, Pascale Vergne-Salle, Cédric Lukas, CHU Clermont-Ferrand, Service de Rhumatologie [CHU Limoges], CHU Limoges, Service de Rhumatologie [CHU Pellegrin], Groupe hospitalier Pellegrin, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Hôpital Pierre-Paul Riquet [Toulouse], and CHU Toulouse [Toulouse]

Subjects
Male, MESH: Antirheumatic Agents, medicine.medical_specialty, MESH: Registries, Arthritis, Rheumatoid, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Rheumatology, Internal medicine, medicine, Humans, Registries, 030212 general & internal medicine, Propensity Score, Aged, Retrospective Studies, MESH: Aged, 030203 arthritis & rheumatology, MESH: Arthritis, Rheumatoid, MESH: Humans, business.industry, Abatacept, MESH: Retrospective Studies, Retrospective cohort study, MESH: Propensity Score, medicine.disease, MESH: Male, 3. Good health, Discontinuation, Biological Therapy, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, chemistry, Antirheumatic Agents, Concomitant, Rheumatoid arthritis, Propensity score matching, MESH: Tumor Necrosis Factor Inhibitors, Female, Tumor Necrosis Factor Inhibitors, Rituximab, MESH: Rituximab, MESH: Biological Therapy, business, MESH: Female, medicine.drug
Abstract

Objectives To assess factors influencing the choice and effectiveness of biological disease-modifying antirheumatic drugs (DMARDs) following failure of rituximab (RTX) in rheumatoid arthritis (RA), taking patient profile into account. Methods In a retrospective, multicenter study, data about RA patients starting a new biologic during the year after RTX discontinuation were collected at baseline (when the biologic was introduced after RTX), and during follow-up (3, 6, and 12 months). Characteristics of patients receiving tocilizumab (TCZ), abatacept (ABA), or a TNFα inhibitor (TNFi), EULAR response, and retention rate were compared using multidimensional factorial analysis for patient profiles and multivariate analysis including propensity score built on the patient profile. Results Among 152 patients analyzed (37.5% TCZ, 31.6% ABA, 30.9% TNFi), sex, disease characteristics and activity, concomitant DMARDs or glucocorticoids, and previous use of RTX and TNFi were similar at baseline. Patients receiving ABA were slightly older. Multimorbidity index was higher but not significantly different. Multidimensional factorial analysis showed a distinct profile of patients receiving ABA, characterized by older age, more men, more smokers, more comorbidities, and higher anti-cyclic citrullinated peptide antibody. At 1 year, drug retention was higher for ABA than TNFi after adjustment for disease duration, concomitant DMARDs, glucocorticoids, and propensity score (P = 0.04). Tolerance and serious infections were similar among groups. Conclusions The profile of patients receiving ABA following failure of RTX differed from TNFi and TCZ using multidimensional factorial analysis. After adjustment for propensity score, drug retention rate remained higher with ABA than TNFi.

Published
2020
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5. Deregulation of microRNA expression in monocytes and CD4+ T lymphocytes from patients with axial spondyloarthritis

Author

Fogel, Olivier, Bugge Tinggaard, Andreas, Fagny, Maud, Sigrist, Nelly, Roche, Elodie, Leclere, Laurence, Deleuze, Jean-François, Batteux, Frederic, Dougados, Maxime, Miceli-Richard, Corinne, Tost, Jörg, Institut de Biologie François JACOB (JACOB), Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Descartes - Paris 5 (UPD5), Aarhus University [Aarhus], Hôpital Cochin [AP-HP], Immunorégulation - Immunoregulation, Institut Pasteur [Paris] (IP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), The research described in this manuscript was mainly funded by a Sirius research award (UCB Pharma S.A.). Additional funding was obtained through a Passerelle research award (Pfizer), iCARE (MSD Avenir) and the institutional budget of the CNRGH. O.F. is the recipient of a PhD fellowship from Assistance Publique - Hopitaux de Paris / CEA (poste accueil AP-HP)., and Fagny, Maud

Subjects
MESH: Antirheumatic Agents, lcsh:Diseases of the musculoskeletal system, MESH: Spondylarthritis, [SDV]Life Sciences [q-bio], MESH: Monocytes, Monocytes, MESH: Gene Expression Profiling, MESH: Reverse Transcriptase Polymerase Chain Reaction, Spondyloarthritis, MESH: Cohort Studies, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.BIBS] Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], MESH: Humans, MESH: Middle Aged, CD4 T lymphocytes, MESH: CD4-Positive T-Lymphocytes, MESH: Adult, CD4+ T lymphocytes, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], MESH: Male, [SDV] Life Sciences [q-bio], [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Epigenetics, lcsh:RC925-935, MiRNA, MESH: Spine, MESH: Female, MESH: MicroRNAs, MESH: Cells, Cultured
Abstract

BACKGROUND: MicroRNAs (MiRs) play an important role in the pathogenesis of chronic inflammatory diseases. This study is the first to investigate miR expression profiles in purified CD4+ T lymphocytes and CD14+ monocytes from patients with axial spondyloarthritis (axSpA) using a high-throughput qPCR approach. METHODS: A total of 81 axSpA patients fulfilling the 2009 ASAS classification criteria, and 55 controls were recruited from October 2014 to July 2017. CD14+ monocytes and CD4+ T lymphocytes were isolated from peripheral blood mononuclear cells. MiR expression was investigated by qPCR using the Exiqon Human MiRnome panel I analyzing 372 miRNAs. Differentially expressed miRNAs identified in the discovery cohort were validated in the replication cohort. RESULTS: We found a major difference in miR expression patterns between T lymphocytes and monocytes regardless of the patient or control status. Comparing disease-specific differentially expressed miRs, 13 miRs were found consistently deregulated in CD14+ cells in both cohorts with miR-361-3p, miR-223-3p, miR-484, and miR-16-5p being the most differentially expressed. In CD4+ T cells, 11 miRs were differentially expressed between patients and controls with miR-16-1-3p, miR-28-5p, miR-199a-5p, and miR-126-3p were the most strongly upregulated miRs among patients. These miRs are involved in disease relevant pathways such as inflammation, intestinal permeability or bone formation. Mir-146a-5p levels correlated inversely with the degree of inflammation in axSpA patients. CONCLUSIONS: We demonstrate a consistent deregulation of miRs in both monocytes and CD4+ T cells from axSpA patients, which could contribute to the pathophysiology of the disease with potential interest from a therapeutic perspective. ispartof: Arthritis Res Ther vol:21 issue:1 pages:51- ispartof: location:England status: Published online

Published
2019
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6. Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study

Author

Alain Saraux, Bernard Combe, Francis Fagnani, Gabrielle Cukierman, Isabelle Bru, Jean-Michel Joubert, Jan-Christof Schuller, Jacques Massol, Rene-Marc Flipo, CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), LabEX IGO Immunothérapie Grand Ouest, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Cemka-eval [Bourg La Reine], UCB Pharma, Colombes, UCB Pharma Brussels, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), and Hôpital Roger Salengro [Lille]

Subjects
MESH: Antirheumatic Agents, MESH: Arthritis, Rheumatoid, MESH: Humans, Immunology, MESH: Quality of Life, humanities, MESH: Prospective Studies, Arthritis, Rheumatoid, MESH: France, Treatment Outcome, Rheumatology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Certolizumab Pegol, Quality of Life, Immunology and Allergy, Humans, Tumor Necrosis Factor Inhibitors, MESH: Tumor Necrosis Factor Inhibitors, France, Prospective Studies, MESH: Certolizumab Pegol, MESH: Treatment Outcome
Abstract

International audience; Objectives: To describe the long-term effectiveness and safety of certolizumab pegol in patients with moderate-to-severe rheumatoid arthritis (RA) in a real-world setting in France.Methods: ECLAIR was a 3-year longitudinal, prospective, observational, multicentre study. The primary objective was to describe the EULAR response after 1 year of certolizumab pegol treatment. Other endpoints included DAS28, clinical disease activity index, health assessment questionnaire disability index, fatigue assessment scale, patient's assessment of arthritis pain, patient and physician global assessments of disease activity, patient quality of life, and long-term safety.Results: A total of 792 patients were enrolled, of whom 776 comprised the safety set, and 733 the full analysis set. In the full analysis set, 559, 469 and 430 patients had a 12-, 24- and 36-month visit, respectively. This included 378, 296 and 246 patients still receiving certolizumab pegol at these visits. The percentage of EULAR responders was 75.3% (305/405 patients with an available EULAR response) at 12, 76.5% (261/341) at 24, and 79.6% (226/284) at 36 months. Among those still receiving certolizumab pegol, the percentage of EULAR responders was 81.7% (237/290) at 12, 81.1% (185/228) at 24, and 87.3% (158/181) at 36 months. Sustained improvements were observed in other effectiveness outcomes. Overall, 45.1% (350/776) of patients experienced 776 adverse drug reactions. No new safety signals were identified.Conclusions: This is the first prospective, observational study of an anti-TNF treatment in France. The results confirm the effectiveness and safety profile of certolizumab pegol treatment in patients with RA in a real-world setting.

Published
2021

7. Cardiovascular events and change in cholesterol levels in patients with rheumatoid arthritis treated with tocilizumab: data from the REGATE Registry

Author

Lukas, Cédric, Redondin, Manon, Pane, Isabelle, Soubrier, Martin, Houvenagel, Eric, Sibilia, Jean, Combe, Bernard, Morel, Jacques, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Clermont-Ferrand, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Strasbourg, Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), and Herrada, Anthony

Subjects
[SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Antirheumatic Agents, MESH: Arthritis, Rheumatoid, MESH: Humans, MESH: Registries, Immunology, MESH: Brain Ischemia, Antibodies, Monoclonal, Humanized, MESH: Stroke, Brain Ischemia, Arthritis, Rheumatoid, Stroke, Cholesterol, MESH: Cholesterol, Rheumatology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Immunology and Allergy, Humans, Female, Registries, MESH: Female
Abstract

International audience; Objectives: Rheumatoid arthritis (RA) is responsible for excess mortality mainly due to cardiovascular disease. Studies have found elevated cholesterol levels in RA patients who received tocilizumab (TCZ). We studied the occurrence of major cardiovascular events in RA patients who received TCZ in current practice. We also analysed cholesterol level changes in these patients.Methods: Data were collected from the French REGATE Registry, a multicentre observational study including patients with RA treated with TCZ. All cardiovascular complications were analysed. Changes in cholesterol levels were studied. Factors associated with major adverse cardiac and cerebrovascular events were analysed by multivariate analysis, estimating odds ratios and 95% confidence intervals.Results: During an exposure time of 5591 patient-years (PYs), 35 cardiovascular events occurred in 33 patients, corresponding to an incidence of 0.63/100 PYs. The incidence of ischaemic stroke and cardiac ischaemia was 0.41 and 0.21/100 PYs. Age and personal history of cardiovascular events were identified as risk factors associated with cardiovascular events: OR=1.06 [95% CI 1.02-1.09] and 4.10 [1.90-8.83]. Female sex was a protective factor (OR=0.29 [95% CI 0.14-0.64]). Glucocorticoids may play a role but was not statistically significant. All cholesterol variables were increased in level after the third month of treatment with TCZ, with a 15.4%, 18.9% and 13.4% increase for total cholesterol, LDL-C and HDL-C, at 3 months.Conclusions: In current practice, cardiovascular events occurring under TCZ treatment is in the range of what is expected in RA patients despite a global increase in cholesterol levels.

Published
2021

8. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort

Author

Marina Backhaus, Ori Elkayam, J. Carter Thorne, Gianfranco Ferraccioli, Paul P. Tak, Mikkel Østergaard, M. Govoni, Joanne Homik, Clifton O. Bingham, Walter P. Maksymowych, Hilde Berner Hammer, Dirkjan van Schaardenburg, Alexandre Sepriano, Maxime Dougados, Joel Paschke, Désirée van der Heijde, Sofia Ramiro, Robert Landewé, Alain Cantagrel, Alain Saraux, Cheryl Barnabe, Oliver FitzGerald, Maggie Larché, Luigi Sinigaglia, E. Hutchings, Maurizio Rossini, Thierry Schaeverbeke, Gerd R Burmester, Bernard Combe, Gilles Boire, R. Dadashova, Leiden University Medical Center (LUMC), Zuyderland Hospital [Heerlen, The Netherlands], St Vincent's University Hospital, Rigshospitalet [Copenhagen], Copenhagen University Hospital, University of Alberta, Tel Aviv Sourasky Medical Center [Te Aviv], The Arthritis Program Research Group, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Université de Sherbrooke (UdeS), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, CHU de Bordeaux Pellegrin [Bordeaux], Centre National de Référence CERAINO, Service de Rhumatologie (Hôpital de la Cavale Blanche), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Università degli studi di Verona = University of Verona (UNIVR), Università degli Studi di Ferrara = University of Ferrara (UniFE), Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), University of Calgary, Johns Hopkins University School of Medicine [Baltimore], VU University Medical Center [Amsterdam], Diakonhjemmet Hospital, CaRE Arthritis Ltd, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Salvy-Córdoba, Nathalie, Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Università degli Studi di Ferrara (UniFE), Hôpital Pierre-Paul Riquet [Toulouse], CHU Toulouse [Toulouse], Clinical Immunology and Rheumatology, and AII - Inflammatory diseases

Subjects
0301 basic medicine, medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Remission Induction, MESH: Rheumatoid Factor, Immunology, Best Treatment Practices, Rheumatoid Arthritis, Severity of Illness Index, Longitudinal model, Gee, NO, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Rheumatoid Factor, Internal medicine, MESH: Severity of Illness Index, medicine, Humans, Immunology and Allergy, Generalized estimating equation, MESH: Treatment Outcome, 030203 arthritis & rheumatology, MESH: Arthritis, Rheumatoid, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Humans, business.industry, Remission Induction, Protocol Requirement, Baseline model, Treat to target, rheumatoid arthritis, T2T. rheumatology, medicine.disease, T2T. rheumatology, Treatment Outcome, 030104 developmental biology, Rheumatoid Arthritis, Best Treatment Practices, Treat-to-target, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rheumatoid arthritis, Cohort, Tumor Necrosis Factor Inhibitors, Treat-to-Target, MESH: Tumor Necrosis Factor Inhibitors, business
Abstract

Objective.Compelling evidence supports a treat-to-target (T2T) strategy for optimal outcomes in rheumatoid arthritis (RA). There is limited knowledge regarding the factors that impede implementation of T2T, particularly in a setting where adherence to T2T is protocol-specified. We aimed to assess clinical factors that associate with failure to adhere to T2T.Methods.Patients with RA from 10 countries who were starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required per protocol to adhere to the T2T strategy. Factors influencing adherence to T2T low disease activity (T2T-LDA; 44-joint count Disease Activity Score ≤ 2.4) were analyzed in 2 types of binomial generalized estimating equations models: (1) including only baseline features (baseline model); and (2) modeling variables that inherently vary over time as such (longitudinal model).Results.A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. Failure of adherence to T2T-LDA was noted in 1765 visits (40.5%). In the baseline multivariable model, a high number of comorbidities (OR 1.10, 95% CI 1.02–1.19), smoking (OR 1.32, 95% CI 1.08–1.63) and high number of tender joints (OR 1.03, 95% CI 1.02–1.04) were independently associated with failure to implement T2T, while anticitrullinated protein antibody/rheumatoid factor positivity (OR 0.63, 95% CI 0.50–0.80) was a significant facilitator of T2T. Results were similar in the longitudinal model.Conclusion.Lack of adherence to T2T in the RA BIODAM cohort was evident in a substantial proportion despite being a protocol requirement, and this could be predicted by clinical features. [Rheumatoid Arthritis (RA) BIODAM cohort; ClinicalTrials.gov: NCT01476956].

Published
2020
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9. Safety of surgery in patients with rheumatoid arthritis treated with tocilizumab: data from the French (REGistry -RoAcTEmra) Regate registry

Author

Morel, Jacques, Locci, Marie, Banal, Frédéric, Combe, Bernard, Cormier, Grégoire, Dougados, Maxime, Flipo, René-Marc, Marcelli, Christian, Pham, Thao, Rist, Stéphanie, Solau Gervais, Elizabeth, Sibilia, Jean, Lukas, Cédric, Service de Rhumatologie [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital d'Instruction des Armées Legouest, Service de Santé des Armées, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Roger Salengro [Lille], Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Rhumatologie [CHU Sainte Marguerite], Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Centre Hospitalier Régional d'Orléans (CHRO), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hôpital de Hautepierre [Strasbourg], and Salvy-Córdoba, Nathalie

Subjects
[SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Antirheumatic Agents, MESH: Arthritis, Rheumatoid, MESH: Humans, [SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery, MESH: Registries, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Antibodies, Monoclonal, Humanized, MESH: Surgical Procedures, Operative, Arthritis, Rheumatoid, Postoperative Complications, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Surgical Procedures, Operative, MESH: Postoperative Complications, Humans, Surgical Wound Infection, Female, Registries, MESH: Rituximab, Rituximab, MESH: Surgical Wound Infection, MESH: Female
Abstract

International audience; To investigate the frequency and risk factors of postoperative complications in RA patients treated with tocilizumab (TCZ).METHODS: the French registry REGATE recruited 1496 RA patients receiving TCZ in routine care. Data from patients treated with TCZ who underwent surgery were reviewed. Frequency of post-surgery complications was collected and compared in patients with and without complications in order to identify factors associated with complications. Similar analysis was performed in patients with postoperative infection.RESULTS: we identified 167 patients who underwent 175 surgical procedures including 103 orthopaedic surgeries (58.9%). The patients were mainly women (84%) with a mean disease duration of 14.96±11.29 years. The mean delay between surgery and the last TCZ infusion was 4.94±1.74 weeks. Fifteen patients experienced 15 complications (8.6%) with 10 severe infections including 5 surgical site infections (33.3%). There was no significant difference between patients with and without complications. In multivariate analysis, previous treatment with rituximab in the previous year tended to be associated with postoperative complications (OR: 3.27, IC95% 0.92–11.49, p=0.06). Concerning postoperative infections, diabetes mellitus tended to be associated with this complication (OR: 3.73, IC95% 0.88–15.79, p=0.06) in multivariate analysis.CONCLUSIONS: in RA patients treated with TCZ in perfusion, the rate of surgical complications was low: 8.6%. The median time between surgery and last infusion was relatively short according to half-life of TCZ but did not influence the rate of postoperative complications.

Published
2020

10. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis

Author

Safa Aouinti, Nathalie Filippi, Verushka Valsecchi, Christian Jorgensen, Gregoire Mercier, Hind Letaief, Pierre Le Blay, Sarah Marouen, Rosanna Ferreira, Michel Autuori, Thibault Mura, Dominique Fournet, Yves-Marie Pers, Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)

Subjects
Male, MESH: Antirheumatic Agents, Quality management, Health Status, Telehealth, smartphone, law.invention, Arthritis, Rheumatoid, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Pharmacology (medical), 030212 general & internal medicine, MESH: Health Status, MESH: Aged, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Disease Management, Middle Aged, Telemedicine, 3. Good health, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Young Adult, Rheumatoid arthritis, Antirheumatic Agents, Female, Adult, medicine.medical_specialty, Adolescent, MESH: Disease Management, 03 medical and health sciences, Young Adult, Rheumatology, medicine, Humans, In patient, Aged, MESH: Adolescent, 030203 arthritis & rheumatology, MESH: Humans, business.industry, MESH: Quality of Life, MESH: Adult, medicine.disease, MESH: Male, Clinical trial, monitoring, randomized controlled trial, MESH: Telemedicine, Physical therapy, Quality of Life, business, RA, MESH: Female
Abstract

Objectives In RA, telemedicine may allow tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician’s interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA. Methods A six-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new DMARD therapy. Two groups were established: ‘connected monitoring’ and ‘conventional monitoring’. The primary outcome was the number of physical visits between baseline and six months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12). Results Of the 94 randomized patients, 89 completed study: 44 in the ‘conventional monitoring’ arm and 45 in the ‘connected monitoring’ arm. The total number of physical visits between required baseline and six-month visits was significantly lower in the ‘connected monitoring’ group [0.42 (0.58) vs 1.93 (0.55); P Conclusion Our results suggest that connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03005925.

Published
2020
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11. Stability of infliximab solutions in different temperature and dilution conditions

Author

Yoann Le Basle, Valérie Sautou, Philip Chennell, Nicolas Tokhadzé, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), and CHU Clermont-Ferrand

Subjects
MESH: Antirheumatic Agents, Time Factors, Clinical Biochemistry, Ion chromatography, MESH: Infliximab, Pharmaceutical Science, MESH: Peptide Mapping, 030226 pharmacology & pharmacy, Analytical Chemistry, MESH: Osmolar Concentration, 0302 clinical medicine, Drug Stability, MESH: Spectrophotometry, Ultraviolet, Spectroscopy, Fourier Transform Infrared, Drug Discovery, MESH: Nephelometry and Turbidimetry, Spectroscopy, MESH: Technology, Pharmaceutical, Protein Stability, Chemistry, Temperature, MESH: Chromatography, Gel, Chromatography, Ion Exchange, MESH: Temperature, 3. Good health, Dilution, Pharmaceutical Solutions, Antirheumatic Agents, 030220 oncology & carcinogenesis, Chromatography, Gel, Stability, MESH: Pharmaceutical Solutions, medicine.drug, Monoclonal antibody, MESH: Biosimilar Pharmaceuticals, medicine.drug_class, Drug Compounding, Size-exclusion chromatography, Peptide Mapping, Stability (probability), MESH: Spectroscopy, Fourier Transform Infrared, Protein Aggregates, 03 medical and health sciences, Dynamic light scattering, Nephelometry and Turbidimetry, MESH: Drug Stability, MESH: Protein Stability, medicine, Technology, Pharmaceutical, Biosimilar Pharmaceuticals, Chromatography, Osmolar Concentration, MESH: Time Factors, Analytical, MESH: Chromatography, Ion Exchange, Infliximab, MESH: Protein Aggregates, Chemical instability, MESH: Drug Compounding, Nanoparticles, Chemistry techniques, Spectrophotometry, Ultraviolet, MESH: Nanoparticles, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Infliximab is a monoclonal antibody widely used for the treatment of inflammatory diseases. Over the past few years, many studies have assessed that monoclonal antibodies are prone to aggregation under stress conditions. The aim of this study was to investigate the stability of solutions of an infliximab biosimilar (Inflectra®) at different concentrations (0.4, 2 and 10 mg/mL). These solutions were separately submitted to three temperature conditions that are likely to happen during the drug dispensing system: −20 °C, 5 °C and 25 °C. To perform a complete characterization of infliximab physicochemical and structural stability, a wide range of analytical techniques was employed including: visual inspection, subvisible particles counting (HIAC), dynamic light scattering (DLS), size exclusion chromatography (SEC), cation exchange chromatography (CEX), and analysis of primary, secondary and tertiary structure. When stored at 25 °C, chemical instability was the main limiting factor (highlighted by CEX), while SEC showed only some acceptable variations. After a single freeze-thawing cycle, the amount of subvisible particles was significantly increased. Some variations were also visible in CEX and the hydrodynamic diameter was increased after thawing 10 mg/mL samples. In regard of these results, infliximab (Inflectra®) solutions should not be used after a single freeze-thawing cycle between reconstitution and administration to the patient. The results showed stability at 5 °C of up to 14 days for 10 mg/mL solutions and 90 days for 0.4 and 2 mg/mL solutions, whilst samples stored at 25 °C were stable only 7 days at 10 mg/mL and 30 days when diluted.

Published
2018
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12. Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study

Author

Jean-Michel Joubert, Alain Saraux, Francis Fagnani, René-Marc Flipo, G. Cukierman, Philippe Huot-Marchand, Jacques Massol, Bernard Combe, Salvy-Córdoba, Nathalie, Service de Rhumatologie [CHU de la Cavale-Blanche], Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), CHU Lille, Cemka-eval [Bourg La Reine], Institut Phisquare, Fondation Transplantation, Centre d'Investigation Clinique de Besançon (Inserm CIC 1431), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), UCB Pharma, Colombes, ICON plc [Lyon], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])

Subjects
Male, MESH: Antirheumatic Agents, Time Factors, MESH: Treatment Failure, lcsh:Medicine, DMARDs (biologic), Severity of Illness Index, Arthritis, Rheumatoid, Anti-TNF, 0302 clinical medicine, Immunology and Allergy, Prospective Studies, Treatment Failure, 030212 general & internal medicine, Disease activity, Certolizumab pegol, MESH: Aged, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, medicine.diagnostic_test, Middle Aged, MESH: Predictive Value of Tests, 3. Good health, MESH: Methotrexate, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Erythrocyte sedimentation rate, Rheumatoid arthritis, Drug Therapy, Combination, Female, France, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, MESH: Certolizumab Pegol, medicine.drug, Adult, medicine.medical_specialty, Immunology, Blood Sedimentation, 03 medical and health sciences, Rheumatology, Disease severity, Predictive Value of Tests, Internal medicine, MESH: Severity of Illness Index, medicine, Humans, In patient, Glucocorticoids, MESH: Blood Sedimentation, Aged, 030203 arthritis & rheumatology, MESH: Humans, business.industry, lcsh:R, MESH: Time Factors, MESH: Adult, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, Clinical disease, medicine.disease, MESH: Male, MESH: Prospective Studies, MESH: France, MESH: Drug Therapy, Combination, Methotrexate, Certolizumab Pegol, Observational study, business, MESH: Glucocorticoids, MESH: Female
Abstract

ObjectiveTo evaluate the performance of clinical criteria for predicting late treatment failure in patients with early non-response to certolizumab pegol (CZP).MethodsA protocol-specified analysis of interim data from ECLAIR, a 3-year longitudinal, prospective, observational, multicentre study of patients with active rheumatoid arthritis (RA) initiating CZP treatment in France, was conducted. Clinical measures assessed were Clinical Disease Activity Index (CDAI), Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28(ESR)) and Health Assessment Questionnaire Disability Index (HAQ-DI). Early non-response was measured at 3 months (M3) and failure to achieve low disease activity (LDA) at 12 months (M12).Results574/792 enrolled patients were treated at M3. The numbers available for predictability analyses were 532 (CDAI), 434 (DAS28(ESR)) and 496 (HAQ-DI). Of the three indices evaluated, the highest predictor of non-response value was observed for the CDAI (88.8% (95% CI 81.0 to 94.1)), indicating that up to 88% of patients identified as non-responders at M3 failed to achieve LDA at M12, regardless of baseline disease severity or treatment history. The specificity for this measure was also very high (96.0%), indicating that less than 5% of patients who achieved CDAI response at M12 had not responded at M3. Similar predictability was observed for DAS28(ESR), but only in patients with high disease activity at baseline and/or those previously treated by a biological disease-modifying antirheumatic drug.ConclusionCDAI non-response at M3 is a predictor of failure to achieve the therapeutic target of LDA at M12 in patients with RA initiating treatment with CZP.

Published
2020
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13. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis

Author

Hideto Kameda, Bernard Combe, Mark C. Genovese, Wen Xu, Juan D. Cañete, Gaia Gallo, Proton Rahman, Noah Agada, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Memorial University of Newfoundland [St. John's], Toho University Omori Medical Center [Tokyo], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Eli Lilly and Company [Indianapolis], and Stanford University

Subjects
Adult, Male, medicine.medical_specialty, MESH: Antirheumatic Agents, lcsh:Diseases of the musculoskeletal system, Ixekizumab, Population, Antibodies, Monoclonal, Humanized, Inflammatory bowel disease, 030207 dermatology & venereal diseases, 03 medical and health sciences, Psoriatic arthritis, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, MESH: Arthritis, Psoriatic, Humans, MESH: Double-Blind Method, Adverse effect, education, 030203 arthritis & rheumatology, education.field_of_study, MESH: Humans, MESH: Middle Aged, business.industry, Arthritis, Psoriatic, MESH: Adult, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, Middle Aged, medicine.disease, Rheumatology, MESH: Male, 3. Good health, Clinical trial, Upper respiratory tract infection, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Antibodies, Monoclonal, Humanized, Major adverse cardiovascular events, Antirheumatic Agents, Female, lcsh:RC925-935, Safety, business, MESH: Female, Research Article
Abstract

Background The long-term safety was assessed in patients with psoriatic arthritis who were treated with ixekizumab in three clinical trials (SPIRIT-P1/-P2/-P3). Methods Integrated safety data from three trials (controlled and uncontrolled), including two pivotal phase 3, randomized, double-blind clinical trials: SPIRIT-P1 and SPIRIT-P2, were assessed. Safety data were integrated from the all ixekizumab exposure safety population (defined as all patients receiving ≥ 1 dose of ixekizumab). We report exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) at 1-year intervals up to 3 years for adverse events. Results Total exposure to IXE reached 1822.2 PY (1118 patients). The IRs/100 PY for the following treatment discontinuations were as follows: adverse events (5.3); serious infections (1.3); injection-site reactions (12.7); infections (34.2); and deaths (0.3). The IRs for treatment-emergent adverse events decreased or remained stable over time, the most common being upper respiratory tract infection, nasopharyngitis, and injection-site reactions. The IRs for serious adverse events and serious infections remained stable over time, whereas for injection-site reactions and general infections, IRs decreased with longer ixekizumab exposure. Opportunistic infections were limited to oral and esophageal candida and localized herpes zoster. No suicide or self-injury-related behaviors were reported. The IRs/100 PY for safety topics of special interest included inflammatory bowel disease (adjudicated; 0.1), depression (1.6), malignancies (0.7), and major adverse cardiovascular events (0.6). Conclusions The findings of this integrated safety analysis in patients with psoriatic arthritis are consistent with the known safety profile of ixekizumab. No unexpected safety signals were observed with ixekizumab treatment in patients with psoriatic arthritis. Trial registration SPIRIT-P1 (NCT01695239; Registered August 08, 2012), SPIRIT-P2 (NCT02349295; September 23, 2014), and SPIRIT-P3 (NCT02584855; August 04, 2015).

Published
2020
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14. Does methotrexate improve TNF inhibitor drug survival in elderly patients with RA?

Author

Martin Soubrier, Clément Lahaye, Unité de Nutrition Humaine (UNH), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Clermont-Ferrand, Service de Rhumatologie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Clermont-Ferrand

Subjects
musculoskeletal diseases, Oncology, medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Biological Products, medicine.medical_treatment, Population, MEDLINE, Arthritis, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Internal medicine, MESH: Rheumatology, medicine, skin and connective tissue diseases, education, 030304 developmental biology, 030203 arthritis & rheumatology, MESH: Aged, 0303 health sciences, education.field_of_study, MESH: Arthritis, Rheumatoid, MESH: Humans, business.industry, medicine.disease, 3. Good health, TNF inhibitor, Drug survival, MESH: Methotrexate, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Methotrexate, business, medicine.drug
Abstract

Methotrexate is commonly used in combination with biologic DMARDs in the treatment of rheumatoid arthritis on the basis that the combined therapy has synergistic benefits. New data challenge this concept in the treatment of older adults and highlight the uncertainty of the mode of action of methotrexate in this population.

Published
2020
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15. Is treat-to-target really working in rheumatoid arthritis? a longitudinal analysis of a cohort of patients treated in daily practice (RA BIODAM)

Author

Joel Paschke, Sofia Ramiro, E. Hutchings, Cheryl Barnabe, Dirkjan van Schaardenburg, Thierry Schaeverbeke, Alexandre Sepriano, Désirée van der Heijde, Bernard Combe, Robert Landewé, Marina Backhaus, Maurizio Rossini, Margaret Larche, Joanne Homik, Marcello Govoni, Walter P. Maksymowych, Cornelia F Allaart, Ori Elkayam, Clifton O. Bingham, Alain Saraux, J. Carter Thorne, Oliver FitzGerald, Luigi Sinigaglia, Gilles Boire, Hilde Berner Hammer, R. Dadashova, Gianfranco Ferraciolli, Paul P. Tak, Maxime Dougados, Alain Cantagrel, Mikkel Østergaard, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, Ramiro, Sofia [0000-0002-8899-9087], van der Heijde, Désirée [0000-0002-5781-158X], Sepriano, Alexandre [0000-0003-1954-0229], Boire, Gilles [0000-0003-2481-5821], Saraux, Alain [0000-0002-8454-7067], Rossini, Maurizio [0000-0001-9692-2293], Bingham, Clifton O [0000-0002-4752-5029], Tak, Paul P [0000-0002-3532-5409], Maksymowych, Walter P [0000-0002-1291-1755], Apollo - University of Cambridge Repository, Leiden University Medical Center (LUMC), Zuyderland Hospital [Heerlen, The Netherlands], Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), NOVA Medical School - Faculdade de Ciências Médicas (NMS), Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), St Vincent's University Hospital, Copenhagen Center for Arthritis Research,Copenhagen (Center for Rheumatology and Spine Diseases), Rigshospitalet [Copenhagen], Copenhagen University Hospital, University of Alberta, Tel Aviv Sourasky Medical Center [Te Aviv], University of Toronto, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Roma] (Unicatt), Park-Klinik Weissensee, CIUSSS de l'Estrie - CHUS, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Aquitaine’s Care and Research organisation for inflammatory and Immune-Mediated diseases [CHU Bordeaux] (FHU ACRONIM), CHU Bordeaux [Bordeaux], CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Azienda Ospedaliero-Universitaria Sant'Anna Hospital of Ferrara, Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, University of Calgary, Johns Hopkins University School of Medicine [Baltimore], Ghent University Hospital, Cambridge University Hospitals - NHS (CUH), University of Cambridge [UK] (CAM), Diakonhjemmet Hospital, and CaRE Arthritis Ltd

Subjects
Male, rheumatoid arthritis, MESH: Remission Induction, MESH: Antirheumatic Agents, treat-to-target, Patient Care Planning, Arthritis, Rheumatoid, Cohort Studies, remission, 0302 clinical medicine, Daily practice, Rheumatoid, Immunology and Allergy, Medicine, 030212 general & internal medicine, Longitudinal Studies, MESH: Longitudinal Studies, MESH: Cohort Studies, MESH: Aged, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, MESH: Clinical Decision-Making, Remission Induction, Middle Aged, 3. Good health, Clinical Practice, C-Reactive Protein, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Antirheumatic Agents, Cohort, Joint damage, MESH: Tumor Necrosis Factor Inhibitors, Female, Adult, medicine.medical_specialty, MESH: Rheumatoid Factor, Immunology, Clinical Decision-Making, Blood Sedimentation, General Biochemistry, Genetics and Molecular Biology, NO, Disease activity, 03 medical and health sciences, Rheumatology, Rheumatoid Factor, Internal medicine, MESH: Patient Care Planning, MESH: C-Reactive Protein, Humans, In patient, MESH: Blood Sedimentation, Aged, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Tumor Necrosis Factor Inhibitors, Arthritis, MESH: Adult, Treat to target, medicine.disease, MESH: Male, business, MESH: Female
Abstract

ObjectivesTo investigate whether following a treat-to-target (T2T)-strategy in daily clinical practice leads to more patients with rheumatoid arthritis (RA) meeting the remission target.MethodsRA patients from 10 countries starting/changing conventional synthetic or biological disease-modifying anti-rheumatic drugs were assessed for disease activity every 3 months for 2 years (RA BIODAM (BIOmarkers of joint DAMage) cohort). Per visit was decided whether a patient was treated according to a T2T-strategy with 44-joint disease activity score (DAS44) remission (DAS44 ResultsIn total 4356 visits of 571 patients (mean (SD) age: 56 (13) years, 78% female) were included. Appropriate application of T2T was found in 59% of the visits. T2T (vs no T2T) did not yield a higher likelihood of DAS44 remission 3 months later (OR (95% CI): 1.03 (0.92 to 1.16)), but sustained T2T resulted in an increased likelihood of achieving DAS44 remission (OR: 1.19 (1.03 to 1.39)). Similar results were seen with DAS28-ESR remission. For more stringent definitions (CDAI, SDAI and ACR/EULAR Boolean remission), T2T was consistently positively associated with remission (OR range: 1.16 to 1.29), and sustained T2T had a more pronounced effect on remission (OR range: 1.49 to 1.52).ConclusionIn daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher rates of remission.

Published
2020
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16. Outcomes and findings of the international rheumatoid arthritis (RA) BIODAM cohort for validation of soluble biomarkers in RA

Author

Hilde Berner Hammer, G. Boire, Ori Elkayam, Bernard Combe, Joel Paschke, Sofia Ramiro, Joanne Homik, Walter P. Maksymowych, E. Hutchings, Maxime Dougados, Marina Backhaus, Maurizio Rossini, Alain Cantagrel, Désirée van der Heijde, Paul P. Tak, Cheryl Barnabe, Gianfranco Ferraccioli, Maggie Larché, Alexandre Sepriano, J. Carter Thorne, Dirkjan van Schaardenburg, M. Govoni, Thierry Schaeverbeke, Robert G. W. Lambert, Luigi Sinigaglia, Clifton O. Bingham, R. Dadashova, Mikkel Østergaard, Alain Saraux, Oliver FitzGerald, Gerd R Burmester, Robert Landewé, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, University of Alberta, CaRE Arthritis Ltd, St Vincent's University Hospital, Copenhagen Center for Arthritis Research,Copenhagen (Center for Rheumatology and Spine Diseases), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Leiden University Medical Center (LUMC), Tel Aviv Sourasky Medical Center [Te Aviv], Zuyderland Hospital [Heerlen, The Netherlands], University of Toronto, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Université de Sherbrooke (UdeS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU de Bordeaux Pellegrin [Bordeaux], CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Azienda Ospedaliero-Universitaria Sant'Anna Hospital of Ferrara, Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Hôpital Pierre-Paul Riquet [Toulouse], CHU Toulouse [Toulouse], University of Calgary, Johns Hopkins University School of Medicine [Baltimore], VU University Medical Center [Amsterdam], Vrije Universiteit Amsterdam [Amsterdam] (VU), Diakonhjemmet Hospital, and University of Amsterdam [Amsterdam] (UvA)

Subjects
0301 basic medicine, BIOMARKER, MESH: Antirheumatic Agents, PROGNOSIS, Radiography, Severity of Illness Index, Arthritis, Rheumatoid, 0302 clinical medicine, Clinical endpoint, Immunology and Allergy, Prospective Studies, Prospective cohort study, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, OMERACT, risk assessment, Middle Aged, 3. Good health, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Antirheumatic Agents, Cohort, Disease Progression, Biomarker (medicine), MESH: Disease Progression, Female, medicine.medical_specialty, Soluble Biomarkers, Rheumatoid Arthritis, radiographic progression, risk assessment, OMERACT, rheumatoid arthritis, BIODAM, Immunology, Soluble Biomarkers, Rheumatoid Arthritis, NO, 03 medical and health sciences, Rheumatology, Internal medicine, MESH: Severity of Illness Index, medicine, Rheumatoid factor, Humans, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Mean age, medicine.disease, MESH: Prospective Studies, BIODAM, 030104 developmental biology, radiographic progression, MESH: Biomarkers, business, MESH: Female, Biomarkers
Abstract

Objective.The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.Methods.Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.Results.A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor–positive or anticitrullinated protein antibody–positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.Conclusion.The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956)

Published
2020
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17. Glucocorticoids in rheumatoid arthritis: current status and future studies

Author

C. Hua, Bernard Combe, Frank Buttgereit, Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Institut de Génétique Moléculaire de Montpellier (IGMM), and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)

Subjects
MESH: Antirheumatic Agents, Future studies, lcsh:Medicine, corticosteroids, Arthritis, Rheumatoid, 0302 clinical medicine, MESH: Practice Guidelines as Topic, Daily practice, Immunology and Allergy, 030212 general & internal medicine, MESH: Treatment Outcome, Randomized Controlled Trials as Topic, MESH: Arthritis, Rheumatoid, Evidence-Based Medicine, treatment, 3. Good health, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Antirheumatic Agents, Practice Guidelines as Topic, Drug Therapy, Combination, Early arthritis, medicine.medical_specialty, Immunology, Rheumatoid Arthritis, MESH: Drug Administration Schedule, Drug Administration Schedule, 03 medical and health sciences, Rheumatology, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Internal medicine, medicine, Humans, Intensive care medicine, Glucocorticoids, 030203 arthritis & rheumatology, MESH: Humans, business.industry, lcsh:R, medicine.disease, MESH: Drug Therapy, Combination, MESH: Randomized Controlled Trials as Topic, Relative risk, Antirheumatic drugs, business, MESH: Glucocorticoids, Rheumatism, MESH: Evidence-Based Medicine
Abstract

International audience; Since their first use for treating rheumatoid arthritis (RA) in the late 1940s, glucocorticoids (GCs) have been representing a substantial part of the therapeutic arsenal for RA. However, even if GCs are still widely prescribed drugs, their toxicity is discussed controversially, so obtaining consensus on their use in RA is difficult. Hence, the most recent European League Against Rheumatism and American College of Rheumatology recommendations on early arthritis and RA management advocate the use of GCs as adjunct treatment to conventional synthetic disease-modifying antirheumatic drugs, at the lowest dose possible and for the shortest time possible. However, the recommendations remain relatively vague on dose regimens and routes of administration. Here, we describe literature data on which the current recommendations are based as well as data from recent trials published since the drafting of the guidelines. Moreover, we make proposals for daily practice and provide suggestions for studies that could help clarifying the place of GCs in RA management. Indeed, numerous items, including the benefit/risk ratio of low-dose and very low-dose GCs and optimal duration of GCs as bridging therapy, remain on the research agenda, and future studies are needed to guide the next recommendations for RA.

Published
2020
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18. Clinical and Structural Efficacy of Hydroxychloroquine in Rheumatoid Arthritis: A Systematic Review

Author

C. Hua, Cédric Lukas, Thomas Barnetche, Cécile Gaujoux-Viala, Jacques Morel, Bernard Combe, Claire Rempenault, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Bordeaux [Bordeaux], and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)

Subjects
medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Hydroxychloroquine, Arthritis, Cochrane Library, Placebo, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Sulfasalazine, Internal medicine, medicine, Humans, MESH: Treatment Outcome, 030203 arthritis & rheumatology, MESH: Arthritis, Rheumatoid, MESH: Humans, business.industry, Hydroxychloroquine, medicine.disease, 3. Good health, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rheumatoid arthritis, business, Rheumatism, medicine.drug
Abstract

International audience; Hydroxychloroquine (HCQ) improves metabolic and cardiovascular outcomes in patients with rheumatoid arthritis (RA), but its efficacy appears to be moderate as compared to placebo. The aim of our study was to assess the current literature on the clinical and structural efficacy of HCQ in the joints of patients with RA.Methods: We systematically searched MEDLINE (via PubMed), Embase, Cochrane Library, and the American College of Rheumatology and European League Against Rheumatism annual scientific meeting abstracts for studies available up to November 2017 comparing the efficacy of HCQ in patients with RA, in monotherapy or combined with other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Data were extracted by 1 investigator and independently checked by a different investigator.Results: The literature search revealed 197 articles and abstracts of potential interest, and 11 studies fulfilled inclusion criteria. The clinical and structural efficacy of HCQ was similar to or lower than that for methotrexate or sulfasalazine in monotherapy. HCQ combined with other DMARDs could increase the clinical efficacy.Conclusion: In addition to its metabolic benefit, combining HCQ with other DMARDs could provide some clinical improvement in patients with RA and inadequate response to previous csDMARDs.

Published
2019
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19. EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies

Author

Ramos-Casals, M., Brito-Zeron, P., Bombardieri, S., Bootsma, H., De Vita, S., Dorner, T., Fisher, B. A., Gottenberg, J. -E., Hernandez-Molina, G., Kocher, A., Kostov, B., Kruize, A. A., Mandl, T., W. -F., Ng, Retamozo, S., Seror, R., Shoenfeld, Y., Siso-Almirall, A., Tzioufas, A. G., Vitali, C., Bowman, S., EULAR-Sjögren Syndrome Task Force Group: Sebastian A, Mariette X., Saraux, A, Vissink, A, Rasmussen, A, Hofauer, B, Armagan, B, Feijoo-Massó, C, Shiboski, Ch, Baldini, C, Vollenweider, C, Sene, D, Hammenfors, D, Isenberg, D, Danda, D, Bartoloni, E, Hospital Clinic i Provincial de Barcelona (SCReN), CELLEX-IDIBAPS Department of Autoimmune Diseases, Barcelona, H. CIMA-Sanitas, Barcelona, University of Pisa - Università di Pisa, University of Groningen [Groningen], Ospedale 'Santa Maria della Misericordia' = University Hospital 'Santa Maria della Misericordia', Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], University of Birmingham [Birmingham], Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Immunopathologie et chimie thérapeutique (ICT), Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - National Institute of Medical Science and Nutrition Salvador Zubiran [Mexico], University Hospital Basel [Basel], Bern University Hospital [Berne] (Inselspital), Transverse group for research in primary care [Barcelona], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat Politècnica de Catalunya [Barcelona] (UPC), University Medical Center [Utrecht], Skane University Hospital [Malmo], Lund University [Lund], Newcastle University [Newcastle], Newcastle Upon Tyne Hospitals NHS Foundation Trust, Universidad de Córdoba = University of Córdoba [Córdoba], Universidad Nacional de Córdoba [Argentina], Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), The Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Saint Petersburg University (SPBU), CAP Les Corts (CAPSBE), National and Kapodistrian University of Athens (NKUA), Santo Stefano Riabilitazione, University Hospitals Birmingham [Birmingham, Royaume-Uni], Centre National de la Recherche Scientifique (CNRS)-Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), Rheumatology Unit, Cordoba (Institute University of Biomedical Sciences University of Cordoba (IUCBC), Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa, and Salvy-Córdoba, Nathalie

Subjects
MESH: Antirheumatic Agents, Autoimmune diseases, MESH: Hydroxychloroquine, Matemàtiques i estadística::Matemàtica aplicada a les ciències [Àrees temàtiques de la UPC], Azathioprine, Administration, Ophthalmic, MESH: Cyclosporine, 0302 clinical medicine, Adrenal Cortex Hormones, MESH: Muscarinic Agonists, Epidemiology, Immunology and Allergy, 030212 general & internal medicine, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, treatment, Anti-Inflammatory Agents, Non-Steroidal, 92 Biology and other natural sciences::92B Mathematical biology in general [Classificació AMS], [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, MESH: Anti-Inflammatory Agents, Non-Steroidal, MESH: Administration, Ophthalmic, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Sjogren's Syndrome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Cyclosporine, Rituximab, MESH: Immunosuppressive Agents, MESH: Lubricant Eye Drops, sjøgren's syndrome, MESH: Saliva, Artificial, autoimmune diseases, Immunosuppressive Agents, medicine.drug, Hydroxychloroquine, medicine.medical_specialty, Biomatemàtica, Immunology, Muscarinic Agonists, General Biochemistry, Genetics and Molecular Biology, Lubricant Eye Drops, MESH: Adrenal Cortex Hormones, 03 medical and health sciences, Therapeutic approach, Rheumatology, medicine, Humans, Intensive care medicine, Glucocorticoids, Sjøgren's syndrome, Biomathematics, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Abatacept, Saliva, Artificial, Evidence-based medicine, medicine.disease, Belimumab, Treatment, stomatognathic diseases, MESH: Sjogren's Syndrome, MESH: Glucocorticoids, business, Rheumatism
Abstract

International audience; The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.

Published
2019
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20. Prediction of Remission in a French Early Arthritis Cohort by RAPID3 and other Core Data Set Measures, but Not by the Absence of Rheumatoid Factor, Anticitrullinated Protein Antibodies, or Radiographic Erosions

Author

Bruno Fautrel, Maxime Dougados, Francis Guillemin, Isabel Castrejón, Theodore Pincus, Bernard Combe, Rush University Medical Center [Chicago], Service de rhumatologie [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre d'Epidemiologie et Biostatistiques Sorbonne Paris Cité, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Division of Rheumatology (NYU Hospital - Rheumato), New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU)-NYU System (NYU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Male, MESH: Antirheumatic Agents, MESH: Remission Induction, Multivariate statistics, Databases, Factual, Health Status, Logistic regression, Severity of Illness Index, Anti-Citrullinated Protein Antibodies, Arthritis, Rheumatoid, Disability Evaluation, 0302 clinical medicine, Immunology and Allergy, 030212 general & internal medicine, RAPID3, MESH: Health Status, MESH: Treatment Outcome, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, medicine.diagnostic_test, Remission Induction, MESH: Disability Evaluation, Middle Aged, Prognosis, 3. Good health, Treatment Outcome, REMISSION CRITERIA, Antirheumatic Agents, Erythrocyte sedimentation rate, Rheumatoid arthritis, Cohort, Disease Progression, Female, MESH: Disease Progression, France, Adult, musculoskeletal diseases, medicine.medical_specialty, MESH: Rheumatoid Factor, Immunology, MESH: Prognosis, 03 medical and health sciences, ESPOIR, Rheumatology, Rheumatoid Factor, MESH: Severity of Illness Index, Internal medicine, medicine, Humans, Rheumatoid factor, RHEUMATOID ARTHRITIS, 030203 arthritis & rheumatology, MESH: Humans, business.industry, MESH: Adult, medicine.disease, MESH: Databases, Factual, MESH: Male, MESH: France, Physical therapy, MESH: Anti-Citrullinated Protein Antibodies, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female, Rheumatism
Abstract

Objective.To identify baseline variables that predict remission according to different criteria in rheumatoid arthritis (RA) in a comprehensive French ESPOIR early arthritis database.Methods.Individual variables and indices at baseline were analyzed in 664 patients for capacity to predict remission either 6 or 12 months later according to 4 criteria that require a formal joint count: the American College of Rheumatology/European League Against Rheumatism Boolean criteria, the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the 28-joint Disease Activity Score; and 2 remission criteria that do not require a formal joint count: the Routine Assessment of Patient Index Data 3 (RAPID3) and the RAPID3 ≤ 3 + swollen joint, using univariate and multivariate logistic regressions.Results.Remission was predicted significantly 6 and/or 12 months later in 26.8%–51.4% of patients, according to all 6 criteria by younger age, low index scores, and better status for the 6/7 clinical RA core dataset measures: tender joint count, swollen joint count (SJC), physician’s global estimate, patient self-report Health Assessment Questionnaire (HAQ) physical function, pain, and patient’s global estimate. Remission was not predicted by the absence of “poor prognosis RA” indicators, rheumatoid factor (RF), anticitrullinated protein antibodies (ACPA), or radiographic erosions. In multivariate regressions that included only 3 variables, low HAQ function predicted remission by all criteria as effectively as SJC, erythrocyte sedimentation rate, or C-reactive protein.Conclusion.Younger age and 6 core dataset clinical measures, but not the absence of traditional “poor prognosis RA” indicators, RF, ACPA, or radiographic erosions, predicted remission according to 6 criteria, including 2 without a formal joint count.

Published
2016
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21. Spondyloarthritis associated with familial Mediterranean fever: successful treatment with anakinra

Author

Sophie Georgin-Lavialle, Pauline M’Bappé, Serge Amselem, Katia Stankovic Stojanovic, Jérémie Sellam, Anne Miquel, Fawaz Awad, C Bachmeyer, Salam Abbara, Gilles Grateau, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Groupe de recherche clinique Amylose AA Sorbonne Université (GRC 28 - GRAASU), Sorbonne Université (SU), Physiopathologie des maladies génétiques d'expression pédiatrique, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], CHU Trousseau [APHP], Couvet, Sandrine, Service de Médecine Interne = Hôpital de jour de médecine [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Référence des Maladies Auto-Inflammatoires et des Amyloses [CHU Tenon] (CeréMAIA), Service de rhumatologie [Saint-Antoine], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de Radiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], and Service de génétique et embryologie médicales [CHU Trousseau]

Subjects
0301 basic medicine, MESH: Antirheumatic Agents, Pediatrics, medicine.medical_specialty, MESH: Spondylarthritis, [SDV]Life Sciences [q-bio], Treatment outcome, MEDLINE, Familial Mediterranean fever, [SDV.GEN.GH] Life Sciences [q-bio]/Genetics/Human genetics, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, medicine, Pharmacology (medical), Young adult, MESH: Treatment Outcome, 030203 arthritis & rheumatology, Anakinra, MESH: Humans, business.industry, MESH: Familial Mediterranean Fever, medicine.disease, MESH: Male, [SDV] Life Sciences [q-bio], MESH: Interleukin 1 Receptor Antagonist Protein, 030104 developmental biology, [SDV.GEN.GH]Life Sciences [q-bio]/Genetics/Human genetics, MESH: Young Adult, business, medicine.drug
Abstract

International audience

Published
2016
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22. Evaluation of extreme patient-reported outcome in early spondyloarthritis and its impact on the effect of TNF-α blockers treatment

Author

Meghnathi, Bhowmik, Claudepierre, Pascal, Dougados, Maxime, Moltó, Anna, Université Paris Descartes - Paris 5 (UPD5), Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Sorbonne Paris Cité (USPC), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, and Université Autonome de Barcelone

Subjects
Adult, Male, MESH: Antirheumatic Agents, MESH: Socioeconomic Factors, Time Factors, MESH: Biological Products, MESH: Spondylarthritis, MESH: Patient Reported Outcome Measures, MESH: Phenotype, MESH: Risk Factors, Risk Factors, Spondylarthritis, Humans, Patient Reported Outcome Measures, MESH: Treatment Outcome, Biological Products, MESH: Humans, MESH: Middle Aged, Tumor Necrosis Factor-alpha, MESH: Time Factors, MESH: Adult, Middle Aged, MESH: Male, MESH: Sickness Impact Profile, Phenotype, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Tumor Necrosis Factor-alpha, Antirheumatic Agents, MESH: Sexual Health, Female, MESH: Female
Abstract

To describe the prevalence of extreme patient-reported outcomes (PRO) in an early axial spondyloarthritis setting, to compare the phenotype of patients with/without extreme PRO and to evaluate the impact of extreme PRO on the effectiveness of TNF-α blockers (TNFb).This analysis was performed in the DESIR cohort. Extreme PRO were measured at baseline and were defined as a score ≥8 on at least three of first five BASDAI items. Phenotype of patient's with/without extreme PRO was compared. Impact of extreme PRO on TNFb effectiveness was evaluated by comparing the retention rate of the first TNFb in both groups by survival curves analysis (log-rank and Cox analysis).Extreme PRO were present in 95 out of the 708 patients (13.4%). Patients with extreme PRO were older (mean (SD) age of 35.4(8.6) years vs. 33.5(8.7) years), more frequently females (65.3% vs. 51.9%), had higher BASDAI (7.1 vs. 4.1), reported more frequently history of depression (25.3% vs. 10.2%) and use of anti-depressive drugs (19.0% vs. 7.2%). TNFb treatment was more frequently initiated in the extreme PRO group (48.4% vs. 25.5%), while the proportion of patients still on TNFb at 2 years was significantly lower in the extreme PRO group 18.6% (n=8) vs. 39.5% (n=60). Presence of extreme PRO was independently associated with first TNFb discontinuation (HR 1.8, [95% CI 1.2;2.9], p=0.01)).Although presence of extreme PRO in this early axSpA setting was not very frequent, patients with extreme PRO were more likely to receive a TNFb and less likely to maintain the treatment at 2 years. Further studies evaluating the specific impact of extreme PRO on TNFb treatment in axSpA are warranted.

Published
2017
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23. Current Practice for Therapeutic Drug Monitoring of Biopharmaceuticals in Rheumatoid Arthritis

Author

David Ternant, Philippe Goupille, Alejandro Balsa, Frédéric Medina, Denis Mulleman, Chamaida Plasencia, Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017] (GICC UMR 7292 CNRS), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), and University Hospital La Paz, Madrid

Subjects
Oncology, Drug, medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Biological Products, media_common.quotation_subject, Arthritis, Pharmacology, 030226 pharmacology & pharmacy, MESH: Antibodies, Monoclonal, Biopharmaceutics, Arthritis, Rheumatoid, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, MESH: Drug Monitoring, Internal medicine, Medicine, Animals, Humans, Pharmacology (medical), MESH: Animals, MESH: Biopharmaceutics, media_common, 030203 arthritis & rheumatology, MESH: Arthritis, Rheumatoid, Biological Products, MESH: Humans, medicine.diagnostic_test, business.industry, Tumor Necrosis Factor-alpha, Abatacept, Antibodies, Monoclonal, medicine.disease, 3. Good health, Biopharmaceutical, chemistry, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Therapeutic drug monitoring, Rheumatoid arthritis, MESH: Tumor Necrosis Factor-alpha, Antirheumatic Agents, Rituximab, Drug Monitoring, business, medicine.drug
Abstract

International audience; The treatment of rheumatoid arthritis (RA) has largely improved in the biopharmaceutical era. These compounds, primarily tumor necrosis factor (TNF) inhibitors, are effective, but some patients may show poor response, sometimes because of the presence of antidrug antibodies (ADAs). In some instances, clinicians may increase or taper the dose depending on the clinical response. Besides the current clinical-based practice, a tailored strategy based on drug monitoring has emerged as a way to improve the use of these drugs. However, the relevance of this therapeutic drug monitoring (TDM) of biopharmaceuticals in RA is still unknown. In this literature review, we examine the most relevant articles dealing with the concentration-response relationship, ADA detection and pharmacokinetics in RA patients receiving biopharmaceuticals. A concentration-response relationship was clearly established for TNF inhibitors. Moreover, ADA positivity was associated with low drug concentrations, poor clinical outcome, and reduced drug survival for TNF-inhibitor monoclonal antibodies. Concomitant use of disease-modifying antirheumatic drugs, especially methotrexate, is associated with good clinical outcome, increased drug concentrations, and reduced immunogenicity. Strategies based on TDM of TNF inhibitors seem promising for RA, but randomized controlled trials are required to support this. A concentration-response relationship may exist with tocilizumab, and immunogenicity seems rare. Finally, the relevance of TDM for RA patients receiving rituximab and abatacept remains unclear.

Published
2017
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24. Management of dyslipidaemia in high-risk patients with recent-onset rheumatoid arthritis: targets still not met despite specific recommendations. Results from the ESPOIR cohort during the first five years of follow-up

Author

Tournadre, Anne, Pereira, Bruno, Dubost, Jean-Jacques, Rincheval, Nathalie, Rat, Anne Christine, Combe, Bernard, Soubrier, Martin, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), service de Biostatistiques, DRCI, CHU Clermont-Ferrand, Service de Rhumatologie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), and Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, MESH: Antirheumatic Agents, Time Factors, MESH: Risk Assessment, Arthritis, Rheumatoid, MESH: Practice Guidelines as Topic, Risk Factors, MESH: Risk Factors, Prospective Studies, MESH: Hypolipidemic Agents, Hypolipidemic Agents, MESH: Treatment Outcome, MESH: Aged, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, MESH: Follow-Up Studies, Middle Aged, Lipids, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Cardiovascular Diseases, Antirheumatic Agents, Practice Guidelines as Topic, MESH: Guideline Adherence, Female, lipids (amino acids, peptides, and proteins), France, Guideline Adherence, MESH: Cholesterol, LDL, Adult, Risk Assessment, MESH: Cross-Sectional Studies, Humans, Aged, Dyslipidemias, MESH: Humans, MESH: Time Factors, MESH: Dyslipidemias, MESH: Cardiovascular Diseases, MESH: Adult, Cholesterol, LDL, MESH: Lipids, MESH: Prospective Studies, MESH: Male, MESH: France, Cross-Sectional Studies, MESH: Biomarkers, MESH: Female, Biomarkers, Follow-Up Studies
Abstract

Reduction of LDL-cholesterol (LDLc) is essential to decrease the cardiovascular mortality in rheumatoid arthritis (RA). Between 2005 and 2010, French recommendations for dyslipidaemia defined the LDLc target based on the number of cardiovascular risk factors. In 2006, it was recommended to consider LDLc objectives with RA being counted as an additional cardiovascular risk factor. Our objective was to assess lipid target achievement between 2006 and 2010 in a cohort of patients with recent-onset RA.814 patients were included between 2002 and 2005 in a French cohort of patients with early arthritis and a high probability of RA (ESPOIR). Repeated cross-sectional analyses for cardiovascular risk factors, cholesterol levels were performed every year from 2006 to 2010 to determine lipid profile and achievement of the LDLc goal according to the French guidelines.On the 620 patients analysed at the first point, 77% were female, 89.8% fulfilled the ACR criteria for RA and 2.7% received a statin. The proportion of patients failing to achieve the LDLc target did not improve following the publication of specific RA guidelines in 2006 (15.3 to 22.5% between 2006 and 2010). In patients with the highest cardiovascular risk, more than 58% did not reach the LDLc target.Specific recommendations for RA published in 2006 decreased LDLc target but did not improve management of dyslipidaemia in daily life which remained suboptimal particularly in patients at highest risk.

Published
2017

25. Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial

Author

Damien Loeuille, Emmanuel Maheu, P. Lafforgue, Y. Maugars, Gabriel Baron, Philippe Ravaud, Xavier Chevalier, P. Vergnaud, Violaine Foltz, Pascal Richette, Cédric Lukas, Caroline Roux, Denis Mulleman, Daniel Wendling, A. Rialland, Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Laboratoire Synarc, Hôpital Archet 2 [Nice] (CHU), Archéologie, Terre, Histoire, Sociétés [Dijon] (ARTeHiS), Centre National de la Recherche Scientifique (CNRS)-Université de Bourgogne (UB)-Ministère de la Culture et de la Communication (MCC), Service de rhumatologie [Nantes], Université de Nantes (UN)-Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Rhumatologie [CHU de Montpellier], CHU Montpellier, Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Rhumatologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Service de Rhumatologie [CHU Lariboisière], Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Ministère de la Culture et de la Communication (MCC)-Université de Bourgogne (UB)-Centre National de la Recherche Scientifique (CNRS), Service de Rhumatologie [CHU Pitié Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor, Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine] ( DHU i2B ), CHU Saint-Antoine [APHP]-Assistance publique - Hôpitaux de Paris (AP-HP), Centre d'Investigation Clinique Henri Mondor ( CIC Henri Mondor ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Hôpital Archet 2 [Nice] ( CHU ), Archéologie, Terre, Histoire, Sociétés [Dijon] ( ARTeHiS ), Ministère de la Culture et de la Communication ( MCC ) -Université de Bourgogne ( UB ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Nantes ( UN ) -Hôtel-Dieu-Centre hospitalier universitaire de Nantes ( CHU Nantes ), Service de rhumatologie [Tours], Service de Rhumatologie [CHRU de Besançon], Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -Hôpital de la Conception [CHU - APHM] ( LA CONCEPTION ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Ingénierie Moléculaire et Physiopathologie Articulaire ( IMoPA ), Université de Lorraine ( UL ) -Centre National de la Recherche Scientifique ( CNRS ), Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], and Hôpital Lariboisière

Subjects
Male, MESH: Antirheumatic Agents, MESH: Analgesics, MESH: Treatment Failure, MESH : Aged, Placebo-controlled study, MESH: Pain Measurement, Osteoarthritis, MESH: Adalimumab, Anti-TNF, [ SDV.BBM.BC ] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biomolecules [q-bio.BM], 0302 clinical medicine, MESH: Osteoarthritis, MESH : Anti-Inflammatory Agents, Non-Steroidal, Immunology and Allergy, MESH : Pain Measurement, MESH : Female, MESH: Double-Blind Method, Treatment Failure, Pain Measurement, MESH: Treatment Outcome, MESH: Aged, Analgesics, 0303 health sciences, MESH: Middle Aged, Anti-Inflammatory Agents, Non-Steroidal, Middle Aged, MESH : Antirheumatic Agents, MESH: Anti-Inflammatory Agents, Non-Steroidal, 3. Good health, Treatment Outcome, Antirheumatic Agents, MESH : Analgesics, Female, MESH: Pain, MESH : Pain, medicine.drug, MESH: Hand Joints, medicine.medical_specialty, Hand Joints, Visual analogue scale, MESH : Male, Immunology, Pain, MESH : Treatment Outcome, [ SDV.BBM.BM ] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, MESH : Hand Joints, Antibodies, Monoclonal, Humanized, Placebo, MESH : Antibodies, Monoclonal, Humanized, General Biochemistry, Genetics and Molecular Biology, MESH : Adalimumab, 03 medical and health sciences, MESH : Treatment Failure, Double-Blind Method, Rheumatology, Refractory, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Internal medicine, Adalimumab, medicine, Humans, MESH : Double-Blind Method, MESH : Middle Aged, [SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM], Adverse effect, Aged, 030304 developmental biology, 030203 arthritis & rheumatology, MESH: Humans, business.industry, MESH : Humans, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, medicine.disease, MESH : Osteoarthritis, MESH: Male, Surgery, Treatment, MESH: Antibodies, Monoclonal, Humanized, Hand Osteoarthritis, business, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Hand osteoarthritis
Abstract

International audience; To test the efficiency of tumour necrosis factor blockers (adalimumab) in patients with painful refractory (non-responders to analgesics and non-steroidal anti-inflammatory drugs (NSAIDs)) hand osteoarthritis (OA).We performed a randomised, double-blind, placebo-controlled, parallel group, multicentre study. Patients were randomised to: 1/1 adalimumab 40 mg for two subcutaneous injections at a 15-day interval or placebo and monitored for 6 months. The primary outcome was the percentage of patients with an improvement of more than 50% in global pain (Visual Analogue Scale) between week 0 (W0) and week 6 (W6). Secondary outcomes included the number of painful joints, swollen joints, morning stiffness duration, patient and practitioner global assessments, functional indexes for hand OA, and consumption of analgesics. Analysis on the mean primary outcome measure was done on patients who received at least one injection.99 patients were recruited and 85 patients were randomised. Among them, 37 patients in the placebo group and 41 in the adalimumab group received at least one injection and were evaluated at W6 (n=78) on the main efficacy outcome. Mean age was 62 years, 85% were women, and mean level of pain was 62 mm at W0. At W6, 35.1% in the adalimumab group versus 27.3% in the placebo group had a pain reduction ≥50% (RR 1.12 (95% CI 0.82 to 1.54; p=0.48). There were no statistical differences for all secondary end points. The rate of adverse events was similar in the two groups.Adalimumab was not superior to placebo to alleviate pain in patients with hand OA not responding to analgesics and NSAIDs.

Published
2014
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26. Who are the patients with early arthritis with worse than death scores on the EQ-5D? Results from the ESPOIR cohort

Author

Bruno Fautrel, Anne Christine Rat, C. Gaujoux-Viala, Francis Guillemin, Pierre Bourgeois, René Marc Flipo, Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Rhumatologie, Université Paris Diderot - Paris 7 ( UPD7 ), Maladies chroniques, santé perçue, et processus d'adaptation ( APEMAC ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Nancy, Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Département de Rhumatologie ( LILLE - Rhumatologie ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université de Lorraine (UL), Station de Technologie des Produits Végétaux (URTPV), Institut National de la Recherche Agronomique (INRA), Service de Rhumatologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie[Lille], Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Université Paris Diderot - Paris 7 (UPD7), Département de Rhumatologie (LILLE - Rhumatologie), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and CHU Pitié-Salpêtrière [AP-HP]

Subjects
Male, MESH: Antirheumatic Agents, [SDV]Life Sciences [q-bio], MESH: Logistic Models, MESH: Illness Behavior, MESH: Pain Measurement, MESH: Risk Assessment, Logistic regression, Severity of Illness Index, MESH : Early Diagnosis, Arthritis, Rheumatoid, Cohort Studies, Disability Evaluation, 0302 clinical medicine, MESH: Early Diagnosis, Sickness Impact Profile, Surveys and Questionnaires, MESH : Pain Measurement, MESH : Female, MESH : Illness Behavior, Pharmacology (medical), Longitudinal Studies, MESH : Risk Assessment, MESH: Longitudinal Studies, MESH: Cohort Studies, ComputingMilieux_MISCELLANEOUS, MESH : Adaptation, Physiological, Depression (differential diagnoses), Illness Behavior, Pain Measurement, MESH : Longitudinal Studies, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, MESH : Prognosis, 030503 health policy & services, MESH: Disability Evaluation, MESH : Questionnaires, MESH : Adult, Middle Aged, Prognosis, MESH : Antirheumatic Agents, Adaptation, Physiological, MESH: Quality-Adjusted Life Years, MESH: Sickness Impact Profile, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Cohort, Anxiety, MESH : Severity of Illness Index, Female, Quality-Adjusted Life Years, medicine.symptom, 0305 other medical science, Adult, medicine.medical_specialty, SF-36, MESH : Male, MESH : Cohort Studies, Mixed anxiety-depressive disorder, MESH : Disability Evaluation, Risk Assessment, MESH: Multivariate Analysis, MESH: Prognosis, 03 medical and health sciences, Rheumatology, EQ-5D, MESH: Severity of Illness Index, Internal medicine, medicine, Humans, MESH : Middle Aged, 030203 arthritis & rheumatology, MESH: Humans, [ SDV ] Life Sciences [q-bio], business.industry, MESH: Questionnaires, MESH : Humans, MESH : Multivariate Analysis, MESH: Adult, MESH : Quality-Adjusted Life Years, medicine.disease, MESH: Adaptation, Physiological, MESH: Male, Quality-adjusted life year, Early Diagnosis, Logistic Models, MESH : Sickness Impact Profile, MESH : Arthritis, Rheumatoid, Multivariate Analysis, Physical therapy, business, MESH: Female, MESH : Logistic Models
Abstract

International audience; OBJECTIVES: The EQ-5D is a five-dimension multi-attribute questionnaire widely used to calculate quality-adjusted life-year scores. We aimed to describe patients with early arthritis (EA) and EQ-5D < 0, a state worse than death, at baseline and over 2 years and determine aspects of EA associated with a negative score. METHODS: EQ-5D scores for 813 patients were longitudinally assessed over 24 months. Characteristics and health status of patients with EQ-5D < 0 were analysed. Multivariate logistic regression was used to determine aspects of EA associated with a negative score. RESULTS: At baseline, 90 (11%) patients had a negative EQ-5D score (median EQ-5D -0.052; range -0.530 to -0.011). Almost all patients had extreme pain/discomfort and at least moderate problems in anxiety/depression domain. These patients had lower educational level, greater disease activity, higher HAQ score (greater functional disability), greater pain and fatigue, lower Short Form 36 (SF-36) mental component scores and higher CRP levels than patients with EQ-5D ≥ 0 (all P < 0.001). In the logistic regression model, worse HAQ and SF-36 mental component scores were associated with EQ-5D < 0. Results were similar at 6, 12 and 24 months, with 25, 23 and 24 patients, respectively, in a state worse than death. CONCLUSION: Pain or discomfort, often severe, is a key domain of the EQ-5D for patients with EA in a health state worse than death, and poor HAQ and SF-36 mental component scores were always independently associated with a state worse than death. EA patients may have specific needs necessitating better management of pain and psychological state.

Published
2012
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27. Choice of second-line disease-modifying antirheumatic drugs after failure of methotrexate therapy for rheumatoid arthritis: A decision tree for clinical practice based on rheumatologists' preferences

Author

Frédéric Lioté, Xavier Le Loët, Club Rhumatismes et Inflammation, Olivier Meyer, Jean-Francis Maillefert, René-Marc Flipo, Francis Guillemin, Alain Saraux, Michel De Bandt, Daniel Wendling, Bruno Fautrel, Jean-Marie Berthelot, Bernard Combe, Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'investigation clinique - Epidémiologie clinique [Nancy] (CIC-EC), Centre d'investigation clinique [Nancy] (CIC), Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Bichat - Claude Bernard, Service de Rhumatologie, Hôtel-Dieu, Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Os et articulations, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Service de rhumatologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), and Normandie Université (NU)

Subjects
MESH: Antirheumatic Agents, MESH: Decision Trees, MESH: Treatment Failure, Arthritis, MESH: Antibodies, Anti-Idiotypic, MESH: Logistic Models, Logistic regression, Severity of Illness Index, Arthritis, Rheumatoid, 0302 clinical medicine, immune system diseases, Immunology and Allergy, MESH: Data Collection, Pharmacology (medical), Treatment Failure, 030212 general & internal medicine, Practice Patterns, Physicians', skin and connective tissue diseases, MESH: Arthritis, Rheumatoid, Data Collection, Antibodies, Anti-Idiotypic, 3. Good health, MESH: Interleukin 1 Receptor Antagonist Protein, MESH: Methotrexate, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rheumatoid arthritis, medicine.drug, musculoskeletal diseases, medicine.medical_specialty, MESH: Rheumatoid Factor, Immunology, Peptides, Cyclic, 03 medical and health sciences, Rheumatology, Rheumatoid Factor, MESH: Severity of Illness Index, Internal medicine, Severity of illness, medicine, Humans, Rheumatoid factor, MESH: Physician's Practice Patterns, MESH: Peptides, Cyclic, 030203 arthritis & rheumatology, Anakinra, MESH: Humans, Tumor Necrosis Factor-alpha, business.industry, Decision Trees, medicine.disease, Interleukin 1 Receptor Antagonist Protein, Logistic Models, Methotrexate, MESH: Tumor Necrosis Factor-alpha, Physical therapy, business
Abstract

Objective To survey rheumatologists' preferences for the choice of a second-line disease-modifying antirheumatic drug (DMARD) after inadequate response with methotrexate (MTX) therapy in rheumatoid arthritis (RA). Methods Thirty-six rheumatologists stated their preferences for RA treatment after inadequate response with MTX therapy (optimal dose at least 6 months). From the initial scenario, we derived 54 vignettes varying by rheumatoid factor or anti–cyclic citrullinated peptide antibody presence, swollen joint count, Disease Activity Score in 28 joints, and structural damage. Respondents stated their preference among 5 therapeutic options: MTX continuation, switch to another conventional DMARD, addition of another conventional DMARD, addition of anakinra, or addition of a tumor necrosis factor (TNF) blocker. Presentation by pairs yielded 10 combinations of strategies for each variant, totaling 540 vignettes; participants evaluated a random sample of 180 vignettes. Determinants of each top-ranked option were analyzed by logistic regression. The compilation of these data served to define a therapeutic algorithm. Results The responses of 33 rheumatologists were analyzable. Therapeutic preferences corresponded to the top-ranked options. For patients with mild or moderately active RA, either a switch or step-up strategy to another conventional DMARD was top ranked. TNF blockers were preferred for RA patients with high disease activity or progressive structural damage. On the basis of these preferences, we developed a simple decision tree for use in daily clinical practice. Conclusion Our simple, easy-to-use decision tree developed from rheumatologists' preferences for therapy after failure of MTX therapy in RA treatment may guide rheumatologists in daily practice to choose a second-line DMARD.

Published
2009
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28. Cardiovascular disease in patients with spondyloarthropathies

Author

Jean Christophe Cornily, Patrick Godon, Alain Saraux, Florence Arlès, Aurore Brondex, Jacques Mansourati, Gilles Quiniou, Ulric Vinsonneau, Département de Cardiologie (HIA - Cardio), Hôpital d'Instruction des armées, Optimisation des régulations physiologiques (ORPHY (EA 4324)), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, Service de Cardiologie, Brest, and Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST )

Subjects
MESH: Antirheumatic Agents, Pathology, MESH: Cyclooxygenase 2 Inhibitors, Spondyloarthropathy, Heart Valve Diseases, MESH: Comorbidity, Comorbidity, Disease, 030204 cardiovascular system & hematology, Risk profile, MESH: Atherosclerosis, MESH: Heart Conduction System, Lactones, 0302 clinical medicine, Risk Factors, MESH: Risk Factors, Medicine, Sulfones, Atrioventricular Block, HLA-B27 Antigen, Smoking, MESH: Genetic Predisposition to Disease, MESH: Sulfones, 3. Good health, Cardiovascular Diseases, Antirheumatic Agents, MESH: Lactones, MESH: Spondylarthropathies, MESH: Smoking, medicine.medical_specialty, Susceptibility gene, 03 medical and health sciences, Rheumatology, Heart Conduction System, MESH: Atrioventricular Block, Internal medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Genetic Predisposition to Disease, In patient, Cardiovascular mortality, 030203 arthritis & rheumatology, MESH: Humans, Cyclooxygenase 2 Inhibitors, Tumor Necrosis Factor-alpha, business.industry, MESH: Cardiovascular Diseases, MESH: Heart Valve Diseases, Atherosclerosis, medicine.disease, Increased risk, MESH: Tumor Necrosis Factor-alpha, Spondylarthropathies, MESH: HLA-B27 Antigen, business
Abstract

International audience; Spondyloarthropathies are associated with a greater cardiovascular risk than expected based on the cardiac lesions known to occur in these diseases. The prevalence of several conventional risk factors is high in spondyloarthropathy patients, and chronic inflammation also contributes to premature plaque formation. In addition, susceptibility genes for spondyloarthropathies may be associated with an increased risk of cardiovascular disease. Finally, several drugs used to treat spondyloarthropathies may contribute to the occurrence of cardiovascular events. A careful evaluation of the cardiovascular risk profile is a key component of the management of patients with spondyloarthropathies.

Published
2008
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29. Recommendations of the French Society for Rheumatology regarding TNFα antagonist therapy in patients with ankylosing spondylitis or psoriatic arthritis: 2007 update

Author

Pham, Thao, Fautrel, Bruno, Dernis, Emmanuelle, Goupille, Philippe, Guillemin, Francis, Le Loët, Xavier, Ravaud, Philippe, Claudepierre, Pascal, Miceli-Richard, Corinne, De Bandt, Michel, Breban, Maxime, Maillefert, Jean-Francis, Masson, Charles, Saraux, Alain, Schaeverbeke, Thierry, Wendling, Daniel, Mariette, Xavier, Combe, Bernard, Renseigné, Non, Service de Rhumatologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de rhumatologie, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d'investigation clinique - Epidémiologie clinique [Nancy] (CIC-EC), Centre d'investigation clinique [Nancy] (CIC), Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Service de Rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], CHU Bordeaux [Bordeaux], Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Hôpital Bicêtre-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Service de Rhumatologie [CHU Pitié Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
MESH: Antirheumatic Agents, medicine.medical_specialty, Health Status, MESH: Societies, Medical, MESH: Professional Practice, Arthritis, Severity of Illness Index, MESH: Antibodies, Monoclonal, 03 medical and health sciences, Psoriatic arthritis, 0302 clinical medicine, MESH: Practice Guidelines as Topic, Rheumatology, MESH: Rheumatology, MESH: Severity of Illness Index, Internal medicine, medicine, MESH: Arthritis, Psoriatic, Humans, Spondylitis, Ankylosing, 030212 general & internal medicine, BASDAI, MESH: Health Status, Societies, Medical, Leflunomide, 030203 arthritis & rheumatology, Ankylosing spondylitis, MESH: Humans, Tumor Necrosis Factor-alpha, business.industry, Arthritis, Psoriatic, Antibodies, Monoclonal, Professional Practice, MESH: Spondylitis, Ankylosing, medicine.disease, Infliximab, 3. Good health, Discontinuation, Surgery, MESH: France, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Tumor Necrosis Factor-alpha, Antirheumatic Agents, Practice Guidelines as Topic, France, business, medicine.drug
Abstract

International audience; OBJECTIVE: To update French Society for Rheumatology guidelines regarding the use of tumor necrosis factor alpha (TNFalpha) antagonists for treating patients with ankylosing spondylitis (AS) or psoriatic arthritis (PsA). METHODS: We used the method recommended by Shekelle et al. to update the original recommendations: a limited group of experts selected the items that required updating, the relevant literature was critically appraised, and the experts developed new wording for the recommendations, which was then subjected to internal and external validation. As with the original recommendations, three topics were addressed, namely, indications of TNFalpha antagonist therapy, treatment initiation, and treatment adjustment and follow-up. RESULTS: Four criteria should be used to evaluate the indication of TNFalpha antagonist therapy. First, the patient must have a definitive diagnosis of AS or PsA. Thus, patients with AS must meet modified New York criteria or exhibit characteristic involvement of the sacroiliac joints, spine, or peripheral sites documented by radiographs or computed tomography (structural damage) or by magnetic resonance imaging (inflammation). Patients with PsA must meet validated criteria such as the Moll and Wright or CASPAR criteria. The second criterion is active disease for more than 1month, with a BASDAI >or=4 in patients with predominantly axial disease or a tender/swollen joint count >or=3, and with a physician assessment of disease activity of >or=4/10. The third criterion is failure of at least three non-steroidal anti-inflammatory drugs in patients with axial disease or of disease-modifying antirheumatic drug (DMARD) therapy (methotrexate, salazopyrine, or leflunomide) in patients with peripheral disease. Fourth, the patient must be free of contraindications to TNFalpha antagonist therapy. Four recommendations pertain to the initiation of TNFalpha antagonist therapy: a workup should be performed prior to treatment initiation; there is no evidence that one TNFalpha antagonist is more effective than the others, so decisions about drug selection should be shared with the patient and guided by available safety data and the patient's profile; there is no proof that greater effectiveness can be achieved by routinely combining a conventional DMARD; and patients should receive regular standardized follow-up. The last four recommendations deal with adjusting TNFalpha antagonist therapy: the treatment objective is a 2-point or greater improvement in the BASDAI in patients with axial disease and a 30% or greater improvement in the tender/swollen joint counts in patients with peripheral disease; there is no evidence to support the introduction of DMARD therapy in non-responders, who can be switched to another TNFalpha antagonist or, when on infliximab, given higher dosages or more closely spaced injections; patients who fail to tolerate one TNFalpha antagonist can be switched to another TNFalpha antagonist if allowed by the nature of the adverse event; and when a remission is achieved, reduction or discontinuation of concomitant anti-inflammatory therapy should be considered, followed in the event of a prolonged remission by a reduction in the dosage of the TNFalpha antagonist.

Published
2007
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30. The use of TNF-α blocking agents in rheumatoid arthritis: an update

Author

Eric, Toussirot, Daniel, Wendling, Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)

Subjects
MESH: Antirheumatic Agents, MESH: Antibodies, Monoclonal, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, MESH: Antibodies, Blocking, Animals, Humans, MESH: Animals, Pharmacology (medical), Antibodies, Blocking, Randomized Controlled Trials as Topic, 030304 developmental biology, 030203 arthritis & rheumatology, Pharmacology, MESH: Arthritis, Rheumatoid, 0303 health sciences, MESH: Humans, Tumor Necrosis Factor-alpha, Antibodies, Monoclonal, General Medicine, 3. Good health, MESH: Randomized Controlled Trials as Topic, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, MESH: Tumor Necrosis Factor-alpha
Abstract

International audience; TNF-alpha has been found to play a pivotal role in the pathogenic mechanisms of rheumatoid arthritis (RA). Drugs targeting TNF-alpha have been developed to neutralise the deleterious effects of this inflammatory cytokine. There are, at present, three drugs available for the treatment of RA patients with active disease who are refractory to conventional treatments including methotrexate: 2 monoclonal antibodies, infliximab and adalimumab, and a fusion protein with p75 receptors, etanercept. These three agents have proved to be effective and safe in large placebo-controlled trials enrolling patients with established or early disease and showed effectiveness in controlling signs and symptoms of the disease, improving quality of life and in slowing and even arresting the progression of radiographic damage. With the long-term surveillance of these drugs were described serious adverse events, particularly infections such as tuberculosis, especially with infliximab. The risk for malignancies under TNF-alpha antagonists, especially lymphoma, remains controversial. Specific recommendations are given by international experts for selecting and monitoring RA patients with TNF-alpha antagonists. Other drugs targeting TNF-alpha such as PEGylated molecules (CDP870 or certolizumab) are in development. These new biological therapies blocking TNF-alpha undoubtedly constitute a considerable advancement in the management of RA, but careful evaluation at the initiation of the treatment and long-term surveillance of the patients receiving such drugs remains necessary.

Published
2007
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31. A single tumour necrosis factor haplotype influences the response to adalimumab in rheumatoid arthritis

Author

Xavier Mariette, Hartmut Kupper, Pascale Loiseau, Céline Verstuyft, Emmanuelle Comets, Laurent Becquemont, Ryad Tamouza, Philippe Ravaud, Corinne Miceli-Richard, Dominique Charron, Immunologie antivirale systémique et cérébrale, Université Paris-Sud - Paris 11 (UP11)-IFR93-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'investigation Biologique (CIB), Immunogénétique humaine, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Abbott GmbH & Co. KG, Comets, Emmanuelle, Hôpital Bicêtre-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7)

Subjects
Male, rheumatoid arthritis, haplotype, MESH: Antirheumatic Agents, Arthritis, Gastroenterology, MESH: Antibodies, Monoclonal, Arthritis, Rheumatoid, MESH: Genotype, 0302 clinical medicine, immune system diseases, adalimumab, Immunopathology, genetic polymorphism, Immunology and Allergy, MESH: Treatment Outcome, [INFO.INFO-BI] Computer Science [cs]/Bioinformatics [q-bio.QM], MESH: Aged, MESH: Arthritis, Rheumatoid, 0303 health sciences, MESH: Middle Aged, [SDV.BIBS] Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], MESH: Polymorphism, Single Nucleotide, Antibodies, Monoclonal, Middle Aged, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], 3. Good health, Treatment Outcome, MESH: Methotrexate, Antirheumatic Agents, Rheumatoid arthritis, Drug Therapy, Combination, Female, TNF-alpha, medicine.drug, Adult, musculoskeletal diseases, medicine.medical_specialty, Genotype, Immunology, Antibodies, Monoclonal, Humanized, Polymorphism, Single Nucleotide, Article, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Rheumatology, Internal medicine, medicine, Adalimumab, Humans, Aged, 030304 developmental biology, 030203 arthritis & rheumatology, Autoimmune disease, MESH: Humans, Tumor Necrosis Factor-alpha, business.industry, Haplotype, MESH: Adult, HLA-DR Antigens, MESH: Haplotypes, MESH: HLA-DR Antigens, medicine.disease, MESH: Male, MESH: Drug Therapy, Combination, Methotrexate, Haplotypes, MESH: Tumor Necrosis Factor-alpha, [INFO.INFO-BI]Computer Science [cs]/Bioinformatics [q-bio.QM], business, MESH: Female, HLA-DRB1 Chains
Abstract

Objective:To determine whether tumour necrosis factor (TNF) gene polymorphisms and/or the shared epitope are genetic predictors of the response to adalimumab (ADA) in rheumatoid arthritis (RA).Methods:This ancillary study to the Research in Active Rheumatoid Arthritis (ReAct) Phase IIIb study included a large cohort of Caucasian patients with RA from France (n = 388) treated with ADA plus methotrexate (MTX) (n = 182), ADA plus any other DMARD (n = 98) or ADA alone (n = 108). The primary outcome was ACR50 at 12 weeks. Patients underwent genotyping for HLA-DRB1 and three TNF gene polymorphisms (–238A/G,–308A/G and–857C/T). Extended haplotypes involving HLA-DRB1 and TNF loci were reconstructed using the PHASE program.Results:A total of 151 patients (40%) had an ACR50 response at week 12. Neither the number of HLA-DRB1 shared epitope copies nor presence of the three TNF polymorphisms tested separately was significantly associated with ACR50 response at week 12. However, haplotype reconstruction of the TNF locus revealed that the GGC haplotype (–238G/–308G/–857C) in a homozygous form (i.e. present in more than half of the patients) was significantly associated with a lower ACR50 response to ADA at 12 weeks (34% vs. 50% in patients without the haplotype) (p = 0.003; pa = 0.015). This effect was more important in the subgroup of patients concomitantly treated with MTX.Conclusion:This large pharmacogenetic study provides preliminary data indicating that a single TNF locus haplotype (–238G/–308G/–857C), present on both chromosomes is associated with a lower response to ADA, mainly in patients treated with ADA and MTX.

Published
2007
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32. Influence of −308 A/G polymorphism in the tumor necrosis factor α gene on etanercept treatment in rheumatoid arthritis

Author

Sandrine Guis, Olfert Landt, Leonor Nogueira, Guy Serre, Jean-Pierre Mattei, Bénédicte Mugnier, Pierre Legeron, Julien Bouvenot, Nathalie Balandraud, Eric Toussirot, Isabelle Auger, Daniel Wendling, Chantal Roudier, Jean Roudier, Evolution biologique, Université de Provence - Aix-Marseille 1-EA 3781, Immunogenetique de la Polyarthrite Rhumatoide, Université de la Méditerranée - Aix-Marseille 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre d'Immunologie de Marseille - Luminy (CIML), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité différenciation épidermique et auto-immunité rhumatoïde (UDEAR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Antirheumatic Agents, Arthritis, Severity of Illness Index, Group A, Gastroenterology, Receptors, Tumor Necrosis Factor, Etanercept, Arthritis, Rheumatoid, MESH: Genotype, 0302 clinical medicine, Immunopathology, Genotype, Immunology and Allergy, Pharmacology (medical), MESH: Treatment Outcome, MESH: Aged, MESH: Immunoglobulin G, MESH: Arthritis, Rheumatoid, 0303 health sciences, MESH: Middle Aged, MESH: Polymorphism, Single Nucleotide, Middle Aged, MESH: Predictive Value of Tests, 3. Good health, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rheumatoid arthritis, Female, medicine.drug, Adult, musculoskeletal diseases, medicine.medical_specialty, Immunology, Polymorphism, Single Nucleotide, 03 medical and health sciences, Rheumatology, Predictive Value of Tests, MESH: Severity of Illness Index, Internal medicine, medicine, Humans, Aged, 030304 developmental biology, 030203 arthritis & rheumatology, MESH: Humans, Tumor Necrosis Factor-alpha, business.industry, MESH: Adult, MESH: Receptors, Tumor Necrosis Factor, medicine.disease, MESH: Male, Infliximab, Immunoglobulin G, MESH: Tumor Necrosis Factor-alpha, Gene polymorphism, business, MESH: Female
Abstract

International audience; OBJECTIVE: To determine whether the -308 A/G tumor necrosis factor alpha (TNFalpha) gene polymorphism can predict the outcome of etanercept therapy in 86 patients with rheumatoid arthritis (RA), as already observed in patients treated with infliximab. METHODS: Eighty-six RA patients treated with etanercept were genotyped for -308 A/G TNFalpha gene polymorphism by polymerase chain reaction and melting curve analysis, using specific gene primers and probes. Patients were subdivided into group A (G/A genotype) and group G (G/G genotype). We compared clinical responses to etanercept between groups A and G after 6 months, using the Disease Activity Score in 28 joints (DAS28). After 12-month treatment, 48 of 86 patients were evaluated again. RESULTS: Of 86 patients, 18 (21%) belonged in group A and 68 (79%) belonged in group G. After 6-month treatment, 55.6% of patients in group A and 82.4% of patients in group G had DAS28 improvement >1.2 (P = 0.027 by chi-square). The mean +/- SD DAS28 improvement was 1.69 +/- 1.31 in group A and 2.23 +/- 1.19 in group G (P = 0.098 by t-test). After 1-year treatment 48 patients were tested again: 10 (21%) belonged in group A and 38 (79%) belonged in group G. Forty percent of patients in group A and 87% in group G had DAS28 improvement >1.2 (P = 0.005 by chi-square). The mean +/- SD DAS28 improvement was 1.334 +/- 1.37 in group A and 2.29 +/- 1.47 in group G (Mann-Whitney U test = 115, P = 0.0057). CONCLUSION: RA patients with a -308 G/G TNFalpha genotype respond to etanercept better than patients with a -308 A/G genotype.

Published
2007
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33. Predictive value of autoantibodies from anti-CCP2, anti-MCV and anti-human citrullinated fibrinogen tests, in early rheumatoid arthritis patients with rapid radiographic progression at 1 year: results from the ESPOIR cohort

Author

Degboé, Yannick, Constantin, Arnaud, Nigon, Delphine, Tobon, Gabriel, Cornillet, Martin, Schaeverbeke, Thierry, Chiocchia, Gilles, Nicaise-Roland, Pascale, Nogueira, Leonor, Serre, Guy, Cantagrel, Alain, Ruyssen-Witrand, Adeline, Saraux, Alain, Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Rhumatologie [CHU Toulouse], Pôle Inflammation, infection, immunologie et loco-moteur [CHU Toulouse] (Pôle I3LM Toulouse), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Unité différenciation épidermique et auto-immunité rhumatoïde (UDEAR), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service de Rhumatologie [CHU Pellegrin], Groupe hospitalier Pellegrin, Infection et inflammation (2I), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), CARBILLET, Véronique, Service de rhumatologie, Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], CHU Toulouse [Toulouse], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Mécanismes, Conséquences et Modulation de l'Inflammation Ostéo-articulaire, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse]-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Laboratoire de Biologie Cellulaire et Cytologie, Département de Rhumatologie, Université de Bordeaux (UB)-CHU Bordeaux [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Laboratoire d'Immunologie 'Autoimmunité et Hypersensibilités' [AP-HP Hôpital Bichat, Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)

Subjects
MESH: Fatigue, MESH: Antirheumatic Agents, [SDV]Life Sciences [q-bio], MESH: Infliximab, Autoimmunity, Early Arthritis, Fibrinogen, medicine.disease_cause, Gastroenterology, pronostic radiographique, Early Rheumatoid Arthritis, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Immunology and Allergy, MESH: Incidence, skin and connective tissue diseases, MESH: Treatment Outcome, MESH: Aged, MESH: Xerostomia, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Middle Aged, biology, MESH: Endpoint Determination, anticorps anti vimentine citrullinée mutée, 3. Good health, MESH: Reproducibility of Results, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Cohort, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Rituximab, Mutated citrullinated vimentin, Antibody, medicine.drug, musculoskeletal diseases, medicine.medical_specialty, polyarthrite rhumatoïde débutante, Immunology, Rheumatology, Internal medicine, medicine, MESH: Outcome Assessment (Health Care), MESH: Blood Sedimentation, MESH: Humans, business.industry, Autoantibody, MESH: Adult, medicine.disease, MESH: Male, MESH: Sjogren's Syndrome, Ant-CCP, MESH: Netherlands, biology.protein, business, MESH: Female, Rheumatism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, anticorps anti peptides citrullinés
Abstract

Objectives: We compared the ability of antibodies against cyclic citrullinated peptides (anti-CCP2), against mutated citrullinated vimentin (anti-MCV) and against citrullinated fibrinogen (AhFibA) to predict 1 year rapid radiographic progression (RRP; total Sharp score variation ≥5 points), in early rheumatoid arthritis (RA).Methods: We analysed 566 patients from the ESPOIR cohort with early RA fulfilling the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria at year 1. We assayed the 3 anticitrullinated peptide antibodies (ACPA) tests on baseline sera. We compared the performance of these 3 ACPA tests to predict first-year RRP, by comparing areas under the receiver operating characteristic curves (ROCs). We assessed the 1 year RRP risk by ACPA titres. We used a logistic multivariate regression to analyse RRP risk in terms either of ACPA positivity or titre: high (>3 times the N cut-off) and low (1 to 3N).Results: 145 patients displayed RRP. Areas under the ROCs were similar (0.60) for the 3 tests. High ACPA titres were associated with 1 year RRP, whatever the test was, and with similar ORs. Low+ anti-MCV titres were not associated with 1-year RRP, whereas low+ anti-CCP2 titres (p=0.0226) and low+ AhFibA titres (p=0.0332) were significantly associated. In multivariate analysis, 1 year RRP was associated with anti-CCP2 positivity (p, ObjectifsNous avons comparé la capacité des anticorps anti-CCP2, anti vimentine citrullinée mutée (anti-MCV) et anti fibrinogène humain citrulliné (AhFibA), à prédire la progression radiographique rapide à 1 an (RRP; variation du score de Sharp total ≥ 5 points), dans la polyarthrite rhumatoïde débutante (PR). MéthodesNous avons analysé 566 patients de la cohorte ESPOIR, présentant une PR débutante satisfaisant aux critères 2010 ACR/EULAR à la première année. La prédiction de la RRP à 1 an a été analysée par des courbes ROC pour les 3 ACPA évalués par sérologie à l’inclusion. Nous avons évalué l’association entre les titres d’ACPA et le risque de RRP à 1 an. Une régression logistique multivariée a été utilisée pour analyser le risque de RRP, en termes de positivité ou de titre élevé (>3 fois le seuil de positivité N) et faible (1 à 3N) des ACPA. RésultatsLes aires sous les courbes ROC étaient similaires (0,60) pour les 3 anticorps. Les titres faibles d’anti-MCV n’étaient pas associés à la RRP, contrairement aux titres faibles d’anti-CCP2 (p=0,0226) et d’AhFibA (p=0,0332). En analyse multivariée, la RRP à 1 an était associée aux titres élevés d’anti-MCV (p

Published
2015
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34. Clinical practice decision tree for the choice of the first disease modifying antirheumatic drug for very early rheumatoid arthritis: a 2004 proposal of the French Society of Rheumatology

Author

Frédéric Lioté, M De Bandt, Francis Guillemin, A. Saraux, X. Le Loët, Daniel Wendling, René-Marc Flipo, J.-M. Berthelot, Alain Cantagrel, O. Meyer, J.-F. Maillefert, Bernard Combe, Bruno Fautrel, Service de rhumatologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Physiopathologie et biothérapies des maladies inflammatoires et autoimmunes, Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut de Génétique Moléculaire de Montpellier (IGMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Service de rhumatologie, Hôpital Robert Ballanger [Aulnay-sous-Bois], Rhumatologie, Université Paris Diderot - Paris 7 (UPD7), Os et articulations, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de génie électrique de Paris (LGEP), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Ecole Supérieure d'Electricité - SUPELEC (FRANCE)-Centre National de la Recherche Scientifique (CNRS), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre de Recherche en Automatique de Nancy (CRAN), Université Henri Poincaré - Nancy 1 (UHP)-Institut National Polytechnique de Lorraine (INPL)-Centre National de la Recherche Scientifique (CNRS), Centre Alexis Vautrin (CAV), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Service de rhumatologie [Rouen], CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Physiopathologie de la Résorption Osseuse et Thérapie des Tumeurs Osseuses Primitives, Université de Nantes ( UN ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de physiopathologie de Toulouse Purpan ( CPTP ), Université Paul Sabatier - Toulouse 3 ( UPS ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Institut de Génétique Moléculaire de Montpellier ( IGMM ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Université Paris Diderot - Paris 7 ( UPD7 ), Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Laboratoire de génie électrique de Paris ( LGEP ), Université Paris-Sud - Paris 11 ( UP11 ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -SUPELEC-Centre National de la Recherche Scientifique ( CNRS ), Immunologie et Pathologie ( EA2216 ), Université de Brest ( UBO ) -IFR148, Centre d'Investigation Clinique ( CIC - Brest ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz, Agents pathogènes et inflammation - UFC (EA 4266) ( API ), Université de Franche-Comté ( UFC ), Hôpital Jean Minjoz, Centre de Recherche en Automatique de Nancy ( CRAN ), Université Henri Poincaré - Nancy 1 ( UHP ) -Institut National Polytechnique de Lorraine ( INPL ) -Centre National de la Recherche Scientifique ( CNRS ), Centre Alexis Vautrin ( CAV ), and Université de Lorraine ( UL ) -Centre National de la Recherche Scientifique ( CNRS )

Subjects
MESH: Antirheumatic Agents, MESH: Decision Trees, medicine.medical_treatment, Arthritis, Choice Behavior, Severity of Illness Index, Etanercept, Arthritis, Rheumatoid, 0302 clinical medicine, MESH: Practice Guidelines as Topic, Immunology and Allergy, 030212 general & internal medicine, skin and connective tissue diseases, Societies, Medical, MESH: Treatment Outcome, Leflunomide, MESH: Arthritis, Rheumatoid, MESH : Antirheumatic Agents, 3. Good health, Extended Report, MESH : Rheumatoid Factor, Antirheumatic Agents, MESH : Practice Guidelines as Topic, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Practice Guidelines as Topic, MESH : Severity of Illness Index, France, medicine.drug, musculoskeletal diseases, medicine.medical_specialty, MESH: Rheumatoid Factor, MESH: Societies, Medical, Immunology, MESH : Treatment Outcome, MESH : Decision Trees, MESH: Choice Behavior, General Biochemistry, Genetics and Molecular Biology, [ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, 03 medical and health sciences, Rheumatology, Rheumatoid Factor, MESH: Severity of Illness Index, Internal medicine, MESH : Choice Behavior, medicine, Humans, MESH : Societies, Medical, Rheumatoid factor, Disease-modifying antirheumatic drug, MESH : France, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Decision Trees, MESH : Humans, MESH: Biological Markers, medicine.disease, MESH : Biological Markers, MESH: France, MESH : Arthritis, Rheumatoid, Physical therapy, business, Biomarkers
Abstract

International audience; OBJECTIVE: To elaborate a clinical practice decision tree for the choice of the first disease modifying antirheumatic drug (DMARD) for untreated rheumatoid arthritis of less than six months' duration. METHODS: Four steps were employed: (1) review of published reports on DMARD efficacy against rheumatoid arthritis; (2) inventory of the information available to guide DMARD choice; (3) selection of the most pertinent information by 12 experts using a Delphi method; and (4) choice of DMARDs in 12 clinical situations defined by items selected in step 3 (28 joint disease activity score (DAS 28): < or =3.2; >3.2 and < or =5.1; >5.1; rheumatoid factor status (positive/negative); structural damage (with/without)-that is, 3 x 2 x 2). Thus, multiplied by all the possible treatment pairs, 180 scenarios were obtained and presented to 36 experts, who ranked treatment choices according to the Thurstone pairwise method. RESULTS: Among the 77 items identified, 41 were selected as pertinent to guide the DMARD choice. They were reorganised into five domains: rheumatoid arthritis activity, factors predictive of structural damage; patient characteristics; DMARD characteristics; physician characteristics. In the majority of situations, the two top ranking DMARD choices were methotrexate and leflunomide. Etanercept was an alternative for these agents when high disease activity was associated with poor structural prognosis and rheumatoid factor positivity. CONCLUSIONS: Starting with simple scenarios and using the pairwise method, a clinical decision tree could be devised for the choice of the first DMARD to treat very early rheumatoid arthritis.

Published
2006
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35. The effect on treatment response of fibromyalgic symptoms in early rheumatoid arthritis patients: results from the ESPOIR cohort

Author

Jingbo Niu, Nathalie Rincheval, Bernard Combe, Josefina Durán, David T. Felson, Cécile Gaujoux-Viala, Clinical Epidemiology Research and Training Unit ( BOSTON - Clin Epid Research ), Boston University School, Rheumatology Department ( Rheum Dep - SANTIAGO ), Pontificia Universidad Catolica del Chile, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ) -Hôpital Lapeyronie, Institut de Génétique Moléculaire de Montpellier ( IGMM ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Department of rheumatology, University of Nimes, Arthritis Research UK Epidemiology Unit ( MANCHESTER - Arthritis Research ), University of Manchester [Manchester], Centre d'Investigation Clinique INSERM 1412 ( CIC 1412 - BREST ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), CHRU Brest - Service de Rhumatologie ( CHU - BREST - Rhumato ), Lymphocyte B et Auto-immunité ( LBAI ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Clinical Epidemiology Research and Training Unit (BOSTON - Clin Epid Research), Boston University School of Medicine (BUSM), Boston University [Boston] (BU)-Boston University [Boston] (BU), Rheumatology Department (Rheum Dep - SANTIAGO), Pontificia Universidad Católica de Chile (UC), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Arthritis Research UK Epidemiology Unit (MANCHESTER - Arthritis Research), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Boston University [Boston] (BU), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)

Subjects
Male, rheumatoid arthritis, MESH: Remission Induction, MESH: Antirheumatic Agents, MESH : Fibromyalgia, [SDV]Life Sciences [q-bio], early rheumatoid arthritis, MESH : Aged, Arthritis, Severity of Illness Index, DMARDs, Arthritis, Rheumatoid, Cohort Studies, fibromyalgic RA, 0302 clinical medicine, Fibromyalgia, MESH : Female, Pharmacology (medical), 030212 general & internal medicine, Prospective cohort study, skin and connective tissue diseases, MESH: Cohort Studies, ComputingMilieux_MISCELLANEOUS, MESH: Treatment Outcome, MESH: Aged, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Remission Induction, MESH: Follow-Up Studies, Middle Aged, Clinical Science, MESH : Adult, Corrigenda, MESH : Antirheumatic Agents, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Young Adult, Antirheumatic Agents, Rheumatoid arthritis, Cohort, Female, fibromyalgia, MESH : Severity of Illness Index, Adult, musculoskeletal diseases, medicine.medical_specialty, Adolescent, MESH : Male, MESH : Young Adult, MESH : Cohort Studies, MESH : Treatment Outcome, [ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Young Adult, outcome measures, 03 medical and health sciences, Rheumatology, Internal medicine, MESH: Severity of Illness Index, disease activity scores, MESH : Adolescent, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, medicine, Humans, MESH : Middle Aged, Aged, MESH: Adolescent, 030203 arthritis & rheumatology, therapy, MESH : Remission Induction, MESH: Fibromyalgia, MESH: Humans, DASS, [ SDV ] Life Sciences [q-bio], Surrogate endpoint, business.industry, MESH : Humans, MESH: Adult, MESH : Follow-Up Studies, medicine.disease, Crohn's Disease Activity Index, MESH: Male, MESH : Arthritis, Rheumatoid, Physical therapy, business, treat to target, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; OBJECTIVE:To evaluate whether patients with RA who belong to the spectrum of fibromyalgic RA (FRA) have an impaired response to treatment measured by traditional activity scores.METHODS:Patients from the ESPOIR cohort were analysed. This prospective cohort included 813 patients with early arthritis not initially receiving DMARDs. Among the 697 patients who met RA classification criteria, we studied two groups, one with and the other without FRA. The following endpoints were compared at 6, 12 and 18 months using a mixed linear regression model: 28-joint DAS (DAS28), Simple Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI) and HAQ. In addition, attainment of low disease activity (LDA; DAS28

Published
2017
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36. Response to tocilizumab in rheumatoid arthritis is not influenced by the body mass index of the patient

Author

Philippe Gaudin, Yves-Marie Pers, Joseph Lambert, Thibault Mura, Béatrice Pallot-Prades, Marie Godfrin-Valnet, Daniel Wendling, Christian Jorgensen, Elodie Constant, Clémentine Fortunet, Jean-Francis Maillefert, Hubert Marotte, Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Antirheumatic Agents, RESPONSE, Logistic regression, Body Mass Index, Arthritis, Rheumatoid, chemistry.chemical_compound, Immunology and Allergy, skin and connective tissue diseases, health care economics and organizations, MESH: Treatment Outcome, MESH: Aged, 2. Zero hunger, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Confounding, Middle Aged, 3. Good health, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Female, musculoskeletal diseases, medicine.medical_specialty, education, Immunology, Antibodies, Monoclonal, Humanized, MESH: Body Mass Index, Tocilizumab, Rheumatology, Internal medicine, medicine, Humans, In patient, RHEUMATOID ARTHRITIS, TOCILIZUMAB, Aged, Retrospective Studies, MESH: Humans, business.industry, MESH: Retrospective Studies, Retrospective cohort study, medicine.disease, MESH: Male, Surgery, chemistry, MESH: Antibodies, Monoclonal, Humanized, business, MESH: Female, Body mass index, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Rheumatism
Abstract

Objective.To assess the relationship between the body mass index (BMI) and the efficacy of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA).Methods.We conducted a retrospective study in 222 patients with RA followed by 5 centers. The European League Against Rheumatism response was evaluated at 6 months. Univariate and multivariate logistic regressions were performed.Results.No significant association between the BMI and the response to TCZ at 6 months was found after adjustment for potential confounding factors (adjusted OR 0.45, 95% CI 0.16–1.24, p = 0.13 and OR 1.19, 95% CI 0.31–4.48, p = 0.78 for BMI 25–30 kg/m2 and BMI > 30 kg/m2, respectively, compared to BMI < 25 kg/m2).Conclusion.Response to TCZ in patients with RA is not influenced by the baseline BMI, in contrast to anti-tumor necrosis factor drugs.

Published
2014
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37. A plea for reason in using magnetic resonance imaging for the diagnostic and therapeutic management of spondyloarthropathies

Author

Thao Pham, Pascal Claudepierre, Daniel Wendling, Philippe Goupille, Génétique, immunothérapie, chimie et cancer (GICC), UMR 6239 CNRS [2008-2011] (GICC UMR 6239 CNRS), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), Service de rhumatologie, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de Rhumatologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Cambefort, Jeanne, and Université de Tours-Centre National de la Recherche Scientifique (CNRS)

Subjects
MESH: Antirheumatic Agents, medicine.medical_specialty, [SDV]Life Sciences [q-bio], MEDLINE, MESH: Magnetic Resonance Imaging, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Magnetic resonance imaging, 0302 clinical medicine, Plea, Rheumatology, X ray computed, Diagnosis, medicine, Humans, Spondyloarthropathies, MESH: Sacroiliac Joint, MESH: Case Management, ComputingMilieux_MISCELLANEOUS, 030203 arthritis & rheumatology, MESH: Humans, medicine.diagnostic_test, Tumor Necrosis Factor-alpha, business.industry, Sacroiliac Joint, Case management, Spine, 3. Good health, [SDV] Life Sciences [q-bio], Treatment, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, MESH: Tumor Necrosis Factor-alpha, Spondylarthropathies, Radiology, Tomography, X-Ray Computed, MESH: Tomography, X-Ray Computed, Nuclear medicine, business, Case Management, MESH: Spine, MESH: Spondylarthropathies, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience

Published
2009
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38. ESPOIR and the French database management: what have we learned from the first years of follow-up?

Author

Combe, B, Saraux, Alain, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), and Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)

Subjects
MESH: Antirheumatic Agents, Time Factors, Databases, Factual, [SDV]Life Sciences [q-bio], MESH: Risk Assessment, Risk Assessment, Severity of Illness Index, Arthritis, Rheumatoid, Rheumatology, Predictive Value of Tests, Risk Factors, MESH: Risk Factors, MESH: Early Diagnosis, MESH: Severity of Illness Index, MESH: Rheumatology, Humans, MESH: Treatment Outcome, MESH: Arthritis, Rheumatoid, MESH: Humans, MESH: Time Factors, MESH: Databases, Factual, MESH: Predictive Value of Tests, MESH: France, Early Diagnosis, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Disease Progression, MESH: Disease Progression, France, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; ESPOIR (Etude et Suivi des POlyarthrites Indifférenciées Récentes) is a multicentre national cohort sponsored by the French Society for Rheumatology. The patients had early arthritis (

Published
2014

39. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study)

Author

Karim Sacre, Nathalie Costedoat-Chalumeau, Moez Jallouli, Olivier Fain, Véronique Le Guern, Amar Smail, Jean-Emmanuel Kahn, Thomas Papo, Lucile Musset, Laurent Perard, Philippe Lechat, Bouchra Asli, Gaëlle Leroux, Patrice Cacoub, Camille Francès, Nicolas Limal, Jacques Pourrat, Frédéric Lioté, Laurent Sailler, Jérôme Stirnemann, Marie-Laure Tanguy, Zahir Amoura, Hélène Desmurs-Clavel, Du Le Thi Huong Boutin, Judith Cohen-Bittan, Jean-Charles Piette, Jean-Sébastien Hulot, O. Aumaître, Felix Ackermann, Lionel Galicier, Immunologie - Immunopathologie - Immunothérapeutique (I3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service d'immunologie clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de médecine interne, hôpital Gabriel-Montpied, CHU Clermont-Ferrand, Service de Dermatologie [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Tenon [APHP], CHU Saint-Antoine [APHP], Service de Médecine Interne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP]-Université Paris Descartes - Paris 5 (UPD5), Service Rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 (UPD7), Laboratoire d'Immunologie (EA 2686), Université de Lille, Droit et Santé, Service de Néphrologie - Immunologie Clinique [Toulouse], CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse]-PRES Université de Toulouse, Hôpital Bichat - Claude Bernard, Service de médecine interne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Jean Verdier [Bondy], Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de médecine interne [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Biologie et thérapeutique des pathologies immunitaires (BTPI), Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC), Institut des Maladies Neurodégénératives [Bordeaux] (IMN), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Service de biostatistiques et information médicale [CHU Pitié-Salpêtrière], Physiopathologie, génétique et pharmacologie du remodelage cardiovasculaire, Université Pierre et Marie Curie - Paris 6 (UPMC)-IFR14-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'immunologie [CHU Pitié-Salpétrière], Immunité et Infection, Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR113-Université Pierre et Marie Curie - Paris 6 (UPMC), Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Médecine Interne [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de dermatologie et allergologie [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Jean Verdier [AP-HP], Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS), Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Immunologie [CHU Pitié-Salpétrière], Université de Brest (UBO)-Université de Brest (UBO), Immunologie - Immunopathologie - Immunothérapeutique ( I3 ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Tenon [APHP], Centre de Référence des microangiopathies thrombotiques ( CNR-MAT ), service d'hématologie-CHU Saint-Antoine [APHP], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]-Université Paris Descartes - Paris 5 ( UPD5 ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 ( UPD7 ), Laboratoire d'Immunologie ( EA 2686 ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Jean Verdier, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Biologie et thérapeutique des pathologies immunitaires ( BTPI ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Centre National de la Recherche Scientifique ( CNRS ), Institut des Maladies Neurodégénératives [Bordeaux] ( IMN ), Université de Bordeaux ( UB ) -Centre National de la Recherche Scientifique ( CNRS ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -IFR14-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -IFR113-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Département de Médecine Interne et Pneumologie [Brest] ( DMIP - Brest ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Groupe d'Etude de la Thrombose de Bretagne Occidentale ( GETBO ), Université de Brest ( UBO ), Centre d'Investigation Clinique ( CIC - Brest ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-PRES Université de Toulouse, Université Pierre et Marie Curie - Paris 6 (UPMC)-IFR113-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM)

Subjects
Male, MESH: Antirheumatic Agents, MESH: Hydroxychloroquine, [SDV]Life Sciences [q-bio], MESH : Prospective Studies, MESH : Dose-Response Relationship, Drug, Gastroenterology, law.invention, MESH: Dose-Response Relationship, Drug, 0302 clinical medicine, Randomized controlled trial, Dosing schedules, law, immune system diseases, MESH: Drug Monitoring, Epidemiology, Clinical endpoint, Lupus Erythematosus, Systemic, MESH : Lupus Erythematosus, Systemic, Immunology and Allergy, MESH : Female, MESH: Double-Blind Method, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, skin and connective tissue diseases, MESH: Treatment Outcome, MESH: Middle Aged, MESH : Adult, Middle Aged, MESH : Antirheumatic Agents, MESH : Drug Monitoring, Connective tissue disease, 3. Good health, Treatment Outcome, Antirheumatic Agents, Female, France, Drug Monitoring, Drug Monitoring/methods, Hydroxychloroquine, medicine.drug, Adult, medicine.medical_specialty, MESH : Male, Immunology, MESH : Treatment Outcome, General Biochemistry, Genetics and Molecular Biology, Hydroxychloroquine/administration & dosage/blood, 03 medical and health sciences, Rheumatology, Pharmacokinetics, Double-Blind Method, Internal medicine, medicine, MESH : Double-Blind Method, Humans, MESH : Middle Aged, MESH: Lupus Erythematosus, Systemic, MESH : France, Antirheumatic Agents/administration & dosage/blood, 030203 arthritis & rheumatology, MESH: Humans, [ SDV ] Life Sciences [q-bio], Dose-Response Relationship, Drug, business.industry, MESH : Humans, MESH : Hydroxychloroquine, MESH: Adult, medicine.disease, MESH: Male, MESH: Prospective Studies, Surgery, MESH: France, Lupus Erythematosus, Systemic/drug therapy, business, MESH: Female
Abstract

International audience; INTRODUCTION: Hydroxychloroquine (HCQ) is an important medication for treating systemic lupus erythematosus (SLE). Its blood concentration ([HCQ]) varies widely between patients and is a marker and predictor of SLE flares. This prospective randomised, double-blind, placebo-controlled, multicentre study sought to compare standard and adjusted HCQ dosing schedules that target [HCQ] ≥1000 ng/ml to reduce SLE flares. PATIENTS AND METHODS: [HCQ] was measured in 573 patients with SLE (stable disease and SELENA-SLEDAI≤12) treated with HCQ for at least 6 months. Patients with [HCQ] from 100 to 750 ng/ml were randomised to one of two treatment groups: no daily dose change (group 1) or increased HCQ dose to achieve the target [HCQ] (group 2). The primary end point was the number of patients with flares during 7 months of follow-up. RESULTS: Overall, mean [HCQ] was 918±451 ng/ml. Active SLE was less prevalent in patients with higher [HCQ]. A total of 171 patients were randomised and followed for 7 months. SLE flare rates were similar in the two groups (25% in group 1 vs 27.6% in group 2; p=0.7), but a significant spontaneous increase in [HCQ] in both groups between inclusion and randomisation strongly suggested improved treatment adherence. Patients at the therapeutic target throughout follow-up tended to have fewer flares than those with low [HCQ] (20.5% vs 35.1%, p=0.12). CONCLUSIONS: Although low [HCQ] is associated with higher SLE activity, adapting the HCQ dose did not reduce SLE flares over a 7-month follow-up.

Published
2013
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40. GUEPARD treat-to-target strategy is significantly more efficacious than ESPOIR routine care in early rheumatoid arthritis according to patient-reported outcomes and physician global estimate

Author

Martin Soubrier, Anne Christine Rat, Isabel Castrejón, Yih Chang Lin, Theodore Pincus, Maxime Dougados, Bernard Combe, Division of Rheumatology (NYU Hospital - Rheumato), New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU)-NYU System (NYU), NYU Hospital for Joint Diseases, Service de Rhumatologie [CHU Gabriel-Montpied], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Cleveland Clinic, Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Service de rhumatologie [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)

Subjects
Male, rheumatoid arthritis, treat-to-target, MESH: Antirheumatic Agents, MESH: Self Report, assessment, MESH: Pain Measurement, Physical function, Severity of Illness Index, Arthritis, Rheumatoid, 0302 clinical medicine, Medicine, Pharmacology (medical), 030212 general & internal medicine, Routine care, Pain Measurement, MESH: Treatment Outcome, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Clinical Science, Middle Aged, 3. Good health, Treatment Outcome, patient-reported outcomes, Antirheumatic Agents, Rheumatoid arthritis, Female, MESH: Pain, Adult, medicine.medical_specialty, Pain, 03 medical and health sciences, Rheumatology, MESH: Severity of Illness Index, Severity of illness, Humans, 030203 arthritis & rheumatology, patient questionnaires, MESH: Humans, business.industry, Treat to target, MESH: Adult, Early rheumatoid arthritis, medicine.disease, Crohn's Disease Activity Index, MESH: Male, Clinical trial, Physical therapy, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Self Report, business, MESH: Female
Abstract

International audience; Objective. To analyse seven RA Core Data Set measures and three indices for their capacity to distinguish treatment results in early RA in the GUEPARD treat-to-target clinical trial vs ESPOIR routine care.Methods. Post hoc analyses compared 65 GUEPARD and 130 matched control ESPOIR patients over 6 and 12 months for mean changes in measures, relative efficiencies and standardized response means (SRM). Three indices—28-joint disease activity score (DAS28), clinical disease activity index (CDAI) and routine assessment of patient index data (RAPID3)—were compared for mean changes and numbers of patients with high, moderate or low activity or remission using κ values.Results. Greater improvement was seen for GUEPARD vs ESPOIR, statistically significant for physician and patient global estimates and pain and health assessment questionnaire physical function (HAQ-FN), but not joint counts and laboratory tests. Relative efficiencies with tender joint count as the referent measure indicated that pain (2.57) and global estimates by patient (3.13) and physician (2.31) were most efficient in distinguishing GUEPARD from ESPOIR. Mean improvements in GUEPARD vs ESPOIR were −3.4 vs −2.6 for DAS28 (0–10) (24%), −29.8 vs −23.1 for CDAI (0–76) (23%) and −13.0 vs −7.8 for RAPID3 (0–30) (40%) (all P < 0.01); agreement was moderate between CDAI vs DAS28 (κ = 0.56) and vs RAPID3 (κ = 0.48), and fair between DAS28 vs RAPID3 (κ = 0.26).Conclusion. Patient and global measures indicate greater efficacy than joint counts or laboratory measures in detecting difference between GUEPARD treat-to-target and ESPOIR routine care. A RAPID3 of only patient measures may help guide treat-to-target in busy clinical settings.

Published
2013
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41. Hydroxychloroquine-induced pigmentation in patients with systemic lupus erythematosus: a case-control study

Author

Frédéric Lioté, Kim Heang Ly, Jean Sibilia, Bahram Bodaghi, Frederique Gandjbakhch, ERIC HACHULLA, David Launay, Noël ZAHR, HK Ea, Patrice Cacoub, Thomas Papo, JEAN EMMANUEL KAHN, Benoit Brihaye, David Saadoun, Emmanuel Chatelus, Alexis MATHIAN, Eric DAUGAS, Lamiae Grimaldi-Bensouda, Karim Sacre, Leonardo Astudillo, Service de dermatologie et allergologie [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de médecine interne [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Immunologie [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Immunologie - Immunopathologie - Immunothérapeutique (I3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Immunité et Infection, Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR113-Université Pierre et Marie Curie - Paris 6 (UPMC), Institut des Maladies Neurodégénératives [Bordeaux] (IMN), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Biologie et thérapeutique des pathologies immunitaires (BTPI), Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS), Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Dermatologie [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) - CHU Tenon [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) - CHU Pitié-Salpêtrière [APHP], Service de Pharmacologie, CHU Pitié-Salpêtrière [APHP], Service d'immunologie [CHU Pitié-Salpétrière], Centre National de la Recherche Scientifique (CNRS) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Université Pierre et Marie Curie - Paris 6 (UPMC), Université Pierre et Marie Curie - Paris 6 (UPMC) - IFR113 - Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'imagerie neuro-fonctionnelle (GINF), Commissariat à l'énergie atomique et aux énergies alternatives (CEA) - Université de Caen Basse-Normandie - Université Paris Descartes - Paris 5 (UPD5) - Centre National de la Recherche Scientifique (CNRS), Université Pierre et Marie Curie - Paris 6 (UPMC) - Centre National de la Recherche Scientifique (CNRS), CHU Brest, Université de Bretagne Occidentale (UBO), Université de Bretagne Occidentale (UBO) - Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC)-IFR113-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM)

Subjects
Male, MESH: Antirheumatic Agents, Time Factors, MESH: Hydroxychloroquine, [SDV]Life Sciences [q-bio], Ecchymosis, MESH: Logistic Models, Easy Bruising, 030207 dermatology & venereal diseases, 0302 clinical medicine, Hyperpigmentation, Lupus Erythematosus, Systemic, MESH: Contusions, MESH: Iron, MESH: Middle Aged, medicine.diagnostic_test, Middle Aged, MESH: Case-Control Studies, MESH: Hyperpigmentation, 3. Good health, [SDV] Life Sciences [q-bio], MESH: Young Adult, Antirheumatic Agents, Female, medicine.symptom, medicine.drug, Hydroxychloroquine, Adult, medicine.medical_specialty, Contusions, Iron, Dermatology, MESH: Multivariate Analysis, 03 medical and health sciences, Young Adult, Antiphospholipid syndrome, Biopsy, medicine, Humans, MESH: Lupus Erythematosus, Systemic, Retrospective Studies, MESH: Ecchymosis, 030203 arthritis & rheumatology, Lupus erythematosus, MESH: Humans, business.industry, MESH: Time Factors, Case-control study, MESH: Adult, MESH: Retrospective Studies, medicine.disease, MESH: Male, Logistic Models, Case-Control Studies, Multivariate Analysis, sense organs, business, MESH: Female
Abstract

International audience; IMPORTANCE: Hydroxychloroquine-induced pigmentation is not a rare adverse effect. Our data support the hypothesis that hydroxychloroquine-induced pigmentation is secondary to ecchymosis or bruising. OBJECTIVE: To describe the clinical features and outcome of hydroxychloroquine (HCQ)-induced pigmentation in patients with systemic lupus erythematosus (SLE). DESIGN, SETTING, AND PARTICIPANTS: In a case-control study conducted at a French referral center for SLE and antiphospholipid syndrome, 24 patients with SLE, with a diagnosis of HCQ-induced pigmentation, were compared with 517 SLE controls treated with HCQ. MAIN OUTCOMES AND MEASURES: The primary outcome was the clinical features of HCQ-induced pigmentation. Skin biopsies were performed on 5 patients, both in healthy skin and in the pigmented lesions. The statistical associations of HCQ-induced pigmentation with several variables were calculated using univariate and multivariate analyses. RESULTS: Among the 24 patients, skin pigmentation appeared after a median HCQ treatment duration of 6.1 years (range, 3 months-22 years). Twenty-two patients (92%) reported that the appearance of pigmented lesions was preceded by the occurrence of ecchymotic areas, which gave way to a localized blue-gray or brown pigmentation that persisted. Twenty-three patients (96%) had at least 1 condition predisposing them to easy bruising. Results from skin biopsies performed on 5 patients showed that the median concentration of iron was significantly higher in biopsy specimens of pigmented lesions compared with normal skin (4115 vs 413 nmol/g; P

Published
2013
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42. Adherence to treatment in systemic lupus erythematosus patients

Author

Gaëlle Guettrot-Imbert, Jacques Pouchot, Nathalie Costedoat-Chalumeau, Véronique Le Guern, Jean-Charles Piette, Donata Marra, Nathalie Morel, Gaëlle Leroux, Université Paris Descartes - Paris 5 (UPD5), Service de médecine interne et centre de référence des maladies rares [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Médecine Interne [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Centre de référence des syndromes drépanocytaires majeurs, Université de Clermont-Ferrand, Service de Médecine Interne [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Chirurgie Générale, Viscérale et Endocrinienne [CHU Pitié-Sapêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Centre de référence des syndromes drépanocytaires majeurs, Service de Médecine Interne Clermont Ferrand (MéDECINE INTERNE - CLERMONT-FERRAND), Hopital, CHU Pitié-Salpêtrière [APHP], Service de Chirurgie Générale [CHU Pitié-Salpêtrière], and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP]

Subjects
medicine.medical_specialty, MESH: Antirheumatic Agents, MESH: Hydroxychloroquine, MESH: Attitude to Health, Medication adherence, Disease, Therapeutic drug monitoring, Medication Adherence, Poor adherence, 03 medical and health sciences, 0302 clinical medicine, Systemic lupus erythematosus, Rheumatology, MESH: Drug Monitoring, Medicine, Humans, Lupus Erythematosus, Systemic, In patient, MESH: Lupus Erythematosus, Systemic, 030212 general & internal medicine, skin and connective tissue diseases, Intensive care medicine, 030203 arthritis & rheumatology, MESH: Humans, medicine.diagnostic_test, business.industry, Health advice, Hydroxychloroquine, MESH: Medication Adherence, 3. Good health, Adherence, Antirheumatic Agents, Assessment methods, Physical therapy, MESH: Biomarkers, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Drug Monitoring, business, Attitude to Health, Biomarkers, Flare, medicine.drug, Compliance
Abstract

International audience; Adherence is defined as "the extent to which a person's behaviour coincides with medical or health advice." Poor adherence to therapeutic regimens is a common and expensive problem in patients with chronic diseases including systemic lupus erythematosus (SLE) and is associated with a higher risk of flares, morbidity, hospitalisations and poor renal outcome. Non-adherence to the treatment is multifactorial for most patients and varies according to unintentional or intentional patterns. The rates of non-adherence in SLE patients range from 3% to 76% depending on the assessment methods, which are all subject to limitations. Indeed, poor adherence to therapeutic regimens is difficult to evaluate. Two studies have shown that undetectable blood hydroxychloroquine (HCQ) concentration may be a simple, objective and reliable marker of non-adherence in SLE patients. The accurate diagnosis of non-adherence may prevent one from incorrectly interpreting disease manifestations as a lack of response. It may then avoid an unnecessary or even dangerous treatment escalation.

Published
2013
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43. Can remission in rheumatoid arthritis be assessed without laboratory tests or a formal joint count? possible remission criteria based on a self-report RAPID3 score and careful joint examination in the ESPOIR cohort

Author

Bernard Combe, Bruno Fautrel, Isabel Castrejón, Maxime Dougados, Francis Guillemin, Theodore Pincus, Division of Rheumatology (NYU Hospital - Rheumato), New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU)-NYU System (NYU), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Nancy, Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale (INSERM), Rhumatologie, Université Paris Diderot - Paris 7 (UPD7), CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Université de Montpellier (UM)-Université Montpellier 1 (UM1), Division of Rheumatology ( NYU Hospital - Rheumato ), New York University Hospital, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - IURC, Université Montpellier 1 ( UM1 ) -Université de Montpellier ( UM ), Institut de Génétique Moléculaire de Montpellier ( IGMM ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris Diderot - Paris 7 ( UPD7 ), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 ( AIDMP ), and Maladies chroniques, santé perçue, et processus d'adaptation ( APEMAC )

Subjects
Male, MESH: Antirheumatic Agents, MESH: Remission Induction, [SDV]Life Sciences [q-bio], Severity of Illness Index, Arthritis, Rheumatoid, Disability Evaluation, 0302 clinical medicine, Cohen's kappa, Remission criteria, Surveys and Questionnaires, Immunology and Allergy, MESH : Female, 030212 general & internal medicine, MESH : Joints, MESH: Treatment Outcome, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, MESH : Physical Examination, Remission Induction, MESH: Disability Evaluation, MESH : Questionnaires, MESH : Adult, Middle Aged, Joint examination, MESH : Antirheumatic Agents, 3. Good health, MESH: Diagnostic Self Evaluation, MESH: Joints, C-Reactive Protein, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Cohort, MESH : Severity of Illness Index, Female, MESH : Sensitivity and Specificity, Adult, musculoskeletal diseases, medicine.medical_specialty, MESH : Male, Immunology, MESH : Disability Evaluation, MESH : Treatment Outcome, Sensitivity and Specificity, 03 medical and health sciences, Diagnostic Self Evaluation, MESH: Physical Examination, Rheumatology, Internal medicine, MESH: Severity of Illness Index, MESH: C-Reactive Protein, medicine, Humans, MESH : Middle Aged, Physical Examination, 030203 arthritis & rheumatology, MESH : Remission Induction, MESH: Humans, [ SDV ] Life Sciences [q-bio], MESH : Diagnostic Self Evaluation, business.industry, MESH: Questionnaires, MESH : Humans, MESH: Adult, MESH : C-Reactive Protein, medicine.disease, MESH: Sensitivity and Specificity, MESH: Male, MESH : Arthritis, Rheumatoid, Physical therapy, Joints, business, MESH: Female, Rheumatism, Kappa
Abstract

Objective.To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test.Methods.The ESPOIR early RA cohort of 813 French patients recruited in 2002–2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed — Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: “RAPID3R” (RAPID3 ≤ 3.0); “RAPID3R+SJ1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint); “RAPID3R+SJ1+D1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); “RAPID3R+SJ0” (RAPID3 ≤ 3.0, 0 swollen joints); and “RAPID3R+SJ0+D1” (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed.Results.Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%–94.7%, kappa 0.67–0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%–85.8%, kappa 0.46–0.55).Conclusion.Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.

Published
2013
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44. EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria

Author

Tore K Kvien, David T. Felson, Cédric Lukas, Ewa Stanislawska-Biernat, Josef S Smolen, Robert Landewé, Alan J. Silman, Paul Emery, Bernard Combe, Maxime Dougados, Daniel Aletaha, Angela Zink, Désirée van der Heijde, Iain B. McInnes, Clifton O. Bingham, Annette H M van der Helm-van Mil, Rachel Knevel, Gerd Burmester, Department of Rheumatology, Leiden University Medical Center (LUMC), University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC), Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin / Charite - University Medicine Berlin, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), University of Leeds, Tufts University School of Medicine [Boston], Diakonhjemmet Hospital, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, ARC Epidemiology Unit, The University of Manchester, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Centre d'Investigation Clinique INSERM 1412 (CIC 1412 - BREST), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), The University of North Carolina at Chapel Hill, Charité - University Medicine, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ), Service de Rhumatologie [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP), Academic Medical Center [Amsterdam] ( AMC ), University of Amsterdam [Amsterdam] ( UvA ), Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ) -Hôpital Lapeyronie, Centre d'Investigation Clinique INSERM 1412 ( CIC 1412 - BREST ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Lymphocyte B et Auto-immunité ( LBAI ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and CHRU Brest - Service de Rhumatologie ( CHU - BREST - Rhumato )

Subjects
musculoskeletal diseases, medicine.medical_specialty, MESH: Antirheumatic Agents, Inflammatory arthritis, [SDV]Life Sciences [q-bio], Immunology, MESH : Europe, Arthritis, Metatarsophalangeal joints, Context (language use), General Biochemistry, Genetics and Molecular Biology, Arthritis, Rheumatoid, [ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatology, Internal medicine, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, MESH: Rheumatology, medicine, Humans, Immunology and Allergy, skin and connective tissue diseases, MESH : Rheumatology, MESH : Joints, MESH : Evidence-Based Medicine, MESH: Arthritis, Rheumatoid, Evidence-Based Medicine, MESH: Humans, [ SDV ] Life Sciences [q-bio], business.industry, MESH : Humans, medicine.disease, MESH : Antirheumatic Agents, Europe, MESH: Joints, medicine.anatomical_structure, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Rheumatoid arthritis, Cohort, MESH : Arthritis, Rheumatoid, Physical therapy, Joints, MESH: Europe, business, Rheumatism, MESH: Evidence-Based Medicine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; The aim of this report was to propose a definition for erosive disease in the context of inflammatory arthritis in light of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) criteria for use in clinical practice and studies. A EULAR task force was formed including 16 rheumatologists and one rheumatology fellow. The process was both evidence based and consensus based, and included, between March 2010 and April 2012, analyses of data from two cohorts, two face-to-face meetings, one online voting and one teleconference. The Leiden Early Arthritis Cohort and the French ESPOIR cohort were used for the evidence-based part. The outcome measures, which were initiation of methotrexate therapy, or any disease-modifying antirheumatic drug therapy within the first year of disease and arthritis persistency over 5 years, were studied with the aim to give the best definition of erosive disease. A decision was made to select a definition with a high specificity and focus on patients who did not otherwise fulfil the 2010 ACR/EULAR RA criteria (

Published
2013

45. Effect of adherence to European treatment recommendations on early arthritis outcome: data from the ESPOIR cohort

Author

Bruno Fautrel, Cécile Escalas, Bernard Combe, Philippe Ravaud, Pierre Durieux, Marie Dalichampt, Francis Guillemin, Maxime Dougados, Institut de Génétique Moléculaire de Montpellier ( IGMM ), Centre National de la Recherche Scientifique ( CNRS ) -Université de Montpellier ( UM ), Rhumatologie, Université Paris Diderot - Paris 7 ( UPD7 ), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Nancy, Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Maladies chroniques, santé perçue, et processus d'adaptation ( APEMAC ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Centre de Recherche des Cordeliers ( CRC (UMR_S 872) ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Service de rhumatologie [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Immunologie et Pathologie ( EA2216 ), Université de Brest ( UBO ) -IFR148, CHRU Brest - Service de Rhumatologie ( CHU - BREST - Rhumato ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Centre d'Investigation Clinique ( CIC - Brest ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Université Paris Diderot - Paris 7 (UPD7), Cancéropôle du Grand Est-Institut National de la Santé et de la Recherche Médicale (INSERM), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Centre de Recherche des Cordeliers (CRC (UMR_S 872)), Université Paris Descartes - Paris 5 (UPD5)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), and Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]

Subjects
Male, MESH: Antirheumatic Agents, MESH : Prospective Studies, MESH: Logistic Models, MESH : Arthrography, 0302 clinical medicine, MESH: Practice Guidelines as Topic, Epidemiology, Clinical endpoint, MESH: Arthrography, Immunology and Allergy, MESH : Female, 030212 general & internal medicine, Prospective Studies, Arthrography, MESH : Propensity Score, MESH : Joints, MESH: Treatment Outcome, education.field_of_study, MESH: Middle Aged, MESH : Prognosis, Middle Aged, Prognosis, MESH: Patient Compliance, MESH : Antirheumatic Agents, 3. Good health, MESH: Joints, MESH : Practice Guidelines as Topic, Treatment Outcome, Antirheumatic Agents, Cohort, Practice Guidelines as Topic, Disease Progression, Female, MESH: Disease Progression, Cohort study, medicine.medical_specialty, MESH : Male, Immunology, Population, MESH: Arthritis, MESH : Treatment Outcome, General Biochemistry, Genetics and Molecular Biology, MESH: Prognosis, MESH : Patient Compliance, 03 medical and health sciences, Rheumatology, Internal medicine, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, medicine, Humans, MESH : Middle Aged, education, Propensity Score, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Arthritis, MESH : Humans, MESH : Arthritis, MESH : Disease Progression, MESH: Propensity Score, medicine.disease, MESH: Prospective Studies, MESH: Male, Logistic Models, Propensity score matching, Physical therapy, Patient Compliance, Observational study, Joints, business, MESH: Female, Rheumatism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, MESH : Logistic Models
Abstract

ObjectiveTo assess the association of adherence to the 2007 recommendations of the European League Against Rheumatism (EULAR) for managing early arthritis and radiographic progression and disability in patientsMethodsThe authors conducted a prospective population-based cohort study. The ESPOIR cohort was a French cohort of 813 patients with early arthritis not receiving disease-modifying antirheumatic drugs (DMARDs). Adherence to the 2007 EULAR recommendations was defined by measuring adherence to three of the recommendations concerning the initiation and early adjustment of DMARDs. The study endpoints were radiographic progression, defined as the presence of at least one new erosion between baseline and 1 year, and disability as a heath assessment questionnaire score ≥1 at 2 years. A propensity score of being treated according to the recommendations was developed.ResultsAfter adjustment for propensity score, treatment centre and the main confounding factors, patients without recommendation adherence were at increased risk of radiographic progression at 1 year, and of functional impairment at 2 years (OR 1.98, (95% CI: 1.08 to 3.62 and OR: 2.36, (95% CI: 1.17 to 4.67), respectively).ConclusionsEarly arthritis patients whose treatment adhered to the 2007 EULAR recommendations seemed to benefit from such treatment in terms of risk of clinical and radiographic progression. Using a propensity score of being treated according to recommendations in observational studies may be useful in assessing the potential impact of these recommendations on outcome.

Published
2012
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46. Evidence of the symptomatic and structural efficacy of methotrexate in daily practice as the first disease-modifying drug in rheumatoid arthritis despite its suboptimal use: results from the ESPOIR early synovitis cohort

Author

Gaujoux-Viala, Cécile, Paternotte, Simon, Combe, Bernard, Dougados, Maxime, Saraux, Alain, Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Institut de Génétique Moléculaire de Montpellier ( IGMM ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], Immunologie et Pathologie ( EA2216 ), Université de Brest ( UBO ) -IFR148, CHRU Brest - Service de Rhumatologie ( CHU - BREST - Rhumato ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Centre d'Investigation Clinique ( CIC - Brest ), and Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM )

Subjects
Male, MESH: Antirheumatic Agents, MESH: Synovitis, Health Status, MESH : Aged, Arthritis, MESH : Dose-Response Relationship, Drug, Severity of Illness Index, Gastroenterology, MESH: Dose-Response Relationship, Drug, Arthritis, Rheumatoid, Cohort Studies, 0302 clinical medicine, Outcome Assessment, Health Care, Pharmacology (medical), MESH : Female, 030212 general & internal medicine, skin and connective tissue diseases, MESH: Cohort Studies, MESH: Health Status, media_common, MESH: Treatment Outcome, MESH : Synovitis, MESH: Aged, MESH: Arthritis, Rheumatoid, Synovitis, MESH: Middle Aged, Middle Aged, MESH : Adult, MESH : Antirheumatic Agents, 3. Good health, Treatment Outcome, MESH: Methotrexate, MESH: Young Adult, Antirheumatic Agents, Rheumatoid arthritis, Cohort, Disease Progression, Drug Therapy, Combination, Female, MESH : Severity of Illness Index, MESH: Disease Progression, medicine.drug, Adult, Drug, musculoskeletal diseases, medicine.medical_specialty, Adolescent, MESH : Outcome Assessment (Health Care), media_common.quotation_subject, MESH : Male, MESH : Young Adult, MESH : Cohort Studies, MESH : Treatment Outcome, MESH: Folic Acid, Young Adult, 03 medical and health sciences, Folic Acid, Rheumatology, Internal medicine, MESH : Adolescent, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, MESH: Severity of Illness Index, medicine, Humans, MESH : Middle Aged, MESH : Health Status, MESH: Outcome Assessment (Health Care), Aged, 030203 arthritis & rheumatology, MESH: Adolescent, MESH : Folic Acid, MESH: Humans, Dose-Response Relationship, Drug, business.industry, MESH : Drug Therapy, Combination, MESH : Humans, MESH: Adult, MESH : Disease Progression, medicine.disease, MESH: Male, Surgery, MESH: Drug Therapy, Combination, Methotrexate, Concomitant, MESH : Methotrexate, Propensity score matching, MESH : Arthritis, Rheumatoid, business, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; OBJECTIVE: To describe the use of MTX in early arthritis (EA) in daily clinical practice and to evaluate its 6-month symptomatic efficacy and 12-month structural efficacy. METHODS: Patients included in the French observational ESPOIR cohort were assessed. Evaluation of the symptomatic and structural efficacy was performed by generalized linear regression after adjustment on propensity score (PS) in the group of patients receiving at least 3 months of MTX vs the ones receiving any other treatment except LEF, SSZ or TNF inhibitors. RESULTS: Within the first 6 months of follow-up of 777 EA patients, 59% received a DMARD, which was MTX in 68% (N = 313) of patients. The mean dose of MTX was 12.7 ± 3.8 mg/week. Only 53.7% of the patients received folic acid supplementation. MTX was initiated in patients with more active and severe disease. At 6 months, in unadjusted analysis, patients starting MTX had a significantly higher DAS-28 (3.58 vs 3.23; P = 0.001) and a significantly higher HAQ (0.60 vs. 0.48; P = 0.01) compared with controls. After adjustment by PS, there were no significant differences. Adjustment for the PS also revealed a statistically significant decrease in the radiological progression at 12 months in the MTX group [total Sharp-van der Heijde score (SHS), 1.05 ± 0.29 vs 2.02 ± 0.29, P = 0.025]. CONCLUSION: This study confirms the symptomatic and structural efficacy of MTX in EA in daily practice despite the non-optimal use of MTX, including low doses and infrequent concomitant folic acid supplementation.

Published
2012
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47. Anakinra treatment of SAPHO syndrome: short-term results of an open study

Author

Clément Prati, François Aubin, Daniel Wendling, Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz, Agents pathogènes et inflammation - UFC (EA 4266) ( API ), Université de Franche-Comté ( UFC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), and Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC )

Subjects
SAPHO syndrome, medicine.medical_specialty, Hyperostosis, Pathology, Acquired Hyperostosis Syndrome, MESH: Antirheumatic Agents, MESH : Male, Immunology, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, General Biochemistry, Genetics and Molecular Biology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Synovitis, MESH : Interleukin 1 Receptor Antagonist Protein, medicine, Immunology and Allergy, MESH : Female, MESH : Middle Aged, MESH : Acquired Hyperostosis Syndrome, ComputingMilieux_MISCELLANEOUS, MESH: Treatment Outcome, 030203 arthritis & rheumatology, Anakinra, MESH: Acquired Hyperostosis Syndrome, MESH: Humans, MESH: Middle Aged, business.industry, MESH : Humans, MESH: Adult, MESH : Adult, medicine.disease, Periostitis, Pustulosis, Dermatology, MESH : Antirheumatic Agents, MESH: Male, 3. Good health, MESH: Interleukin 1 Receptor Antagonist Protein, Osteitis, medicine.symptom, business, MESH: Female, medicine.drug
Abstract

SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome comprises many features, but has no specific treatment.1 2 According to the target symptom (synovitis, skin, bone) non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDs), bisphosphonates3 and tumour necrosis factor (TNF) blockers4 may be proposed, but with variable results. Some patients do not exhibit improvement of symptoms despite use of several, sometimes combined, lines of treatment. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist has recently been described5 under the name DIRA. It associates sterile multifocal osteomyelitis, periostitis and pustulosis, which looks like SAPHO, with good response to anakinra, an interleukin 1 (IL-1) receptor antagonist. We describe the …

Published
2012
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48. Favorable effect of very early disease-modifying antirheumatic drug treatment on radiographic progression in early inflammatory arthritis: Data from the Étude et Suivi des polyarthrites indifférenciées récentes (study and followup of early undifferentiated polyarthritis)

Author

Lukas, C., Combe, B., Ravaud, P., Sibilia, J., Landew, R., Van Der Heijde, D., Saraux, Alain, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie des arthrites, Université Louis Pasteur - Strasbourg I, Department of Rheumatology, University Hospital Maastricht, Leiden University Medical Center (LUMC), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Interne Geneeskunde, RS: CAPHRI School for Public Health and Primary Care, AII - Amsterdam institute for Infection and Immunity, and Clinical Immunology and Rheumatology

Subjects
Male, Wrist Joint, MESH: Antirheumatic Agents, Inflammatory arthritis, [SDV]Life Sciences [q-bio], MESH: Wrist Joint, Arthritis, MESH: Logistic Models, Severity of Illness Index, Arthritis, Rheumatoid, 0302 clinical medicine, Immunology and Allergy, Pharmacology (medical), MESH: Treatment Outcome, MESH: Statistics, Nonparametric, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Early Inflammatory Arthritis, Middle Aged, 3. Good health, Treatment Outcome, Antirheumatic Agents, Cohort, Disease Progression, Female, Polyarthritis, MESH: Disease Progression, Adult, musculoskeletal diseases, medicine.medical_specialty, Immunology, early rheumatoid-arthritis combination therapy eular recommendations american-college joint damage methotrexate trial classification metaanalysis management, Statistics, Nonparametric, MESH: Foot, MESH: Hand, 03 medical and health sciences, Rheumatology, Internal medicine, MESH: Severity of Illness Index, Severity of illness, medicine, Humans, 030203 arthritis & rheumatology, MESH: Humans, Foot, business.industry, MESH: Adult, Hand, medicine.disease, MESH: Male, Surgery, Radiography, Logistic Models, Propensity score matching, Observational study, business, MESH: Female, 030215 immunology
Abstract

International audience; OBJECTIVE: While there is consensus that treatment with disease-modifying antirheumatic drugs (DMARDs) should be started early in patients with inflammatory arthritis, confirmation that radiographic progression is inhibited with early treatment start is scarce. This study was undertaken to compare radiographic progression in patients treated with a DMARD very early in the course of their disease (within 3 months of diagnosis) and those who began DMARD treatment later. METHODS: Patients included in the French observational ESPOIR (Étude et Suivi des Polyarthrites Indifférenciées Récentes [Study and Followup of Early Undifferentiated Polyarthritis]) cohort were followed up, and radiographic progression after 12 months was assessed. Propensity scores, reflecting the indication to start a DMARD, were obtained by modeling the start of DMARD therapy by disease-specific and demographic variables obtained at baseline, using logistic regression analysis. The influence of very early versus delayed DMARD start on radiographic progression was evaluated by generalized linear regression, with and without adjustment for propensity scores. RESULTS: Six hundred sixty-one patients were analyzed. In an unadjusted analysis, patients starting DMARD therapy within 3 months of diagnosis did not show a significant difference in radiographic progression score as compared to those starting DMARD therapy later (1.2 units versus 1.6 units; P = 0.37). Adjustment for the propensity score revealed a statistically significant difference in mean progression (0.8 units versus 1.7 units; P = 0.033). Analysis by propensity score quintile showed a trend suggesting that early treatment was especially beneficial for patients in the fourth and fifth quintiles (worse prognosis). CONCLUSION: Our findings indicate that among patients with inflammatory arthritis in daily clinical practice, early initiation of DMARD therapy reduces 12-month radiographic progression. This strengthens the current recommendations for very early initiation of specific therapy in patients with early arthritis.

Published
2011
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49. Diagnostic accuracy of ACR/EULAR 2010 criteria for rheumatoid arthritis in a 2-year cohort

Author

Sophie Varache, Divi Cornec, Alain Saraux, Pierre Youinou, Jean-Baptiste Thorel, Valérie Devauchelle-Pensec, Gérard Chalès, Sandrine Jousse-Joulin, Emmanuel Nowak, Johanne Morvan, Catherine Le Henaff-Bourhis, Sylvie Hoang, Antoine Martin, Jean-Marie Berthelot, CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), Pôle Ostéoarticulaire, Centre hospitalier universitaire de Nantes (CHU Nantes), Service d'Anatomie et de Cytologie Pathologiques [Avicenne], Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service de rhumatologie [Rennes] = Rheumatology [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire, Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris 13 (UP13), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )

Subjects
MESH: Antirheumatic Agents, Arthritis, Arthritis, Rheumatoid, Cohort Studies, 0302 clinical medicine, Immunology and Allergy, Longitudinal Studies, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, skin and connective tissue diseases, MESH: Longitudinal Studies, MESH: Cohort Studies, Societies, Medical, MESH: Arthritis, Rheumatoid, MESH: Follow-Up Studies, MESH: Predictive Value of Tests, Europe, Antirheumatic Agents, Predictive value of tests, Rheumatoid arthritis, Cohort, Algorithms, Cohort study, musculoskeletal diseases, medicine.medical_specialty, Immunology, MESH: Societies, Medical, MESH: Algorithms, Sensitivity and Specificity, 03 medical and health sciences, Rheumatology, Predictive Value of Tests, Internal medicine, MESH: Rheumatology, medicine, MESH: United States, Humans, 030203 arthritis & rheumatology, MESH: Humans, business.industry, medicine.disease, United States, MESH: Sensitivity and Specificity, MESH: Prospective Studies, MESH: Europe, Nuclear medicine, business, Rheumatism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

Objective.To evaluate the diagnostic accuracy of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and 1987 ACR criteria for rheumatoid arthritis (RA), and the respective role of the algorithm and scoring of the ACR/EULAR.Methods.In total, 270 patients with recent-onset arthritis of < 1 year duration were included prospectively between 1995 and 1997 and followed for 2 years. RA was defined as the combination, at completion of followup, of RA diagnosed by an office-based rheumatologist and treatment with a disease-modifying antirheumatic drug or glucocorticoid. We compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the criteria sets in the overall population, in the subgroup meeting the tree condition for ACR/EULAR scoring, and in the overall population classified according the full tree.Results.At baseline, 111 of the 270 patients had better alternative diagnoses and 16 had erosions typical for RA; of the 143 remaining patients, 52 had more than 6 ACR/EULAR 2010 points (indicating definite RA) and 91 had fewer than 6 points. After 2 years, 11/16 patients with erosions and 40/52 with more than 6 points had RA. 100 of the 270 patients met the reference standard for RA. Sensitivity, specificity, PPV, and NPV of the ACR/EULAR (full tree) were 51/100 (51%), 153/170 (90%), 51/68 (75.4%), and 153/202 (75.7%), respectively. Diagnostic accuracies of the ACR/EULAR score and ACR 1987 criteria were not statistically different.Conclusion.Much of the improvement of the ACR/EULAR criteria was ascribable to the use of exclusion criteria in the algorithm.

Published
2011
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50. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate

Author

Genovese, C., Covarrubias, A., Leon, G, Mysler, E, Keiserman, M, Valente, R, Nash, P, Simon-Campos, J, Porawska, W., Box, J, Legerton, C, Nasonov, E, Durez, P, Aranda, R, Pappu, R, Delaet, I, Teng, J, Alten, R, Genovese, P, Covarrubias, C, Porawska, P, Saraux, Alain, Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, Centro Medico de Las Americas (CM Las Americas), Centro Medico De Las Americas, Instituto De Ginecologia Y Reproduccion, Organizacion Medica de Investigacion, Organizacion Medica de Investigacion (OMI BUENOS AIRES), Pontifical Catholic University School of Medicine (PCUSM PORTO ALEGRE), Pontificial Catholic University School of Medicine, Physician Research Collaboration (PRC - LINCOLN), Physician Research Collaboration, The University of Queensland, University of Queensland [Brisbane], Centro de Especialidades Medicas (CEM - MERIDA), Centro de Especialidades Medicas, Poznanski Osrodek Medyczny Novamed (POMN - POZNAN), Poznanski Osrodek Medyczny Novamed, Box Arthritis and Rheumatology (BAR - CHARLOTTE), Box Arthritis and Rheumatology, Université Catholique de Louvain = Catholic University of Louvain (UCL), National Institute of Metrology [Beijing], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), and Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)

Subjects
Male, MESH: Antirheumatic Agents, Immunoconjugates, [SDV]Life Sciences [q-bio], Gastroenterology, Arthritis, Rheumatoid, MESH: Immunoconjugates, Immunology and Allergy, Pharmacology (medical), MESH: Double-Blind Method, MESH: Treatment Outcome, MESH: Aged, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Middle Aged, MESH: Methotrexate, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Injections, Intravenous, Female, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, Injections, Subcutaneous, Immunology, Rheumatoid Arthritis, Placebo, Loading dose, Abatacept, Route of administration, Rheumatology, Double-Blind Method, Internal medicine, medicine, Humans, MESH: Abatacept, Adverse effect, Aged, MESH: Humans, business.industry, MESH: Injections, Subcutaneous, MESH: Adult, medicine.disease, MESH: Injections, Intravenous, Confidence interval, MESH: Male, Surgery, Methotrexate, business, MESH: Female
Abstract

Objective To compare the efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept. Methods In this phase IIIb double-blind, double-dummy, 6-month study, patients with rheumatoid arthritis (RA) and inadequate responses to methotrexate were randomized to receive 125 mg SC abatacept on days 1 and 8 and weekly thereafter (plus an IV loading dose [∼10 mg/kg] on day 1) or IV abatacept (∼10 mg/kg) on days 1, 15, and 29 and every 4 weeks thereafter. The primary end point for determining the noninferiority of SC abatacept to IV abatacept was the proportion of patients in each group meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at month 6. Other efficacy end points, immunogenicity, and safety were also assessed. Results Of 1,457 patients, 693 of 736 (94.2%) treated with SC abatacept and 676 of 721 (93.8%) treated with IV abatacept completed 6 months. At month 6, 76.0% (95% confidence interval 72.9, 79.2) of SC abatacept–treated patients versus 75.8% (95% confidence interval 72.6, 79.0) of IV abatacept–treated patients achieved an ACR20 response (estimated difference between groups 0.3% [95% confidence interval –4.2, 4.8]), confirming noninferiority of SC abatacept to IV abatacept. Onset and magnitude of ACR responses and disease activity and physical function improvements were comparable between the SC and IV abatacept–treated groups. The proportions of adverse events (AEs) and serious AEs over 6 months were 67.0% and 4.2%, respectively, in the SC abatacept–treated group and 65.2% and 4.9%, respectively, in the IV abatacept–treated group, with comparable frequencies of serious infections, malignancies, and autoimmune events between groups. SC injection site reactions (mostly mild) occurred in 19 SC abatacept (IV placebo)–treated patients (2.6%) and 18 IV abatacept (SC placebo)–treated patients (2.5%). Abatacept-induced antibodies occurred in 1.1% of SC abatacept–treated patients and 2.3% of IV abatacept–treated patients. Conclusion SC abatacept provides efficacy and safety comparable with that of IV abatacept, with low immunogenicity and high retention rates, consistent with the established IV abatacept profile. Rates of injection site reactions were low. SC abatacept will provide additional treatment options, such as an alternative route of administration, for patients with RA.

Published
2011

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