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1. Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis

Author: Amsterdam Rheumatology and Immunology Center and michal roll, Research and Developemnt, Head
Published: 2018

2. T Lymphocyte Clonal Alterations in Anti-Citrullinated Protein Antibody Positive Synovitis

Author: Cantaert, Tineke, Brouard, Sophie, Braud, Cristophe, Soulillou, Jean-Paul, de Vries, Niek, Tak, Paul-Peter, and Baeten, Dominique
Published: 2007
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3. Synovial T/B Cell Lymphoid Aggregates Regulate the Production of Rheumatoid Arthritis-specific Autoantibodies

Author: Cantaert, Tineke, Timmer, Trieneke, Vandooren, Bernard, Wijbrandts, Carla, Thurlings, Rogier, De Rycke, Leen, van der Pouw-Kraan, Tineke, Out, Theo, Tak, Paul-Peter, and Baeten, Dominique
Published: 2007
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4. Non-pathogenic antinuclear antibodies contribute to the clearance of apoptotic antigens released during TNFα blockade in spondyloarthritis (SpA)

Author: Cantaert, Tineke, De Rycke, Leen, Vandooren, Bernard, Wijbrandts, Carla, Kruithof, Elli, De Keyser, Filip, Veys, Eric M., Tak, Paul-Peter, and Baeten, Dominique
Published: 2007
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5. BOB.1 controls memory B-cell fate in the germinal center reaction

Author: Dominique Baeten, Lisa G. M. van Baarsen, Sophie Brouard, Maartje J. Levels, Tom O'Toole, Nataliya Yeremenko, Arjen Q. Bakker, Mikhail Krasavin, Cynthia M. Fehres, JF Semmelink, Iris C Blijdorp, Alexey Tomilin, Marieke E. Doorenspleet, Kristine Germar, Nathalie O. P. van Uden, Hergen Spits, Department of Rheumatology & Clinical Immunology [Amsterdam, the Netherlands] (Amsterdam UMC), University of Amsterdam [Amsterdam] (UvA)-Amsterdam Infection & Immunity Institute [Amsterdam, the Netherlands], Department of Experimental Immunology [Amsterdam, the Netherlands] (Amsterdam UMC), Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), Amsterdam Infection & Immunity Institute [Amsterdam, the Netherlands] (Amsterdam UMC), Vrije Universiteit Amsterdam [Amsterdam] (VU), AIMM Therapeutics [Amsterdam, the Netherlands], Saint Petersburg State University [Saint Petersburg, Russian Federation], Institute of Cytology and Genetics, Russian Academy of Sciences [Moscow] (RAS), Immunoregulation And Immunointervention in Transplantation and Autoimmunity (Team 4 - U1064 Inserm - CRTI), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Clinical Immunology and Rheumatology, Graduate School, AII - Inflammatory diseases, 01 Internal and external specialisms, Dermatology, Experimental Immunology, AGEM - Digestive immunity, Le Bihan, Sylvie, and Molecular cell biology and Immunology
Subjects: Memory B cell, 0301 basic medicine, T-Lymphocytes, Plasma Cells, Immunology, Naive B cell, Gene Expression, Receptors, Antigen, B-Cell, Plasma cell, Biology, medicine.disease_cause, Cell Line, Mice, 03 medical and health sciences, 0302 clinical medicine, Immune system, Autoimmune disease, medicine, Animals, Humans, Immunology and Allergy, BOB.1, Rheumatoid arthritis, B cell, Mice, Knockout, 030203 arthritis & rheumatology, B-Lymphocytes, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Germinal center, Immune dysregulation, BCL6, 030104 developmental biology, medicine.anatomical_structure, Trans-Activators, Lymph Nodes, Rheumatic Fever, Immunologic Memory, Biomarkers, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; During T cell-dependent (TD) germinal center (GC) responses, naïve B cells are instructed to differentiate towards GC B cells (GCBC), high-affinity long-lived plasma cells (LLPC) or memory B cells (Bmem). Alterations in the B cell-fate choice could contribute to immune dysregulation leading to the loss of self-tolerance and the initiation of autoimmune disease. Here we show that mRNA levels of the transcription regulator BOB.1 are increased in the lymph node compartment of patients with rheumatoid arthritis (RA), a prototypical auto-immune disease caused by the loss of immunological tolerance. Investigating to what extent levels of BOB.1 impact B cells during TD immune responses we found that BOB.1 has a crucial role in determining the B cell-fate decision. High BOB.1 levels promote the generation of cells with phenotypic and functional characteristics of Bmem. Mechanistically, overexpression of BOB.1 drives ABF1 and suppresses BCL6, favouring Bmem over LLPC or recycling GCBC. Low levels of BOB.1 are sufficient for LLPC but not for Bmem differentiation. Our findings demonstrate a novel role for BOB.1 in B cells during TD GC responses and suggest that its dysregulation may contribute to the pathogenesis of RA by disturbing the B cell-fate determination.
Published: 2019

6. Development of ASAS quality standards to improve the quality of health and care services for patients with axial spondyloarthritis

Author: J. Brandt, Pedro Machado, Karin Niederman, Uta Kiltz, Victoria Navarro-Compán, Juergen Braun, Laure Gossec, Salima van Weely, Dieter Wiek, Robert Landewé, Michael H. Weisman, Maxime Dougados, Merryn Jongkees, Philippe Carron, Helena Marzo-Ortega, Gleb Slobodin, Annelies Boonen, Percival D. Sampaio-Barros, Anna Molto, Nurullah Akkoc, Désirée van der Heijde, Filip Van den Bosch, Martin Rudwaleit, Astrid van Tubergen, Interne Geneeskunde, MUMC+: MA Reumatologie (9), RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Rheumatology, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, 44801, Germany, Amsterdam Rheumatology Center, AMC, Amsterdam, Netherlands, Rheumatology, Zuyderland MC, Heerlen, Netherlands, Rheumatology, Leiden University Medical Center, Leiden, Netherlands, Internal Medicine and Rheumatology, Klinikum Bielefeld Rosenhöhe, Bielefeld, Germany, Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, Los Angeles, CA, United States, Department of Medicine, Division of Rheumatology, Celal Bayar University School of Medicine, Manisa, Turkey, Internal Medicine, Division of Rheumatology, Maastrich University Medical Center, Maastricht, Netherlands, Care and Public Health Research Institute (CAPHRI), Maastricht, Netherlands, Rheumatology, Private Practice, Berlin, Germany, Rheumatology, Ghent University Hospital, Ghent, Belgium, VIB Inflammation Research Center, Ghent, Belgium, Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France, INSERM (U1153): Epidémiologie Clinique et Biostatistiques, PRES Sorbonne Paris-Cité, Paris, France, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), UMR S 1136, Sorbonne Universite, Paris, France, APHP, Rheumatology Department, Hopital Universitaire Pitie Salpetriere, Paris, France, Patient Research Partner, Amsterdam, Netherlands, MRC Centre for Neuromuscular Diseases, University College London, London, United Kingdom, Rheumatology, University College London Centre for Rheumatology, London, United Kingdom, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Disease, University of Leeds, Faculty of Medicine and Health, Leeds, United Kingdom, Rheumatology, Hopital Cochin, Paris, France, Department of Rheumatology, University Hospital la Paz, IdiPaz, Madrid, Spain, School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences, Winterthur, Switzerland, Faculdade de Medicina, Universidade de São Paulo, Hospital das Clínicas, Sao Paulo, Brazil, Department of Internal Medicine A, Bnai Zion Medical Center, Technion, Haifa, Israel, Department of Internal Medicine and Pediatrics, Ghent University, Faculty of Medicine and Health Sciences, Gent, Belgium, Reade, Centre for Rehabilitation and Rheumatology, Amsterdam, Netherlands, Patient Research Partner, Huenxe, Germany, Clinical Immunology and Rheumatology, and AII - Inflammatory diseases
Subjects: Adult, Male, INDICATORS, Sondyloarthritis, medicine.medical_specialty, Consensus, Quality management, Referral, INFLAMMATORY ARTHRITIS, media_common.quotation_subject, Advisory Committees, Immunology, Qality Indicators, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Spondylarthritis, ankylosing spondylitis, Health care, Medicine and Health Sciences, medicine, Humans, quality Indicators, Immunology and Allergy, Quality (business), 030212 general & internal medicine, Axial spondyloarthritis, Societies, Medical, media_common, 030203 arthritis & rheumatology, Community level, Adult patients, business.industry, Biology and Life Sciences, OUTCOME MEASURES, spondyloarthritis, Quality Improvement, RHEUMATOID-ARTHRITIS, Family medicine, OF-CARE, DELAY, 616.7: Krankheiten des Bewegungsapparates und Orthopädie, Female, business, Delivery of Health Care, Stepwise approach
Abstract: ObjectivesThe Assessment of SpondyloArthritis International Society (ASAS) aimed to develop a set of quality standards (QS) to help improve the quality of healthcare provided to adult patients affected by axial spondyloarthritis (axSpA) worldwide.MethodsAn ASAS task force developed a set of QS using a stepwise approach. First, key areas for quality improvement were identified, discussed, rated and agreed on. Thereafter, areas were prioritised and statements for the most important key areas were phrased on consensus. Appropriate quality measures were defined to allow quantification of the QS at the community level.ResultsThe ASAS task force, consisting of 20 rheumatologists, two physiotherapists and two patients, selected and proposed 34 potential key areas for quality improvement which were then commented by 140 ASAS members and patients. Within that process three new key areas came up, which led to a re-evaluation of all 37 key areas by 120 ASAS members and patients. Five key areas were identified as most important to determine quality of care: referral including rapid access, rheumatology assessment, treatment, education/self-management and comorbidities. Finally, nine QS were agreed on and endorsed by the whole ASAS membership.ConclusionsASAS successfully developed the first set of QS to help improving healthcare for adult patients with axSpA. Even though it may currently not be realistic to achieve the QS in all healthcare systems, they provide high-quality of care framework for patients with axSpA that should be aimed for.
Published: 2020

7. How do clinical and socioeconomic factors impact on work disability in early axial spondyloarthritis? Five-year data from the DESIR cohort

Author: Elena Nikiphorou, Bruno Fautrel, Pascal Richette, Robert Landewé, Annelies Boonen, Sofia Ramiro, Désirée van der Heijde, King‘s College London, Leiden University Medical Center (LUMC), King's College Hospital (KCH), Maastricht University [Maastricht], Service de Rhumatologie [CHU Pitié Salpêtrière], 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), Pharmacoépidémiologie et évaluation des soins [iPLesp] (PEPITES), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Biologie de l'Os et du Cartilage : Régulations et Ciblages Thérapeutiques (BIOSCAR (UMR_S_1132 / U1132)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Zuyderland Hospital [Heerlen, The Netherlands], Gestionnaire, Hal Sorbonne Université, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, MUMC+: MA Reumatologie (9), Clinical Immunology and Rheumatology, and AII - Inflammatory diseases
Subjects: work disability, medicine.medical_specialty, [SDV]Life Sciences [q-bio], socioeconomic factors, Severity of Illness Index, Cohort Studies, Rheumatology, QUALITY-OF-LIFE, Internal medicine, Spondylarthritis, medicine, Humans, axSpA, Spondylitis, Ankylosing, Pharmacology (medical), Axial spondyloarthritis, Socioeconomic status, Ankylosing spondylitis, PRODUCTIVITY, adverse work outcomes, Work disability, business.industry, Incidence (epidemiology), Desir cohort, ANKYLOSING-SPONDYLITIS, medicine.disease, [SDV] Life Sciences [q-bio], Cohort, FOLLOW-UP, business, BASFI, disease activity, Axial Spondyloarthritis
Abstract: Objectives To investigate the impact of clinical and socioeconomic factors on work disability (WD) in early axial spondyloarthritis (axSpA). Methods Patients from the DESIR cohort with a clinical diagnosis of axSpA were studied over 5 years. Time to WD and potential baseline and time-varying predictors were explored, with a focus on socioeconomic (including ethnicity, education, job-type, marital/parental status) and clinical (including disease activity, function, mobility) factors. Univariable analyses, collinearity and interaction tests guided subsequent multivariable time-varying Cox survival analyses. Results From 704 patients eligible for this study, the estimated incidence of WD among those identified as at risk (n = 663, 94%), and across the five years of DESIR, was 0.05 (95% CI 0.03, 0.06) per 1000 person-days. Significant differences in baseline socioeconomic factors, including lower educational status and clinical measures, including worse disease activity, were seen in patients developing WD over follow-up, compared with those who never did. In the main multivariable model, educational status was no longer predictive of WD, whereas the AS disease activity score (ASDAS) and the BASFI were significantly and independently associated with a higher hazard of WD [HR (95%CI) 1.79 (1.27, 2.54) and 1.42 (1.22, 1.65), respectively]. Conclusion WD was an infrequent event in this early axSpA cohort. Nevertheless, clinical factors were among the strongest predictors of WD, over socioeconomic factors, with worse disease activity and function independently associated with a higher hazard of WD. Disease severity remains a strong predictor of adverse work outcome even in early disease, despite substantial advances in therapeutic strategies in axSpA.
Published: 2021

8. Gender Equity in Academic Rheumatology, Current Status and Potential for Improvement: A Cross-Sectional Study to Inform an EULAR Task Force

Author: Pavel V Ovseiko, Laure Gossec, Laura Andreoli, Uta Kiltz, Leonieke van Mens, Neelam Hassan, Marike van der Leeden, Heidi J Siddle, Alessia Alunno, Iain B McInnes, Nemanja S Damjanov, Florence Apparailly, Caroline Ospelt, Irene E van der Horst-Bruinsma, Elena Nikiphorou, Katie L Druce, Zoltán Szekanecz, Alexandre Sepriano, Tadej Avcin, George Bertsias, Georg Schett, Anne-Maree Keenan, Linda H Pololi, Laura C Coates, University of Oxford, Service de Rhumatologie [CHU Pitié Salpêtrière], 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), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), University of Brescia, Ruhr University Bochum (RUB), Department of Clinical Immunology and Rheumatology [Academic Medical Center, Amsterdam], University of Amsterdam [Amsterdam] (UvA), North Bristol NHS Trust [Bristol, UK], University of Bristol [Bristol], Amsterdam UMC - Amsterdam University Medical Center, University of Leeds, University of L'Aquila [Italy] (UNIVAQ), University of Glasgow, University of Belgrade [Belgrade], Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), University hospital of Zurich [Zurich], VU University Medical Center [Amsterdam], King‘s College London, University of Manchester [Manchester], University of Debrecen Egyetem [Debrecen], Leiden University Medical Center (LUMC), Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), University of Crete [Heraklion] (UOC), Universitätsklinikum Erlangen [Erlangen], NIHR - Leeds Musculoskeletal Biomedical Research Unit (LMBRU), National Institute for Health Research (NIHR), Brandeis University, Gestionnaire, Hal Sorbonne Université, Rehabilitation medicine, AMS - Ageing & Vitality, AMS - Musculoskeletal Health, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, APH - Societal Participation & Health, Rheumatology, AII - Inflammatory diseases, and AMS - Tissue Function & Regeneration
Subjects: Gender Equity, Male, [SDV]Life Sciences [q-bio], Immunology, health services research, Europe, [SDV] Life Sciences [q-bio], Cross-Sectional Studies, Rheumatology, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Immunology and Allergy, Humans, Female, epidemiology, ddc:610, Rheumatologists, qualitative research
Abstract: ObjectivesEvidence on the current status of gender equity in academic rheumatology in Europe and potential for its improvement is limited. The EULAR convened a task force to obtain empirical evidence on the potential unmet need for support of female rheumatologists, health professionals and non-clinical scientists in academic rheumatology.MethodsThis cross-sectional study comprised three web-based surveys conducted in 2020 among: (1) EULAR scientific member society leaders, (2) EULAR and Emerging EULAR Network (EMEUNET) members and (3) EULAR Council members. Statistics were descriptive with significance testing for male/female responses assessed by χ2 test and t-test.ResultsData from EULAR scientific member societies in 13 countries indicated that there were disproportionately fewer women in academic rheumatology than in clinical rheumatology, and they tended to be under-represented in senior academic roles. From 324 responses of EULAR and EMEUNET members (24 countries), we detected no gender differences in leadership aspirations, self-efficacy in career advancement and work–life integration as well as the share of time spent on research, but there were gender differences in working hours and the levels of perceived gender discrimination and sexual harassment. There were gender differences in the ranking of 7 of 26 factors impacting career advancement and of 8 of 24 potential interventions to aid career advancement.ConclusionsThere are gender differences in career advancement in academic rheumatology. The study informs a EULAR task force developing a framework of potential interventions to accelerate gender-equitable career advancement in academic rheumatology.
Published: 2022

9. EULAR points to consider when analysing and reporting comparative effectiveness research using observational data in rheumatology

Author: Courvoisier, Delphine Sophie, Lauper, Kim, Kedra, Joanna, de Wit, Maarten, Fautrel, Bruno, Frisell, Thomas, Hyrich, Kimme, Iannone, Florenzo, Machado, Pedro, Ørnbjerg, Lykke Midtbøll, Rotar, Ziga, Santos, Maria Jose, Stamm, Tanja, Stones, Simon, Strangfeld, Anja, Bergstra, Sytske Anne, Landewé, Robert, Finckh, Axel, Courvoisier, Delphine, Ørnbjerg, Lykke, Santos, Maria, Bergstra, Sytske, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, Université de Genève = University of Geneva (UNIGE), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), VU University Medical Center [Amsterdam], Service de Rhumatologie [CHU Pitié Salpêtrière], 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), Karolinska Institutet [Stockholm], University of Manchester [Manchester], Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Department of Genetics [Cambridge], University of Cambridge [UK] (CAM), Center for Healthy Aging [Copenhagen], Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH), University of Ljubljana, Hospital Garcia de Orta (EPE), Medizinische Universität Wien = Medical University of Vienna, University of Leeds, Deutsches Rheuma-ForschungsZentrum (DRFZ), Deutsches Rheuma-ForschungsZentrum, Leiden University Medical Center (LUMC), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, and Gestionnaire, HAL Sorbonne Université 5
Subjects: ddc:616, Comparative Effectiveness Research, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, endocrine system diseases, Epidemiology, Advisory Committees, Immunology, Health care, Reproducibility of Results, Patient reported outcome measures, health care, General Biochemistry, Genetics and Molecular Biology, Outcome assessment, Bias, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatology, patient reported outcome measures, Humans, Immunology and Allergy, epidemiology, outcome assessment
Abstract: BackgroundComparing treatment effectiveness over time in observational settings is hampered by several major threats, among them confounding and attrition bias.ObjectivesTo develop European Alliance of Associations for Rheumatology (EULAR) points to consider (PtC) when analysing and reporting comparative effectiveness research using observational data in rheumatology.MethodsThe PtC were developed using a three-step process according to the EULAR Standard Operating Procedures. Based on a systematic review of methods currently used in comparative effectiveness studies, the PtC were formulated through two in-person meetings of a multidisciplinary task force and a two-round online Delphi, using expert opinion and a simulation study. Finally, feedback from a larger audience was used to refine the PtC. Mean levels of agreement among the task force were calculated.ResultsThree overarching principles and 10 PtC were formulated, addressing, in particular, potential biases relating to attrition or confounding by indication. Building on Strengthening the Reporting of Observational Studies in Epidemiology guidelines, these PtC insist on the definition of the baseline for analysis and treatment effectiveness. They also focus on the reasons for stopping treatment as an important consideration when assessing effectiveness. Finally, the PtC recommend providing key information on missingness patterns.ConclusionTo improve the reliability of an increasing number of real-world comparative effectiveness studies in rheumatology, special attention is required to reduce potential biases. Adherence to clear recommendations for the analysis and reporting of observational comparative effectiveness studies will improve the trustworthiness of their results.
Published: 2022

10. Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis

Author: Sang Joon Lee, Roberto Caporali, Michael T. Nurmohamed, Yannick Allanore, Patrick Durez, Dae Hyun Yoo, Bernard Combe, Taek Sang Kwon, Florenzo Iannone, Rieke Alten, Jean Soo Choi, Gahee Park, University of Milan, 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), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Service de Rhumatologie [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université Catholique de Louvain = Catholic University of Louvain (UCL), Institut de Recherche Expérimentale et Clinique (IREC), Università degli studi di Bari Aldo Moro (UNIBA), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, VU University Medical Center [Amsterdam], Hanyang University, Rheumatology, ACS - Atherosclerosis & ischemic syndromes, AII - Inflammatory diseases, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, and UCL - (SLuc) Service de rhumatologie
Subjects: 0301 basic medicine, musculoskeletal diseases, rheumatoid arthritis, medicine.medical_specialty, Immunology, Administration, Cutaneous, Etanercept, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Adalimumab, Immunology and Allergy, Humans, skin and connective tissue diseases, Biosimilar Pharmaceuticals, 030203 arthritis & rheumatology, business.industry, Biosimilar, medicine.disease, Infliximab, 3. Good health, 030104 developmental biology, Systematic review, Treatment Outcome, Rheumatoid arthritis, Meta-analysis, Antirheumatic Agents, [SDV.IMM]Life Sciences [q-bio]/Immunology, Tumor necrosis factor alpha, Administration, Intravenous, biosimilar, business, infliximab, etanercept, CT-P13, medicine.drug
Abstract: International audience; Objectives: There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).Methods: Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621).Results: The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest. Comparison with pooled historical data suggested a numerical advan-tage for CT-P13 SC over intravenous infliximab for almost every prespecified efficacy outcome evaluated, including Disease Activity Score in 28 joints (C-reactive protein/erythrocyte sedimentation rate), Clinical/ Simplified Disease Activity Index scores, American College of Rheumatology responses, and multiple measures of disease remission and low disease activity; for the majority of outcomes, there was no overlap in 95% confidence intervals between groups. A numerical advantage for CT-P13 SC was also observed for safety outcomes (adverse events, infections, and discontinuations). Similar, but less marked, trends were observed for comparison with historical efficacy and safety data for adalimumab/etanercept.Conclusion: CT-P13 SC offers an improved or similar benefit-to-harm ratio compared with infliximab (intravenous) and adalimumab/etanercept, for the treatment of moderate-to-severe RA.
Published: 2021

11. EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis

Author: Heidi J. Siddle, Dirkjan van Schaardenburg, Kevin D. Deane, Francesca Ometto, Condruta Zabalan, Andrew P. Cope, Deshire Alpizar Rodriguez, Anca I. Catrina, Claire Daien, Annette H M van der Helm-van Mil, Juan D. Cañete, Daniel Aletaha, Karim Raza, Andreas Kerschbaumer, Kulveer Mankia, V. Michael Holers, Marios Koloumas, Hani S El Gabalawy, Axel Finckh, Paul Emery, University of Leeds, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Medizinische Universität Wien = Medical University of Vienna, Transverse group for research in primary care [Barcelona], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), King‘s College London, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), University of Colorado Anschutz [Aurora], University of Manitoba [Winnipeg], University of Geneva [Switzerland], University of Colorado [Denver], Universita degli Studi di Padova, Sandwell and West Birmingham NHS Trust (Sandwell General Hospital), University of Birmingham [Birmingham], Leiden University Medical Center (LUMC), Erasmus University Medical Center [Rotterdam] (Erasmus MC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, and Leeds Teaching Hospitals NHS Trust
Subjects: medicine.medical_specialty, rheumatoid, autoantibodies, Immunology, Arthritis, Asymptomatic, Severity of Illness Index, General Biochemistry, Genetics and Molecular Biology, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Risk Factors, Internal medicine, Epidemiology, medicine, Immunology and Allergy, Humans, Societies, Medical, 030304 developmental biology, 030203 arthritis & rheumatology, ddc:616, 0303 health sciences, Clinical Trials as Topic, business.industry, autoimmunity, Recommendation, medicine.disease, 3. Good health, Clinical trial, Europe, Observational Studies as Topic, Systematic review, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, arthritis, Rheumatoid arthritis, Antirheumatic Agents, Asymptomatic Diseases, Observational study, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, medicine.symptom, business, Rheumatism
Abstract: BackgroundDespite growing interest, there is no guidance or consensus on how to conduct clinical trials and observational studies in populations at risk of rheumatoid arthritis (RA).MethodsAn European League Against Rheumatism (EULAR) task force formulated four research questions to be addressed by systematic literature review (SLR). The SLR results informed consensus statements. One overarching principle, 10 points to consider (PTC) and a research agenda were proposed. Task force members rated their level of agreement (1–10) for each PTC.ResultsEpidemiological and demographic characteristics should be measured in all clinical trials and studies in at-risk individuals. Different at-risk populations, identified according to clinical presentation, were defined: asymptomatic, musculoskeletal symptoms without arthritis and early clinical arthritis. Study end-points should include the development of subclinical inflammation on imaging, clinical arthritis, RA and subsequent achievement of arthritis remission. Risk factors should be assessed at baseline and re-evaluated where appropriate; they include genetic markers and autoantibody profiling and additionally clinical symptoms and subclinical inflammation on imaging in those with symptoms and/or clinical arthritis. Trials should address the effect of the intervention on risk factors, as well as progression to clinical arthritis or RA. In patients with early clinical arthritis, pharmacological intervention has the potential to prevent RA development. Participants’ knowledge of their RA risk may inform their decision to participate; information should be provided using an individually tailored approach.ConclusionThese consensus statements provide data-driven guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in individuals at risk of RA.
Published: 2021

12. 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

13. What is axial spondyloarthritis? A latent class and transition analysis in the SPACE and DESIR cohorts

Author: Sepriano, A, Ramiro, S, Van Der Heijde, D., Hoonhout, P, Moltó, A., Saraux, A., Dougados, M., B. M. Landewe, R, Leiden University Medical Center (LUMC), ISEG-Lisbon School of Economics and Management (ISEG), University of Lisbon, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), 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), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC)
Subjects: [SDV.IMM]Life Sciences [q-bio]/Immunology, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2019

14. A proliferation‐inducing ligand–mediated anti‐inflammatory response of astrocytes in multiple sclerosis

Author: Mahdia Benkhoucha, Mashal Claude Ahmed, Dominique Baeten, Romain Marignier, Jose Boucraut, Olivier Casez, Michael Hahne, Jean Boutonnat, Corinne Sonrier, Benoit Manfroi, Laurie Baert, Patrice N. Marche, Nathalie Sturm, Marine Tessier, Patrice H. Lalive, Romain R. Vivès, Bertrand Huard, Cyril Rivat, Catherine Ghezzi, Hans Lassmann, Pascal Schneider, Natalia Popa, Gilda Raguenez, Alexis Broisat, Hugues Lortat-Jacob, Mitra Ahmadi, Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Department of Pathology and Immunology [Geneva, Switzerland] (Clinical Pathology Division), University of Geneva [Switzerland]-Geneva University Hospitals - HUG [Switzerland], Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département d'anatomie et cythologie pathologique, CHU Grenoble-Hôpital Michallon, Centre Hospitalier Universitaire [Grenoble] (CHU), Centre de recherche en neurosciences de Lyon (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Radiopharmaceutiques biocliniques (LRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Department of Clinical Immunology and Rheumatology [Academic Medical Center, Amsterdam], University of Amsterdam [Amsterdam] (UvA), Institut de biologie structurale (IBS - UMR 5075 ), Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut de Recherche Interdisciplinaire de Grenoble (IRIG), 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)-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)-Centre National de la Recherche Scientifique (CNRS), Department of Biochemistry [Lausanne], Université de Lausanne (UNIL), University of Vienna [Vienna], Department of Clinical Neurosciences [Geneva, Switzerland], Unit of Neuroimmunology and Neuromuscular Diseases [Geneva, Switzerland] (Division of Neurology), Geneva University Hospitals - HUG [Switzerland]-Geneva University Hospitals - HUG [Switzerland], This work was supported by Grenoble Alpes University (B.H.), the National Institute of Health and Medical Research (B.H.), the Association for Aid to Multiple Sclerosis Research (B.H.), the National Agency for Research (program center of excellence in neurodegeneration obtained within the Grenoble excellence in neurodegeneration network, B.H.), the Swiss National Science Foundation (310030_156961/310030_176256 to PS and 310030_153164/310030_176678 to PL), and the Swiss Multiple Sclerosis Society (P.L.)., Clinical Immunology and Rheumatology, AII - Inflammatory diseases, Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Université de Genève = University of Geneva (UNIGE)-Geneva University Hospitals - HUG [Switzerland], Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut des Neurosciences de Montpellier (INM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut de Recherche Interdisciplinaire de Grenoble (IRIG), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Université de Lausanne = University of Lausanne (UNIL), Grenoble Alpes University, the National Institute of Health and Medical Research, the Association for Aid to Multiple Sclerosis Research), the National Agency for Research (program center of excellence in neurodegeneration obtained within the Grenoble excellence in neurodegeneration network, the Swiss National Science Foundation (310030_156961/310030_176256 to PS and 310030_153164/310030_176678 )The Swiss Multiple Sclerosis Society, and MARCHE, Patrice
Subjects: Male, 0301 basic medicine, T-Lymphocytes, Mice, chemistry.chemical_compound, 0302 clinical medicine, B-Cell Activating Factor, Medicine, Mice, Knockout, Reverse Transcriptase Polymerase Chain Reaction, Chondroitin Sulfates, Middle Aged, Immunohistochemistry, Interleukin-10, 3. Good health, Interleukin 10, Neurology, Adult, Aged, Animals, Astrocytes/immunology, Astrocytes/metabolism, Astrocytes/pathology, B-Cell Activating Factor/metabolism, Cell Proliferation, Chondroitin Sulfate Proteoglycans/metabolism, Chondroitin Sulfates/metabolism, Cytokines/immunology, Disease Models, Animal, Encephalomyelitis, Autoimmune, Experimental/immunology, Encephalomyelitis, Autoimmune, Experimental/metabolism, Encephalomyelitis, Autoimmune, Experimental/pathology, Female, Humans, Interleukin-10/immunology, Macrophages/pathology, Multiple Sclerosis/immunology, Multiple Sclerosis/metabolism, Multiple Sclerosis/pathology, T-Lymphocytes/immunology, Tumor Necrosis Factor Ligand Superfamily Member 13/genetics, Tumor Necrosis Factor Ligand Superfamily Member 13/metabolism, Tumor Necrosis Factor Ligand Superfamily Member 13/pharmacology, Cytokines, [SDV.IMM]Life Sciences [q-bio]/Immunology, Tumor necrosis factor alpha, medicine.symptom, Encephalomyelitis, Autoimmune, Experimental, Multiple Sclerosis, [SDV.IMM] Life Sciences [q-bio]/Immunology, Tumor Necrosis Factor Ligand Superfamily Member 13, Inflammation, 03 medical and health sciences, [SDV.BBM] Life Sciences [q-bio]/Biochemistry, Molecular Biology, [SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology, B-cell activating factor, Autoimmune encephalitis, business.industry, Macrophages, Multiple sclerosis, medicine.disease, 030104 developmental biology, Chondroitin Sulfate Proteoglycans, chemistry, Chondroitin sulfate proteoglycan, Astrocytes, Immunology, Cytokine secretion, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: International audience; OBJECTIVE:The two related tumor necrosis factor members a proliferation-inducing ligand (APRIL) and B-cell activation factor (BAFF) are currently targeted in autoimmune diseases as B-cell regulators. In multiple sclerosis (MS), combined APRIL/BAFF blockade led to unexpected exacerbated inflammation in the central nervous system (CNS) of patients. Here, we investigate the role of the APRIL/BAFF axis in the CNS.METHODS:APRIL expression was analyzed in MS lesions by immunohistochemistry. The in vivo role of APRIL was assessed in the murine MS model, experimental autoimmune encephalitis (EAE). Functional in vitro studies were performed with human and mouse astrocytes.RESULTS:APRIL was expressed in lesions from EAE. In its absence, the disease was worst. Lesions from MS patients also showed APRIL expression upon infiltration of macrophages. Notably, all the APRIL secreted by these macrophages specifically targeted astrocytes. The upregulation of chondroitin sulfate proteoglycan, sometimes bearing chondroitin sulfate of type E sugar moieties, binding APRIL, in reactive astrocytes explained the latter selectivity. Astrocytes responded to APRIL by producing a sufficient amount of IL-10 to dampen antigen-specific T-cell proliferation and pathogenic cytokine secretion. Finally, an intraspinal delivery of recombinant APRIL before disease onset, shortly reduced EAE symptoms. Repeated intravenous injections of recombinant APRIL before and even at disease onset also had an effect.INTERPRETATION:Our data show that APRIL mediates an anti-inflammatory response from astrocytes in MS lesions. This protective activity is not shared with BAFF. ANN NEUROL 2019;85:406-420.© 2019 American Neurological Association.
Published: 2019

15. Brief Report: Interleukin‐17 Blockade With Secukinumab in Peripheral Spondyloarthritis Impacts Synovial Immunopathology Without Compromising Systemic Immune Responses

Author: Nataliya Yeremenko, Inka A. Fluri, Talia E. Latuhihin, Henriëtte M. de Jong, Leonieke J J van Mens, S. Menegatti, Marleen G H van de Sande, Lars Rogge, Sijia Chen, Iris C Blijdorp, Dominique Baeten, Arno W R van Kuijk, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Institut Pasteur [Paris], Department of Rheumatology & Clinical Immunology [Amsterdam, the Netherlands] (Amsterdam UMC), Amsterdam Infection & Immunity Institute [Amsterdam, the Netherlands]-University of Amsterdam [Amsterdam] (UvA), Institut Pasteur [Paris] (IP), University of Amsterdam [Amsterdam] (UvA)-Amsterdam Infection & Immunity Institute [Amsterdam, the Netherlands], Clinical Immunology and Rheumatology, Graduate School, AII - Inflammatory diseases, 01 Internal and external specialisms, General Internal Medicine, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism
Subjects: 0301 basic medicine, Male, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Synovial Membrane / drug effects, Severity of Illness Index, Spondylarthritis / immunology, 0302 clinical medicine, Immunopathology, Monoclonal, Immunology and Allergy, Synovial Membrane / immunology, Humanized, medicine.diagnostic_test, Spondylarthritis / drug therapy, Interleukin-17, Synovial Membrane, Antibodies, Monoclonal, Antirheumatic Agents / pharmacology, Middle Aged, 3. Good health, Cytokine, Treatment Outcome, Antirheumatic Agents, Erythrocyte sedimentation rate, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Interleukin 17, Interleukin-17 / immunology, Adult, Monoclonal / pharmacology, Immunology, Antibodies, Monoclonal, Humanized, Antibodies, 03 medical and health sciences, Psoriatic arthritis, Immune system, Rheumatology, Spondylarthritis, medicine, Biomarkers / blood, Humans, Spondylarthritis / blood, 030203 arthritis & rheumatology, Ankylosing spondylitis, business.industry, medicine.disease, 030104 developmental biology, Secukinumab, business, Biomarkers
Abstract: International audience; Objective: Secukinumab (anti-interleukin-17A [anti-IL-17A]) is an effective therapy for ankylosing spondylitis and psoriatic arthritis, the prototypical forms of spondyloarthritis (SpA). We undertook this study to determine whether secukinumab modulates the immunopathology of target lesions without blunting systemic immune responses, using peripheral SpA as a model.Methods: Twenty patients with active peripheral SpA were included in a 12-week open-label trial with secukinumab (300 mg once weekly from baseline to week 4 and then every 4 weeks thereafter). Outcomes included clinical response, cytokine production by peripheral blood cells using TruCulture technology, and histologic and real-time quantitative polymerase chain reaction analysis of synovial biopsy samples before and after treatment.Results: All patients completed the 12-week study without severe adverse events (AEs) or severe treatment-related AEs. The efficacy end point, the number of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at 12 weeks, was achieved by 13 of the 20 patients, of whom 8 achieved an ACR50 response and 5 achieved an ACR70 response, with rapid and significant improvements in all clinical disease activity measures. Clinical improvement in joint counts was associated with a histologic decrease in synovial sublining macrophages (P = 0.028) and neutrophils (P = 0.004), both of which are sensitive synovial biomarkers of inflammatory response in peripheral SpA, as well as with decreased synovial expression of IL-17A messenger RNA (mRNA) (P = 0.010) but not of tumor necrosis factor mRNA. Systemically, secukinumab treatment decreased the C-reactive protein level and the erythrocyte sedimentation rate (both P < 0.01), and also decreased matrix metalloproteinase 3 production in the TruCulture system (P < 0.05). However, with the exception of IL-17A itself, the capacity of peripheral blood cells to produce a broad panel of cytokines and chemokines upon stimulation with microbial antigens was not affected.Conclusion: This mechanism-of-action study in peripheral SpA indicates that clinical improvement with secukinumab treatment is paralleled by immunomodulation of inflamed target tissues without compromising systemic immune responses.
Published: 2018

16. How Are Enthesitis, Dactylitis and Nail Involvement Measured and Reported in Recent Clinical Trials of Psoriatic Arthritis? A Systematic Literature Review

Author: Laure Gossec, Sofia Ramiro, Désirée van der Heijde, Robert Landewé, Josef S Smolen, Leiden University Medical Center (LUMC), Medizinische Universität Wien = Medical University of Vienna, Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Zuyderland Hospital [Heerlen, The Netherlands], Service de Rhumatologie [CHU Pitié Salpêtrière], 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), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Gestionnaire, Hal Sorbonne Université, AII - Inflammatory diseases, Clinical Immunology and Rheumatology, and AII - Amsterdam institute for Infection and Immunity
Subjects: medicine.medical_specialty, [SDV]Life Sciences [q-bio], Immunology, MEDLINE, Hand Dermatoses, Enthesopathy, urologic and male genital diseases, General Biochemistry, Genetics and Molecular Biology, Dactylitis, Fingers, Nail Diseases, 03 medical and health sciences, Psoriatic arthritis, 0302 clinical medicine, Rheumatology, medicine, Humans, Immunology and Allergy, 030212 general & internal medicine, Foot Dermatoses, 030203 arthritis & rheumatology, Clinical Trials as Topic, business.industry, Arthritis, Psoriatic, Enthesitis, Toes, medicine.disease, Dermatology, Clinical trial, [SDV] Life Sciences [q-bio], Systematic review, Physical therapy, Outcomes research, medicine.symptom, business, Rheumatism
Abstract: While enthesitis, dactylitis and nail involvement are recognised as important outcomes of psoriatic arthritis (PsA) in the core set of domains in PsA,1 2 it is still unclear how these outcomes should best be measured.1 2 We systematically reviewed the instruments and the cut-offs used to report state or improvement, for enthesitis, dactylitis and nail involvement in recent randomised controlled trials (RCTs) in PsA. A systematic literature review of RCTs on any pharmacological intervention in patients with PsA was conducted to inform the European League Against Rheumatism (EULAR) recommendations for the management of PsA, by searching Medline, Embase and Cochrane datasets for the period 2010–2015.3 4 Only published papers and only results of the placebo-controlled phases were analysed. The presence and type of all outcome measures reflecting enthesitis, …
Published: 2018

17. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

Author: Dougados, Maxime, Maksymowych, Walter, Landewé, Robert, Moltó, Anna, Claudepierre, Pascal, de Hooge, Manouk, Lambert, Robert, Bonin, Randi, Bukowski, Jack, Jones, Heather, Logeart, Isabelle, Pedersen, Ron, Szumski, Annette, Vlahos, Bonnie, van Der Heijde, Désirée, Saraux, Alain, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), 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), CHU Cochin [AP-HP], Université Paris Descartes - Paris 5 (UPD5), University of Alberta, Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Laboratoire d'Investigation Clinique (LIC), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Department of Rheumatology (LEIDEN - Rhumato), Leiden University Medical Center (LUMC), Department of Geosciences, Pennsylvania State University (Penn State), Penn State System-Penn State System, Pfizer Ltd France, Pfizer, CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, 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), Calvez, Ghislaine, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pfizer, Collegeville, Pennsylvania, USA. (307152), and Pfizer France
Subjects: [SDV] Life Sciences [q-bio], [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience
Published: 2018

18. Systemic lupus erythematosus: state of the art on clinical practice guidelines

Author: Ricard Cervera, Sabrina Paolino, Angela Tincani, Ulf Mueller-Ladner, Hervé Devilliers, Gerd R Burmester, Zahir Amoura, Fabrizio Conti, Thierry Martin, Marcello Govoni, Laurent Arnaud, Carlo Alberto Scirè, Tadej Avcin, Matthias Schneider, Marta Mosca, Micaela Fredi, Ana Lladó, Carla Macieira, Maria G Tektonidou, Ilaria Galetti, Alain Cornet, Cristina Pamfil, Maurizio Cutolo, Vanessa Smith, Farah Tamirou, Stefano Bombardieri, Laura Massaro, Eric Hachulla, Frédéric Houssiau, Andrea Doria, Micol Frassi, Fonseca João Eurico, Ronald F van Vollenhoven, Rosaria Talarico, Tobias Alexander, Maria Francisca Moraes-Fontes, Sander W. Tas, Chiara Tani, Alessandra Bortoluzzi, N. Costedoat-Chalumeau, Université Catholique de Louvain = Catholic University of Louvain (UCL), Les Hôpitaux Universitaires de Strasbourg (HUS), Azienda Ospedaliero-Universitaria Pisana [Pisa, Italy], Università degli Studi di Ferrara (UniFE), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Clinic Barcelona Hospital Universitari, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Université de Bourgogne (UB), Azienda Ospedale Università di Padova = Hospital-University of Padua (AOUP), Spedali Civili Hospital [Brescia], Centro Hospitalar de Lisboa Central [Portugal], Centro Hospitalar Universitário Lisboa Norte [Lisbon, Portugal] (CHULN), University of Genoa (UNIGE), University of Amsterdam [Amsterdam] (UvA), Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), National and Kapodistrian University of Athens (NKUA), University of Pisa - Università di Pisa, Centre National de Référence des Maladies Auto-Immunes Systémiques Rares du Nord et Nord-Ouest de France (CeRAINO), Lille Inflammation Research International Center - U 995 (LIRIC), 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), CHU Lille, Kerckhoff clinic, Partenaires INRAE, Universitätsklinikum Düsseldorf, Universiteit Gent = Ghent University [Belgium] (UGENT), Hôpital Cochin [AP-HP], 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 (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Università degli Studi di Ferrara = University of Ferrara (UniFE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Università degli studi di Genova = University of Genoa (UniGe), Universiteit Gent = Ghent University (UGENT), 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), UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Tamirou, F, Arnaud, L, Talarico, R, Scire, C, Alexander, T, Amoura, Z, Avcin, T, Bortoluzzi, A, Cervera, R, Conti, F, Cornet, A, Devilliers, H, Doria, A, Frassi, M, Fredi, M, Govoni, M, Houssiau, F, Llado, A, Macieira, C, Martin, T, Massaro, L, Moraes-Fontes, M, Pamfil, C, Paolino, S, Tani, C, Tas, S, Tektonidou, M, Tincani, A, Van Vollenhoven, R, Bombardieri, S, Burmester, G, Eurico, F, Galetti, I, Hachulla, E, Mueller-Ladner, U, Schneider, M, Smith, V, Cutolo, M, Mosca, M, and Costedoat-Chalumeau, N
Subjects: medicine.medical_specialty, HCC DAUTOIM, Immunology, MEDLINE, Lupus nephritis, Lupus, Guidelines, AMERICAN-COLLEGE, DIAGNOSIS, Systemic Lupus Erythematosus, Unmet needs, NO, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), lupu, Rheumatology, immune system diseases, EUROPEAN LEAGUE, Immunology and Allergy, Internal medicine, medicine, Medicine and Health Sciences, MANAGEMENT, 030212 general & internal medicine, EVIDENCE-BASED RECOMMENDATIONS, Disease management (health), Intensive care medicine, RHEUMATIC-DISEASES, 030203 arthritis & rheumatology, RISK, business.industry, ASSOCIATION, medicine.disease, State of the Art, 3. Good health, Clinical Practice, EULAR RECOMMENDATIONS, PREGNANCY, [SDV.IMM]Life Sciences [q-bio]/Immunology, business
Abstract: Systemic lupus erythematosus (SLE) is the paradigm of systemic autoimmune diseases characterised by a wide spectrum of clinical manifestations with an unpredictable relapsing-remitting course. The aim of the present work was to identify current available clinical practice guidelines (CPGs) for SLE, to provide their review and to identify physicians' and patients' unmet needs. Twenty-three original guidelines published between 2004 and 2017 were identified. Many aspects of disease management are covered, including global disease management, lupus nephritis and neuropsychiatric involvement, management of pregnancies, vaccinations and comorbidities monitoring. Unmet needs relate with disease management of some clinical manifestations and adherence to treatment. Many patient's unmet needs have been identified starting with faster diagnosis, need for more therapeutic options, guidelines on lifestyle issues, attention to quality of life and adequate education. info:eu-repo/semantics/publishedVersion
Published: 2018

19. In patients with axial spondyloarthritis, inflammation on MRI of the spine is longitudinally related to disease activity only in men: 2 years of the axial spondyloarthritis DESIR cohort

Author: Maxime Dougados, Robert Landewé, Sofia Ramiro, Désirée van der Heijde, Victoria Navarro-Compán, C. Miceli-Richard, Pascal Richette, AII - Inflammatory diseases, Clinical Immunology and Rheumatology, Amsterdam institute for Infection and Immunity, Department of Rheumatology (LEIDEN - Rhumato), Leiden University Medical Center (LUMC), Department of Rheumatology and Clinical Epidemiology, Leiden University Medical Center (LUMC), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), Université Paris Descartes - Paris 5 (UPD5), 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)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Hôpital Lariboisière, 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), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, CHU Cochin [AP-HP], 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), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 (UPD7), and 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)
Subjects: Adult, Male, musculoskeletal diseases, 0301 basic medicine, medicine.medical_specialty, Radiography, [SDV]Life Sciences [q-bio], Immunology, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Sex Factors, 0302 clinical medicine, Rheumatology, Risk Factors, Internal medicine, Spondylarthritis, medicine, Humans, Immunology and Allergy, Longitudinal Studies, BASDAI, ComputingMilieux_MISCELLANEOUS, 030203 arthritis & rheumatology, Ankylosing spondylitis, biology, medicine.diagnostic_test, business.industry, C-reactive protein, Magnetic resonance imaging, medicine.disease, Magnetic Resonance Imaging, Spine, 030104 developmental biology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Erythrocyte sedimentation rate, Cohort, Disease Progression, biology.protein, Physical therapy, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract: The effects of inflammatory disease activity (DA) on radiographic progression in patients with axial spondyloarthritis (axSpA) are worse in men and smokers, but an explanation for this is lacking.1 Recently, we have found a relationship between inflammatory lesions in the sacroiliac joints (SIJs) detected by MRI and clinical DA measures in male patients, which was absent in female patients.2 Here, we investigate whether this gender-specific association between MRI-lesions and clinical DA extends to the spine. The objectives of this study were: (i) to explore the relationship between inflammatory lesions of the spine on MRI and DA in patients with axSpA; (ii) to investigate if such a relationship is gender specific and (iii) to explore the influence of other patient-related factors on the relationship between MRI of the spine and DA. Two-year follow-up data from 164 patients fulfilling Assessment of SpondyloArthritis international Society (ASAS) axSpA criteria in the DEvenir des Spondylarthopathies Indifferenciees Recentes (DESIR) cohort with at least two spine MRIs available during this period were analysed.3 ,4 The relationship between MRI-spine and DA (Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), patient’s global DA, night pain, C reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) was analysed by generalised estimating equations (GEEs) on absolute MRI-spine scores (Berlin …
Published: 2018

20. Response to: 'The GRAPPA-OMERACT initiative to standardise outcomes in Psoriatic Arthritis clinical trials and longitudinal observational studies' by Tillet et al

Author: Laure Gossec, Josef S. Smolen, Robert Landewé, Sofia Ramiro, Désirée van der Heijde, AII - Inflammatory diseases, Clinical Immunology and Rheumatology, Amsterdam institute for Infection and Immunity, Leiden University Medical Center (LUMC), Medizinische Universität Wien = Medical University of Vienna, Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service de Rhumatologie [CHU Pitié Salpêtrière], 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), Sorbonne Université (SU), Gestionnaire, Hal Sorbonne Université, Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: medicine.medical_specialty, Letter to the editor, [SDV]Life Sciences [q-bio], Immunology, Arthritis, General Biochemistry, Genetics and Molecular Biology, Dactylitis, 03 medical and health sciences, Psoriatic arthritis, 0302 clinical medicine, Rheumatology, medicine, Immunology and Allergy, Humans, Psoriasis, 030212 general & internal medicine, Longitudinal Studies, ComputingMilieux_MISCELLANEOUS, 030203 arthritis & rheumatology, psoriatic arthritis, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, treatment, business.industry, Arthritis, Psoriatic, Enthesitis, medicine.disease, 3. Good health, Clinical trial, [SDV] Life Sciences [q-bio], Systematic review, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Physical therapy, Observational study, medicine.symptom, business, disease activity
Abstract: We thank Tillet et al for their comments1 on our letter to the editor entitled ‘How are enthesitis, dactylitis and nail involvement measured and reported in recent clinical trials of psoriatic arthritis? A systematic literature review’.2 We appreciate that the authors are in agreement with our view regarding the clear need for the …
Published: 2018

21. Sacroiliac radiographic progression in recent onset axial spondyloarthritis: the 5-year data of the DESIR cohort

Author: Anna Molto, Manouk de Hooge, Sofia Ramiro, Alexandre Sepriano, Maxime Dougados, Rosaline van den Berg, Victoria Navarro Compan, C. Demattei, Miranda van Lunteren, Désirée van der Heijde, Robert Landewé, 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), Hôpital Cochin [AP-HP], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Leiden University Medical Center (LUMC), Department of Rheumatology and Clinical Epidemiology, Leiden University Medical Center (LUMC), Department of Rheumatology (LEIDEN - Rhumato), 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), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, 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), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, CHU Cochin [AP-HP]-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)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), 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), 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 de Montpellier (UM)-Université Montpellier 1 (UM1), AII - Inflammatory diseases, Clinical Immunology and Rheumatology, and AII - Amsterdam institute for Infection and Immunity
Subjects: 0301 basic medicine, Male, Time Factors, Radiography, [SDV]Life Sciences [q-bio], Severity of Illness Index, Cohort Studies, 0302 clinical medicine, Epidemiology, Immunology and Allergy, Axial spondyloarthritis, HLA-B27 Antigen, ComputingMilieux_MISCELLANEOUS, Sacroiliac joint, medicine.diagnostic_test, spondyloarthritis, Middle Aged, Magnetic Resonance Imaging, medicine.anatomical_structure, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Disease Progression, epidemiology, Female, France, musculoskeletal diseases, Adult, medicine.medical_specialty, Adolescent, Immunology, General Biochemistry, Genetics and Molecular Biology, outcomes research, 03 medical and health sciences, Young Adult, Rheumatology, Internal medicine, Spondylarthritis, medicine, Humans, Sacroiliitis, Recent onset, 030203 arthritis & rheumatology, business.industry, Magnetic resonance imaging, Sacroiliac Joint, Clinical and Epidemiological Research, medicine.disease, Surgery, 030104 developmental biology, Outcomes research, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: ObjectiveTo estimate sacroiliac joint radiographic (X-SIJ) progression in patients with axial spondyloarthritis (axSpA) and to evaluate the effects of inflammation on MRI (MRI-SIJ) on X-SIJ progression.MethodsX-SIJ and MRI-SIJ at baseline and after 2 and 5 years in patients with recent onset axSpA from the DESIR cohort were scored by three central readers. Progression was defined as (1) the shift from non-radiographic (nr) to radiographic (r) sacroiliitis (by modified New York (mNY) criteria) or alternative criteria, (2) a change of at least one grade or (3) a change of at least one grade but ignoring a change from grade 0 to 1. The effects of baseline inflammation on MRI-SIJ on 5-year X-SIJ damage (mNY) were tested by generalised estimating equations.ResultsIn 416 patients with pairs of baseline and 5-year X-SIJ present, net progression occurred in 5.1% (1), 13.0% (2) and 10.3% (3) respectively, regarding a shift from nr-axSpA to r-axSpA (1), a change of at least one grade (2) or a change of at least one grade but ignoring a change from grade 0 to 1 (3). Baseline MRI-SIJ predicted structural damage after 5 years in human leukocyte antigen-B27 (HLA-B27) positive (OR 5.39 (95% CI 3.25 to 8.94)) and in HLA-B27 negative (OR 2.16 (95% CI 1.04 to 4.51)) patients.ConclusionsFive-year progression of X-SIJ damage in patients with recent onset axSpA is limited but present beyond measurement error. Baseline MRI-SIJ inflammation drives 5-year radiographic changes.
Published: 2017

22. Disease activity is longitudinally related to sacroiliac inflammation on MRI in male patients with axial spondyloarthritis: 2-years of the DESIR cohort

Author: Victoria Navarro-Compán, Désirée van der Heijde, Robert Landewé, Corinne Miceli-Richard, Maxime Dougados, Sofia Ramiro, Pascal Richette, Department of Rheumatology (LEIDEN - Rhumato), Leiden University Medical Center (LUMC), Department of Rheumatology and Clinical Epidemiology, Leiden University Medical Center (LUMC), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Université Paris Descartes - Paris 5 (UPD5), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Université Sorbonne Paris Cité (USPC), CHU Le Kremlin-Bicêtre (Rheumatology Department), Department of Rheumatology, 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), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, 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), CHU Cochin [AP-HP], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Hôpital Lariboisière, and 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)
Subjects: Male, 0301 basic medicine, [SDV]Life Sciences [q-bio], Ankylosing Spondylitis, Severity of Illness Index, Cohort Studies, 0302 clinical medicine, Immunology and Allergy, Longitudinal Studies, BASDAI, ComputingMilieux_MISCELLANEOUS, Sacroiliac joint, biology, medicine.diagnostic_test, Magnetic Resonance Imaging, C-Reactive Protein, medicine.anatomical_structure, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Erythrocyte sedimentation rate, Cohort, Female, Cohort study, Adult, medicine.medical_specialty, Immunology, Blood Sedimentation, General Biochemistry, Genetics and Molecular Biology, Young Adult, 03 medical and health sciences, Sex Factors, Rheumatology, Internal medicine, Spondylarthritis, Spondyloarthritis, medicine, Humans, Sacroiliitis, 030203 arthritis & rheumatology, Inflammation, Ankylosing spondylitis, business.industry, C-reactive protein, Sacroiliac Joint, medicine.disease, 030104 developmental biology, Back Pain, biology.protein, Physical therapy, business, Biomarkers, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Objectives To investigate the longitudinal relationship between inflammatory lesions in sacroiliac joints on MRI (MRI-SI) and clinical disease activity measures (DA) in patients with axial spondyloarthritis (axSpA). Methods Two-year follow-up data from 167 patients (50% males, mean (SD) age 33 (9) years) fulfilling the Assessment of SpondyloArthritis international Society axSpA criteria in the DEvenir des Spondylarthopathies Indifferenciees Recentes cohort with MRI-SI at baseline, 1 year and 2 years were analysed. The relationship between MRI-SI (as dependent variable) and DA (Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), patient9s global DA, night pain, C reactive protein and erythrocyte sedimentation rate, as independent variables) was investigated using two types of generalised estimating equations (GEE) models: model of absolute scores and model of change scores. Results In the model of absolute scores, the relationship between DA and MRI-SI was different for males and females: in males, but not in females, a statistically significant relationship with MRI-SI was found for all DA except BASDAI. In the model of changes, only ASDAS (beta (95% CI): 2.79 (0.85 to 4.73) and pain at night (0.97 (0.04 to 1.90)) were significantly associated in males while again in females no significant relationship was found. ASDAS fitted the data best. Conclusions In male patients, but not in female patients, with axSpA, clinical DA, especially if measured by ASDAS, is longitudinally associated with MRI-SI inflammatory lesions.
Published: 2016

23. Preliminary definitions of ‘flare’ in axial spondyloarthritis, based on pain, BASDAI and ASDAS-CRP: an ASAS initiative

Author: Laure Gossec, Féline P B Kroon, Victoria Navarro-Compán, Maxime Dougados, Agnès Portier, Adrien Etcheto, Robert Landewé, Désirée van der Heijde, Institut Pierre Louis d'Epidémiologie et de Santé Publique ( iPLESP ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ), Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Université Paris Descartes - Faculté de Médecine ( UPD5 Médecine ), Université Paris Descartes - Paris 5 ( UPD5 ), Service de Rhumatologie [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Leiden University Medical Center (LUMC), La Paz University Hospital, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), Université Paris Descartes - Paris 5 (UPD5), 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), Universiteit Leiden, Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), HAL-UPMC, Gestionnaire, Service de Rhumatologie [CHU Pitié Salpêtrière], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: 0301 basic medicine, Male, Severity of Illness Index, 0302 clinical medicine, Reference Values, Surveys and Questionnaires, Immunology and Allergy, Medicine, flare, worsening, BASDAI, Axis, Cervical Vertebra, Pain Measurement, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Middle Aged, Systematic review, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Disease Progression, Female, Symptom Assessment, Adult, medicine.medical_specialty, Immunology, Pain, Context (language use), Sensitivity and Specificity, 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, Young Adult, outcome measures, Rheumatology, Spondylarthritis, Humans, Axial spondyloarthritis, ASAS, Aged, 030203 arthritis & rheumatology, Ankylosing spondylitis, Receiver operating characteristic, business.industry, Clinical study design, medicine.disease, 030104 developmental biology, ROC Curve, Physical therapy, Observational study, Outcomes research, business, disease activity
Abstract: IntroductionFlares may be used as outcomes in axial spondyloarthritis (axSpA) trials or observational studies. The objective was to develop a definition for ‘flare’ (or worsening) in axSpA, based on validated composite indices, to be used in the context of clinical trial design.Methods(1) Systematic literature review of definitions of ‘flare’ in published randomised controlled trials in axSpA. (2) Vignette exercise: 140 scenarios were constructed for a typical patient with axSpA seen at two consecutive visits. Each scenario included a change in one of the following outcomes: pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI plus C-reactive protein (CRP) or Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP. Each Assessment of Spondyloarthritis (ASAS) expert determined if every scenario from a random sample of 46 scenarios was considered a flare (yes/no). Receiver-operating characteristic (ROC) analyses were applied to derive optimal cut-off values. (3) ASAS consensus was reached.Results(1) The literature review yielded 38 studies using some definition of ‘flare’, with 27 different definitions indicating important heterogeneity. The most frequent definitions were based on BASDAI changes or pain changes. (2) 121 ASAS experts completed 4999 flare assessments. The areas under the ROC curves were high (range: 0.88–0.89). Preliminary cut-offs for pain (N=3), BASDAI (N=5) and ASDAS-CRP (N=4) were chosen, with a range of sensitivity 0.60–0.99 and range of specificity 0.40–0.94 against the expert's opinions.ConclusionsThis data-driven ASAS consensus process has led to 12 preliminary draft definitions of ‘flare’ in axSpA, based on widely used indices. These preliminary definitions will need validation in real patient data.
Published: 2016

24. Updating the OMERACT Filter: Implications for Patient-reported Outcomes

Author: M. Voshaar, Anne Lyddiatt, Wilma Smeets, Amye L. Leong, James W. May, T.K. Kvien, Pamela Montie, Maarten Boers, John R. Kirwan, Dorcas E. Beaton, Peter Tugwell, Susan J. Bartlett, Lyn March, Vibeke Strand, Ernest Choy, Ailsa Bosworth, Laure Gossec, Sarah Hewlett, Pam Richards, Peter Brooks, Francis Guillemin, Maarten de Wit, Robert Landewé, Enkeleida Nikaï, Institute for Work and Health (IWH), University of Toronto-St. Michael's Hospital-Institute of Medical Sciences, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center [Amsterdam], National Rheumatoid Arthritis Society (NRAS), Institut Jacques Monod (IJM (UMR_7592)), Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), EULAR standing committee of People with Arthritis/Rheumatism in Europe (PARE), Ecole de Santé Publique [Nancy], Faculté de Médecine [Nancy], Université de Lorraine (UL)-Université de Lorraine (UL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Université Sorbonne Paris Cité (USPC), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Institute of Bone & Joint Research, Royal North Shore Hospital (RNSH)-The University of Sydney, Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, University of Ottawa [Ottawa], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Stanford University School of Medicine [Stanford], Stanford University [Stanford], University of Ottawa [Ottawa] (uOttawa), CHU Cochin [AP-HP], Institute for Work and Health ( IWH ), University Medical Center, National Rheumatoid Arthritis Society ( NRAS ), Institut Jacques Monod ( IJM ), Université Paris Diderot - Paris 7 ( UPD7 ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Lorraine ( UL ) -Université de Lorraine ( UL ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université de Lorraine ( UL ) -Université Paris Descartes - Paris 5 ( UPD5 ), Université Sorbonne Paris Cité ( USPC ), Royal North Shore Hospital ( RNSH ) -The University of Sydney [Sydney], Amsterdam institute for Infection and Immunity, Clinical Immunology and Rheumatology, Epidemiology and Data Science, Rheumatology, and CCA - Innovative therapy
Subjects: medicine.medical_specialty, MESH: Self Report, International studies, Immunology, Alternative medicine, MESH : Rheumatic Diseases, MESH : Self Report, MESH : Randomized Controlled Trials as Topic, Outcome (game theory), Filter (software), Session (web analytics), MESH: Patient Participation, law.invention, MESH: Rheumatic Diseases, Randomized controlled trial, Rheumatology, law, Rheumatic Diseases, MESH: Rheumatology, MESH : Outcome and Process Assessment (Health Care), Immunology and Allergy, Medicine, Humans, Good practice, MESH : Rheumatology, OUTCOME AND PROCESS ASSESSMENT, Randomized Controlled Trials as Topic, RANDOMIZED CONTROLLED TRIALS, Medical education, MESH: Humans, business.industry, MESH : Reproducibility of Results, MESH : Humans, Reproducibility of Results, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH : Patient Participation, MESH: Reproducibility of Results, Outcome and Process Assessment, Health Care, MESH: Randomized Controlled Trials as Topic, PATIENT-REPORTED OUTCOMES, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Self Report, Patient Participation, business, Working group, MESH: Outcome and Process Assessment (Health Care)
Abstract: Objective.At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the “Truth” statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied.Methods.Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved.Results.Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons.Conclusion.Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.
Published: 2014

25. Emerging role of IL-17 and Th17 cells in systemic lupus erythematosus

Author: Dominique Baeten, Régis Josien, Jerome Martin, Le Bihan, Sylvie, Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Institut de transplantation urologie-néphrologie (ITUN), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Laboratoire d'Immunologie [CHU Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), Department of Clinical Immunology and Rheumatology [Academic Medical Center, Amsterdam], and University of Amsterdam [Amsterdam] (UvA)
Subjects: medicine.medical_specialty, Ankylosing spondylitis, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Interleukin-17, Immunology, SLE, Disease, medicine.disease, Models, Biological, Unmet needs, IL-17, Psoriasis, medicine, Humans, Lupus Erythematosus, Systemic, Th17 Cells, Immunology and Allergy, Interleukin 17, Th17, Intensive care medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Despite the success of targeted therapies in managing immune-mediated inflamma-tory diseases (IMIDs) such as RA, IBDs, MS and psoriasis, unmet needs for such approach in SLE are widely recognized. In the past 2 years, exciting insights supporting previous lines of evidence on the role of the IL-23/IL-17 axis in SLE have emerged. This is of particular importance as IL-17 blockers have now moved successfully into the clinical space, as illustrated in psoriasis and ankylosing spondylitis. However, recent fundamental studies also highlighted unexpected aspects of IL-17/Th17 biology whose comprehension may prevent disappointing results of IL-17 targeting such as those obtained in Crohn's disease. Therefore, establishing a current picture of the IL-17 pre-clinical situation in SLE is timely in order to plan future proof-of-concept studies in human.
Published: 2014

26. Circulating miRNA-125b Is a Potential Biomarker Predicting Response to Rituximab in Rheumatoid Arthritis

Author: Sylvie Fabre, Dominique Baeten, Isabelle Touitou, Meryem Ammari, Florence Apparailly, Guillaume Cartron, Yves-Marie Pers, Christian Jorgensen, Isabelle Duroux-Richard, 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), Service d'immuno-rhumatologie[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Dynamique des interactions membranaires normales et pathologiques (DIMNP), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Université Montpellier 1 (UM1), Philips, Alexandre, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université Montpellier 1 (UM1)-Université Montpellier 2 - Sciences et Techniques (UM2)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Amsterdam institute for Infection and Immunity, and Clinical Immunology and Rheumatology
Subjects: Male, Article Subject, Inflammatory arthritis, [SDV]Life Sciences [q-bio], Immunology, Arthritis, Inflammation, Arthritis, Rheumatoid, Antibodies, Monoclonal, Murine-Derived, Predictive Value of Tests, lcsh:Pathology, medicine, Humans, ComputingMilieux_MISCELLANEOUS, Aged, business.industry, Cell Biology, Middle Aged, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], MicroRNAs, Treatment Outcome, Gene Expression Regulation, Antirheumatic Agents, Rheumatoid arthritis, Predictive value of tests, Chronic Disease, Monoclonal, Clinical Study, Biomarker (medicine), Female, Rituximab, medicine.symptom, business, Biomarkers, lcsh:RB1-214, medicine.drug
Abstract: Although biologic therapies have changed the course of rheumatoid arthritis (RA), today’s major challenge remains to identify biomarkers to target treatments to selected patient groups. Circulating micro(mi)RNAs represent a novel class of molecular biomarkers whose expression is altered in RA. Our study aimed at quantifying miR-125b in blood and serum samples from RA patients, comparing healthy controls and patients with other forms of rheumatic diseases and arthritis, and evaluating its predictive value as biomarker for response to rituximab. Detectable levels of miR-125b were measured in total blood and serum samples and were significantly elevated in RA patients compared to osteoarthritic and healthy donors. The increase was however also found in patients with other forms of chronic inflammatory arthritis. Importantly, high serum levels of miR-125b at disease flare were associated with good clinical response to treatment with rituximab three months later (P=0.002). This predictive value was not limited to RA as it was also found in patients with B lymphomas. Our results identify circulating miR-125b as a novel miRNA over expressed in RA and suggest that serum level of miR-125b is potential predictive biomarker of response to rituximab treatment.
Published: 2014

27. Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of 'truth': content, face, and construct validity

Author: Daniel E. Furst, Dorcas E. Beaton, Tore K Kvien, Laure Gossec, George Wells, Désirée van der Heijde, Peter Tugwell, Jasvinder A. Singh, Maarten Boers, Turid Heiberg, Philip G. Conaghan, Lee S. Simon, Philip J. Mease, Robert Landewé, Annelies Boonen, Vibeke Strand, John R. Kirwan, Cátia Duarte, M.A. D'Agostino, Sarah Hewlett, Francis Guillemin, Mikkel Østergaard, Maxime Dougados, Clifton O. Bingham, Ernest Choy, Amsterdam institute for Infection and Immunity, Clinical Immunology and Rheumatology, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center [Amsterdam], Service de Rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Ambroise Paré, Institute for Work and Health (IWH), University of Toronto-St. Michael's Hospital-Institute of Medical Sciences, Maastricht University Medical Center (MUMC), Maastricht University [Maastricht], Section of Musculoskeletal Diseasee, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, 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), Ecole de Santé Publique [Nancy], Faculté de Médecine [Nancy], Université de Lorraine (UL)-Université de Lorraine (UL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), CHU Cochin [AP-HP], Østfold University College, Leiden University Medical Center (LUMC), Université Sorbonne Paris Cité (USPC), Dpt of Clinical Immunology & Rheumatology [Amsterdam], Amsterdam and Atrium Medical Center, Center for Rheumatology and Spine Diseases, Copenhagen (Center for Rheumatology and Spine Diseases), Stanford University School of Medicine [Stanford], Stanford University [Stanford], University of Ottawa [Ottawa] (uOttawa), Epidemiology and Data Science, Rheumatology, CCA - Innovative therapy, University Medical Center, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Ambroise Paré, Institute for Work and Health ( IWH ), Maastricht University Medical Center ( MUMC ), 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 ), Université de Lorraine ( UL ) -Université de Lorraine ( UL ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université de Lorraine ( UL ) -Université Paris Descartes - Paris 5 ( UPD5 ), Université Sorbonne Paris Cité ( USPC ), Center for Rheumatology and Spine Diseases, Copenhagen ( Center for Rheumatology and Spine Diseases ), University of Ottawa [Ottawa], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], Maastricht University Medical Centre (MUMC), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, Interne Geneeskunde, RS: CAPHRI School for Public Health and Primary Care, and RS: CAPHRI - Effectiveness of Diagnosis and Intervention in patients with Rheumatic Diseases
Subjects: musculoskeletal diseases, Settore MED/16 - REUMATOLOGIA, Immunology, MESH : Rheumatic Diseases, Truth Disclosure, Outcome (game theory), Article, MESH: Rheumatic Diseases, CONSTRUCT VALIDITY, CONTENT VALIDITY, Rheumatology, Rheumatic Diseases, MESH: Rheumatology, MESH : Outcome and Process Assessment (Health Care), Content validity, Humans, Immunology and Allergy, Medicine, MESH : Rheumatology, OUTCOME AND PROCESS ASSESSMENT, Face validity, RANDOMIZED CONTROLLED TRIALS, Information retrieval, MESH: Humans, business.industry, Avaliação de Resultados e Processos, MESH : Reproducibility of Results, MESH : Humans, Reproducibility of Results, Construct validity, Reumatologia, OMERACT, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, humanities, MESH : Truth Disclosure, Health Care, MESH: Reproducibility of Results, Outcome and Process Assessment, Health Care, Doenças Reumáticas, Filter (video), Face (geometry), MESH: Truth Disclosure, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Working group, business, FACE VALIDITY, MESH: Outcome and Process Assessment (Health Care)
Abstract: Objective.The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The “Truth” section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity.Methods.Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved.Results.The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address.Conclusion.These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.
Published: 2014

28. Predictive immunomonitoring — The COST ENTIRE initiative

Author: Dusan Popadic, Carmen Scheibenbogen, Sarah Thunberg, Frank O. Nestle, Ola Winqvist, Emina Savic, Ignacio Anegon, Thomas Giese, Barbara Seliger, Federica Villanova, Françoise Mascart, Ann-Charlotte Wikström, Per Marits, M. Turina, Eva Martínez-Cáceres, Dominique Baeten, Ricardo Pujol-Borrell, Hermann Eibel, Institute of Microbiology and Immunology [Belgrade, Serbia] (School of Medicine), University of Belgrade [Belgrade], Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Institut de transplantation urologie-néphrologie (ITUN), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Department of Rheumatology & Clinical Immunology [Amsterdam, the Netherlands] (Amsterdam UMC), University of Amsterdam [Amsterdam] (UvA)-Amsterdam Infection & Immunity Institute [Amsterdam, the Netherlands], Centre for Chronic Immunodeficiency [Freiburg, Germany], University Medical Centre [Freiburg, Germany], Institute for Immunology [Heidelberg, Germany], Heidelberg University Hospital [Heidelberg], Unit of Translational Immunology [Stockholm, Sweden] (Department of Medicine), Karolinska Institutet [Stockholm], Department of Cellular Biology, Physiology and Immunology [Barcelona, Spain], Universitat Autònoma de Barcelona (UAB), Laboratory of Vaccinology and Mucosal Immunity [Brussels, Belgium], Université libre de Bruxelles (ULB), St. John's Institute of Dermatology, King‘s College London, Institute of Medical Immunology [Berlin, Germany], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Institute of Medical Immunology [Halle/Saale, Germany], Martin-Luther-University Halle-Wittenberg, Clinical immunology and transfusion medicine [Stockholm, Sweden], Karolinska University Hospital [Stockholm], Le Bihan, Sylvie, Autonomous University of Barcelona, Amsterdam institute for Infection and Immunity, and Clinical Immunology and Rheumatology
Subjects: medicine.medical_specialty, International Cooperation, Immunology, Health Promotion, Translational Research, Biomedical, 03 medical and health sciences, 0302 clinical medicine, Text mining, medicine, Humans, Organizational Objectives, Immunology and Allergy, Intensive care medicine, ComputingMilieux_MISCELLANEOUS, 030304 developmental biology, Inflammation, 0303 health sciences, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, medicine.disease, Europe, Immune System Diseases, 030220 oncology & carcinogenesis, Physical therapy, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience
Published: 2013

29. The systemic lupus erythematosus IRF5 risk haplotype is associated with systemic sclerosis

Author: F David Carmona, Jose-Ezequiel Martin, Lorenzo Beretta, Carmen P Simeón, Patricia E Carreira, José Luis Callejas, Mónica Fernández-Castro, Luis Sáez-Comet, Emma Beltrán, María Teresa Camps, María Victoria Egurbide, Spanish Scleroderma Group, Paolo Airó, Raffaella Scorza, Claudio Lunardi, Nicolas Hunzelmann, Gabriela Riemekasten, Torsten Witte, Alexander Kreuter, Jörg H W Distler, Rajan Madhok, Paul Shiels, Jacob M van Laar, Carmen Fonseca, Christopher Denton, Ariane Herrick, Jane Worthington, Annemie J Schuerwegh, Madelon C Vonk, Alexandre E Voskuyl, Timothy R D J Radstake, Javier Martín, Rheumatology, CCA - Disease profiling, The Spanish Scleroderma Group, [Carmona,FD, Martín JE] Instituto de Parasitología y Biomedicina López-Neyra, CSIC, Granada, Spain. [ Beretta,L, Scorza,R] Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, University of Milan, Italy. [ Carmen,P S] Department of Internal Medicine, Hospital Vall d’Hebron, Barcelona, Spain. [Carreira,P E] Department of Rheumatology, Hospital 12 de Octubre, Madrid, Spain. [Callejas,J.L. ] Department of Internal Medicine, Hospital Clínico San Cecilio, Granada, Spain. [Fernández-Castro,M.] Department of Rheumatology, Hospital Puerta de Hierro Majadahonda, Madrid, Spain. [Sáez-Comet,L] Department of Internal Medicine, Hospital Universitario Miguel Servet, Zaragoza, Spain. [Beltran,E.] Department of Rheumatology, Hospital General Universitario de Valencia, Spain. [Camps,MT.] Department of Internal Medicine, Hospital Carlos Haya, Málaga, Spain. [Egurbide,M.V.] Department of Internal Medicine, Hospital de Cruces, Barakaldo, Spain. [Airo,P.] Servizio di Reumatologia ed Immunologia Clinica Spedali Civili, Brescia, Italy. [Lunardi,C] Department of Medicine, Universita` degli Studi di Verona, Verona, Italy. [Hunzelmann, N] Department of Dermatology, University of Cologne, Cologne, Germany. [Riemekasten,G] Department of Rheumatology and Clinical Immunology, Charite´ University Hospital, Berlin, Germany. [Witte,T] Hannover Medical School, Hannover, Germany. [Kreuter,A] Ruhr University of Bochum, Germany. [Distler,JHW] Department of Internal Medicine 3, Institute for Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany. [Madhok,R, Shiels,P] Centre for Rheumatic Diseases, Glasgow Royal Infirmary, University of Glasgow, United Kingdom. [Van Laar,JM] Institute of Cellular Medicine, Newcastle University, Newcastle, United Kingdom. [Fonseca,C, Denton,C] Centre for Rheumatology, Royal Free and University College Medical School, London, United Kingdom. [Herrick,A, Worthington, J] Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom. [Schuerwegh,AJ] Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. [Vonk,MC, Radstake,T.R.D] Department of Rheumatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. [Voskuyl,AE] Department of Rheumatology, VU University Medical Center, Amsterdam, The Netherlands. [Radstake,T.R.D] Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, The Netherland., and 17552, Arthritis Research UK, United Kingdom
Subjects: Male, Linkage disequilibrium, Phenomena and Processes::Genetic Phenomena::Phenotype [Medical Subject Headings], Polimorfismo de nucleótido simple, SLE, lcsh:Medicine, Autoimmunity, Genome-wide association study, Linkage Disequilibrium, Scleroderma, Phenomena and Processes::Genetic Phenomena::Genotype::Haplotypes [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Gene Frequency, Named Groups::Persons::Population Groups::Continental Population Groups::European Continental Ancestry Group [Medical Subject Headings], Risk Factors, IRF5, Genetics of the Immune System, Lupus Erythematosus, Systemic, Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Scleroderma, Systemic [Medical Subject Headings], skin and connective tissue diseases, lcsh:Science, Multidisciplinary, Diseases::Immune System Diseases::Autoimmune Diseases::Lupus Erythematosus, Systemic [Medical Subject Headings], Predisposición genética a la enfermedad, Phenomena and Processes::Genetic Phenomena::Genetic Linkage::Linkage Disequilibrium [Medical Subject Headings], Phenomena and Processes::Genetic Phenomena::Genotype::Genetic Predisposition to Disease [Medical Subject Headings], Phenotype, Interferon Regulatory Factors, SYSTEMIC SCLEROSIS, Medicine, Evaluation of complex medical interventions Auto-immunity, transplantation and immunotherapy [NCEBP 2], Female, TYPE I INTERFERON, Haplotipos, Research Article, Factores de riesgo, Immunology, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Peptides::Intracellular Signaling Peptides and Proteins::Adaptor Proteins, Signal Transducing::Interferon Regulatory Factors [Medical Subject Headings], Check Tags::Male [Medical Subject Headings], Health Care::Environment and Public Health::Public Health::Epidemiologic Factors::Causality::Risk Factors [Medical Subject Headings], Single-nucleotide polymorphism, Human leukocyte antigen, Biology, Polymorphism, Single Nucleotide, White People, Autoimmune Diseases, Rheumatology, Lupus eritematoso sistémico, Genetics, Humans, Genetic Predisposition to Disease, Grupo de ascendencia continental europea, Allele, Allele frequency, Alleles, Genetic Association Studies, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genes::Alleles [Medical Subject Headings], Scleroderma, Systemic, Haplotype, lcsh:R, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genetic Loci [Medical Subject Headings], Human Genetics, Phenomena and Processes::Genetic Phenomena::Genetic Variation::Polymorphism, Genetic [Medical Subject Headings], Factores reguladores del interferón, Haplotypes, Desequilibrio de ligamiento, Check Tags::Female [Medical Subject Headings], Genetic Loci, Genetics of Disease, Genetic Polymorphism, Clinical Immunology, lcsh:Q, Phenomena and Processes::Genetic Phenomena::Gene Frequency [Medical Subject Headings], Population Genetics
Abstract: Systemic sclerosis (SSc) is a fibrotic autoimmune disease in which the genetic component plays an important role. One of the strongest SSc association signals outside the human leukocyte antigen (HLA) region corresponds to interferon (IFN) regulatory factor 5 (IRF5), a major regulator of the type I IFN pathway. In this study we aimed to evaluate whether three different haplotypic blocks within this locus, which have been shown to alter the protein function influencing systemic lupus erythematosus (SLE) susceptibility, are involved in SSc susceptibility and clinical phenotypes. For that purpose, we genotyped one representative single-nucleotide polymorphism (SNP) of each block (rs10488631, rs2004640, and rs4728142) in a total of 3,361 SSc patients and 4,012 unaffected controls of Caucasian origin from Spain, Germany, The Netherlands, Italy and United Kingdom. A meta-analysis of the allele frequencies was performed to analyse the overall effect of these IRF5 genetic variants on SSc. Allelic combination and dependency tests were also carried out. The three SNPs showed strong associations with the global disease (rs4728142: P = 1.34×10-8, OR = 1.22, CI 95% = 1.14-1.30; rs2004640: P = 4.60×10-7, OR = 0.84, CI 95% = 0.78-0.90; rs10488631: P = 7.53×10-20, OR = 1.63, CI 95% = 1.47-1.81). However, the association of rs2004640 with SSc was not independent of rs4728142 (conditioned P = 0.598). The haplotype containing the risk alleles (rs4728142*A-rs2004640*T-rs10488631*C: P = 9.04×10-22, OR = 1.75, CI 95% = 1.56-1.97) better explained the observed association (likelihood P-value = 1.48×10-4), suggesting an additive effect of the three haplotypic blocks. No statistical significance was observed in the comparisons amongst SSc patients with and without the main clinical characteristics. Our data clearly indicate that the SLE risk haplotype also influences SSc predisposition, and that this association is not sub-phenotype-specific. © 2013 Carmona et al.
Published: 2013

30. Analysis of the association between CD40 and CD40 ligand polymorphisms and systemic sclerosis

Author: Teruel, María, Simeón Aznar, Carmen Pilar, Broen, Jasper C., Vonk, Madelon C., Carreira, Patricia, Camps García, María Teresa, García-Portales, Rosa, Delgado-Frías, Esmeralda, Gallego, Maria, Espinosa Garriga, Gerard, Spanish Scleroderma Study Group (SSSG), Beretta, Lorenzo, Airó, Paolo, Lunardi, Claudio, Riemekasten, Gabriela, Witte, Torsten, Krieg, Thomas, Kreuter, Alexander, Distler, Jörg H.V., Hunzelmann, Nicolas, Koeleman, Bobby P. C., Voskuyl, Alexandre E., Schuerwegh, Annemie J., González-Gay, Miguel A., Radstake, Timothy R.D.J., Martín, Javier, Narváez García, Francisco Javier, Rheumatology, CCA - Immuno-pathogenesis, Universitat de Barcelona, The Spanish Scleroderma Group, [Teruel,M, Martin,J] Instituto de Parasitología y Biomedicina López-Neyra, IPBLN-CSICGranada, SpainArmilla (Granada), Spain. [Simeon,CP] Department of Internal Medicine, Hospital Valle de Hebron, Barcelona, Spain. [Broen,J, Vonk,MC] Department of Rheumatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. [Carreira,P] Department of Rheumatology, Hospital 12 de Octubre, Madrid, Spain. [Camps,MT] Department of Internal Medicine, Hospital Carlos Haya, Málaga, Spain. [García-Portales,R] Department of Rheumatology, Hospital Virgen de la Victoria, Málaga, Spain. [Delgado-Frías,E] Department of Rheumatology, Hospital Universitario de Canarias, La Cuesta, San Cristóbal de La Laguna, Tenerife, Canarias, Spain. [Gallego,M] Department of Internal Medicine, Hospital Central de Asturias, Oviedo, Spain. [Espinosa,G] Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Spain. [Beretta,L] Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico. University of Milan, Milan, Italy. [Airó,P] Rheumatology Unit and Chair, Spedali Civili, Università degli Studi, Brescia, Italy. [Lunardi,C] Department of Medicine, Policlinico GB Rossi, Università degli studi di Verona, Verona, Italy. [Riemekasten,G] Department of Rheumatology and Clinical Immunology, Charité University Hospital and German Rheumatism Research Centre, a Leibniz Institute, Berlin, Germany. [Witte,T] Clinic for Immunology and Rheumatology Medical School, Hannover, Germany. [Krieg,T, and Hunzelmann,N] Department of Dermatology, University of Cologne, Germany. [Kreuter,A] Department of Dermatology, Allergology, and Venereology, Ruhr University of Bochum, Bochum, Germany. [Distler,JHW] Department of Internal Medicine 3, Institute for Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany. [Koeleman,BP] Section Complex Genetics, Department of Medical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands. [Voskuy,AE] Department of Rheumatology, VU University Medical Center, Amsterdam, The Netherlands. [Schuerwegh,AJ] Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. [González-Gay,MA] Department of Rheumatology, Hospital Universitario Marques de Valdecilla, IFIMAV, Santander, Spain. [Radstake,TRDJ] Department of Rheumatology and Clinical Immunology, University Utrecht Medical Center Utrecht, The Netherlands.
Subjects: systemic sclerosis, Autoimmune diseases, Genome-wide association study, CD40, CD40L, GWAS, Serology, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Pulmonary fibrosis, Genotype, Immunology and Allergy, Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Scleroderma, Systemic [Medical Subject Headings], skin and connective tissue diseases, Giant cell arteritis, 0303 health sciences, Chemicals and Drugs::Biological Factors::Antigens::Antigens, Surface::Antigens, Differentiation::Antigens, CD::Antigens, CD40 [Medical Subject Headings], Malalties autoimmunitàries, integumentary system, Predisposición genética a la enfermedad, Fibrosi pulmonar, Phenomena and Processes::Genetic Phenomena::Genotype::Genetic Predisposition to Disease [Medical Subject Headings], Phenotype, Infection and autoimmunity Auto-immunity, transplantation and immunotherapy [NCMLS 1], Humanos, 3. Good health, 030220 oncology & carcinogenesis, Evaluation of complex medical interventions Auto-immunity, transplantation and immunotherapy [NCEBP 2], Phenomena and Processes::Genetic Phenomena::Genotype [Medical Subject Headings], Research Article, medicine.medical_specialty, Esclerodermia sistémica, Immunology, CD40 Ligand, Single-nucleotide polymorphism, Polymorphism, Single Nucleotide, 03 medical and health sciences, Rheumatology, Internal medicine, medicine, Humans, antígenos CD40, Genetic Predisposition to Disease, CD40 Antigens, Gene, Arteritis de cèl·lules gegants, 030304 developmental biology, Phenomena and Processes::Genetic Phenomena::Genetic Variation::Polymorphism, Genetic::Polymorphism, Single Nucleotide [Medical Subject Headings], Scleroderma, Systemic, business.industry, Chemicals and Drugs::Biological Factors::Antigens::Antigens, Surface::Antigens, Differentiation::Antigens, CD::CD40 Ligand [Medical Subject Headings], medicine.disease, Ligando CD40, Scleroderma (Disease), Polimorfismo de Nucleótido Simple, Esclerodèrmia, business, Genotipo
Abstract: Introduction The aim of the present study was to investigate the possible role of CD40 and CD40 ligand (CD40LG) genes in the susceptibility and phenotype expression of systemic sclerosis (SSc). Methods In total, 2,670 SSc patients and 3,245 healthy individuals from four European populations (Spain, Germany, The Netherlands, and Italy) were included in the study. Five single-nucleotide polymorphisms (SNPs) of CD40 (rs1883832, rs4810485, rs1535045) and CD40LG (rs3092952, rs3092920) were genotyped by using a predesigned TaqMan allele-discrimination assay technology. Meta-analysis was assessed to determine whether an association exists between the genetic variants and SSc or its main clinical subtypes. Results No evidence of association between CD40 and CD40LG genes variants and susceptibility to SSc was observed. Similarly, no significant statistical differences were observed when SSc patients were stratified by the clinical subtypes, the serologic features, and pulmonary fibrosis. Conclusions Our results do not suggest an important role of CD40 and CD40LG gene polymorphisms in the susceptibility to or clinical expression of SSc., This work was supported by the following grants. JM was funded by SAF2009-11110 from the Spanish Ministry of Science, by CTS-4977 and PI-0590-2010 from Junta de Andalucía, and by RETICS Program, RD08/0075 (RIER) from Instituto de Salud Carlos III (ISCIII), within the VI PN de I+D+i 2008-2011 (FEDER). T.R.D.J.R. was funded by the VIDI laureate from the Dutch Association of Research (NWO) and Dutch Arthritis Foundation (National Reumafonds). JM and TRDJR were sponsored by the Orphan Disease Program grant from the European League Against Rheumatism (EULAR). TW was awarded grants by DFG WI 1031/6.1 and DFG KFO 250 TP03. MT was supported by Spanish Ministry of Science through the program Juan de la Cierva (JCI-2010-08227).
Published: 2012

31. Systemic phenotype related to primary Sjogren's syndrome in 279 patients carrying isolated anti-La/SSB antibodies

Author: Nihan Acar-Denizli, Horváth, I. -F, Mandl, T., Priori, R., Vissink, A., Hernandez-Molina, G., Armagan, B., Praprotnik, S., Sebastian, A., Bartoloni, E., Rischmueller, M., Pasoto, S. G., Nordmark, G., Nakamura, H., Fernandes Moça Trevisani, V., Retamozo, S., Carsons, S. E., Maure-Noia, B., Sánchez-Berná, I., López-Dupla, M., Fonseca-Aizpuru, E., Melchor Díaz, S., Vázquez, M., Díaz Cuiza, P. E., Miguel Campo, B., Ng, W. -F, Rasmussen, A., Dong, X., Li, X., Baldini, C., Seror, R., Gottenberg, J. -E, Kruize, A. A., Sandhya, P., Gandolfo, S., Kwok, S. -K, Kvarnstrom, M., Solans, R., Sene, D., Suzuki, Y., Isenberg, D. A., Valim, V., Hofauer, B., Giacomelli, R., Devauchelle-Pensec, V., Atzeni, F., Gheita, T. A., Morel, J., Izzo, R., Kalyoncu, U., Szántó, A., Olsson, P., Bootsma, H., Ramos-Casals, M., Kostov, B., Brito-Zerón, P., Statistics and Operations Research Department-Universitat Politècnica de Catalunya, Department of Immunology [Debrecen, Hungary], University of Debrecen [Hungary], Department of Rheumatology (Dep Rheumato - Malmo - SUEDE), Skåne University Hospital, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Departement of Oral and Maxillofacial Surgery, Groningen, Univesity of Medical Center Groningen, Immunology and Rheumatology Department, Mexico City, Department of Internal Medicine, Ankara (Hacettepe University), Department of Rheumatology (Dep Rheumato - Ljubljana - SLOVENIE), University Medical Centre Slovenia, Department of Rheumatology and Internal Medicine, Wroclaw, Department of Medicine [Perugia, Italy] (Rheumatology, Unit), Università degli Studi di Perugia (UNIPG), University of South Australia [Adelaide], Rheumatology Division, Hospital das Clinicas, Sao Paulo (HCFMUSP), Department of Medical Sciences Uppsala University Hospital Uppsala, Department of Immunology and Rheumatology, Nagasaki, Japan, Federal University of Sao Paulo, Rheumatology Unit, Cordoba (Institute University of Biomedical Sciences University of Cordoba (IUCBC), NYU Long Island School of Medecine, Mineola, NY, USA, Complexo Hospitalario Universitario de Vigo, Partenaires INRAE, Hospital Rey Juan Carlos de Mostoles, Madrid, Spain, University Hospital of Tarragona 'Joan XXIII', Hospital de Cabueñes, Hospital Universitario 12 de Octubre [Madrid], Hospital de Clinicas, San Lorenzo, Paraguay, Seguro Social Universotario y consultorio privado de Reumatologia, Sucre, Bolivia, NIHR Biomedical Research Centre, Oklahoma Medical Research Foundation (OMRF), Peking Union Medical College Hospital [Beijing] (PUMCH), Departement of Rheumatology and Immunology, Hefei (Anhui Provincial Hospital), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Rheumatology [CHU Strasbourg], CHU Strasbourg, Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), Department of Clinical Immunology and Rheumatology, Vellore (Christian Medical College & Hospital), Université d'Udine, The Catholic University of Korea [Seoul, Korea], University of Stockolm, Vall d'Hebron University Hospital [Barcelona], Service de médecine interne, Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris, F-75010, Paris, Kanazawa University Hospital, Kanazawa, Ishikawa, Japan, University College of London [London] (UCL), Federal University of Espirito Santo, Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), University of L'Aquila [Italy] (UNIVAQ), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), IRCCS Istituto Ortopedico Galeazzi, Kasr Al-Ainy Medical School, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Ankara University School of Medicine [Turkey], Debrecen University, Faculty of Medicine, Skane University Hospital [Malmo], Lund University [Lund], Department of Rheumatology and Clinical Immunology Groningen (Dep Rheum - GRONINGEN), University Medical Center Groningen [Groningen] (UMCG), Laboratory of Autoimmune Diseases Josep Font Barcelona, CELLEX-IDIBAPS Department of Autoimmune Diseases, Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), and Universitat de Barcelona (UB)
Subjects: MESH: Humans, MESH: Registries, education, MESH: Phenotype, eye diseases, Cohort Studies, stomatognathic diseases, Phenotype, Sjogren's Syndrome, MESH: Sjogren's Syndrome, stomatognathic system, Humans, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Registries, MESH: Cohort Studies, MESH: Female, health care economics and organizations
Abstract: To evaluate the systemic phenotype associated with the presence of isolated anti-La/SSB antibodies in a large international registry of patients with primary Sjögren's syndrome (pSS) fulfilling the 2002 classification criteria.The Big Data Sjögren Project Consortium is an international, multicentre registry created in 2014. Baseline clinical information from leading centres on clinical research in SS of the 5 continents was collected. Combination patterns of anti-Ro/SSA-La/SSB antibodies at the time of diagnosis defined the following four immunological phenotypes: double positive (combined Ro/SSA and La/SSB,) isolated anti-Ro/SSA, isolated anti-La/SSB, and immunonegative.The cohort included 12,084 patients (11,293 females, mean 52.4 years) with recorded ESSDAI scores available. Among them, 279 (2.3%) had isolated anti-La/SSB antibodies. The mean total ESSDAI score at diagnosis of patients with pSS carrying isolated anti-La/SSB was 6.0, and 80.4% of patients had systemic activity (global ESSDAI score ≥1) at diagnosis. The domains with the highest frequency of active patients were the biological (42.8%), glandular (36.8%) and articular (31.2%) domains. Patients with isolated anti-La/SSB showed a higher frequency of active patients in all ESSDAI domains but two (articular and peripheral nerve) in comparison with immune-negative patients, and even a higher absolute frequency in six clinical ESSDAI domains in comparison with patients with isolated anti-Ro/SSA. In addition, patients with isolated anti-La/SSB showed a higher frequency of active patients in two ESSDAI domains (pulmonary and glandular) with respect to the most active immunological subset (double-positive antibodies). Meanwhile, systemic activity detected in patients with isolated anti-La/SSB was overwhelmingly low. Even in ESSDAI domains where patients with isolated anti-La/SSB had the highest frequencies of systemic activity (lymphadenopathy and muscular), the percentage of patients with moderate or high activity was lower in comparison with the combined Ro/SSA and La/SSB group.Patients carrying isolated La/SSB antibodies represent a very small subset of patients with a systemic SS phenotype characterised by a significant frequency of active patients in most clinical ESSDAI domains but with a relative low frequency of the highest severe organ-specific involvements. Primary SS still remains the best clinical diagnosis for this subset of patients.

32. Why are local epidural glucocorticoid injections associated with fractures? Drug, disease, or both?

Author: Lems W and Boers M
Published: 2024
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33. Circulating Adipokines and Response to Treatment in Patients With Early Rheumatoid Arthritis.

Author: Vasileiadis GK, Zhang Y, Fatima T, van Vollenhoven R, Lampa J, Gudbjornsson B, Haavardsholm EA, Nordström D, Grondal G, Hørslev-Petersen K, Lend K, Heiberg MS, Hetland ML, Nurmohamed M, Uhlig T, Sokka-Isler T, Rudin A, and Maglio C
Abstract: Objective: The objective of this study was to determine if baseline adiponectin, leptin, and resistin levels are associated with response to antirheumatic treatment in early rheumatoid arthritis (RA)., Methods: This study included 341 participants of the Nordic Rheumatic Diseases Strategy Trials and Registries trial with untreated early RA, randomized at baseline into four treatment arms: methotrexate combined with (1) prednisolone, (2) certolizumab, (3) abatacept, or (4) tocilizumab. Follow-up was up to 48 weeks. Adipokines were measured in plasma at baseline with enzyme-linked immunosorbent assay. The primary outcome for this report was the difference in remission (Clinical Disease Activity Index [CDAI] ≤2.8) over 48 weeks stratified by median adipokine levels., Results: At baseline, levels of adiponectin and leptin were not associated with markers of RA activity, whereas participants with higher resistin levels had higher C-reactive protein (CRP) levels, swollen joint count, and Disease Activity Score in 28 joints based on CRP compared to participants with lower resistin. Overall, participants with baseline adipokine levels above the median and those with adipokine levels below the median had similar mean CDAI and changes in CDAI throughout follow-up for up to 48 weeks. Adjusted Cox proportional hazards models did not show any effect of baseline adiponectin, leptin, and resistin levels on the likelihood of achieving CDAI remission (adiponectin: hazard ratio [HR] 1.08, 95% confidence interval [CI] 0.80-1.45, P = 0.62; leptin: HR 0.89, 95% CI 0.64-1.26, P = 0.52; resistin: HR 0.86, 95% CI 0.65-1.13, P = 0.26)., Conclusion: Baseline adiponectin, leptin, and resistin levels are not associated with the likelihood of achieving CDAI remission over 48 weeks of treatment in a large cohort of people with untreated early RA., (© 2024 The Author(s). ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
Published: 2024
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34. The longitudinal association of hand osteoarthritis with paid and unpaid work restrictions and related societal costs: the Hand Osteoarthritis in Secondary Care cohort.

Author: Terpstra SES, van de Stadt LA, Boonen A, Groenwold RHH, Rosendaal FR, and Kloppenburg M
Abstract: Objectives: To investigate the course of restrictions in paid and unpaid work and corresponding societal costs in patients with hand osteoarthritis (OA)., Methods: Patients with data of at least baseline and one follow-up moment (year one up to year eight) of the Dutch Hand OSTeoArthritis in Secondary care cohort (HOSTAS) were included. The Health and Labour Questionnaire (HLQ) was used to assess over the last two weeks hand OA-related restrictions for paid and unpaid work. Societal costs of productivity loss were estimated with Dutch government data on 2021., Results: 351 patients were included (mean age 60 years, 84% women). At baseline, 166/351 (47%) had paid work, decreasing to 54/164 (33%) at year eight. Loss of productive time over the two-week period was reported by 32/166 (19%) patients with paid work at baseline, 17/104 (16%) at year four, among whom 12/104 (11%) patients at both moments. Any restrictions over this two-week period were experienced by 89/166 patients (54%) at baseline and 41/104 (39%) at year four for those with paid work. Regarding unpaid work, 157/351 (45%) reported replacement of tasks by others at baseline and 72/164 (44%) at year eight. 205/351 (59%) reported restrictions at baseline, and 99/164 (60%) at year eight. Mean total societal costs for loss of paid and unpaid work were, per patient, €89/two weeks (95% confidence interval (CI) 52;127) at baseline, and €47/two weeks (26;69) at year eight., Conclusions: The proportion of patients with paid work decreases during follow-up, but restrictions at paid and unpaid work seem mostly stable., (Copyright © 2024. Published by Elsevier Ltd.)
Published: 2024
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35. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials.

Author: Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, and Nikpour M
Subjects: Humans, Female, Male, Adult, Middle Aged, Treatment Outcome, Randomized Controlled Trials as Topic, Severity of Illness Index, Lupus Erythematosus, Systemic drug therapy, Antibodies, Monoclonal, Humanized therapeutic use, Remission Induction, Immunosuppressive Agents therapeutic use
Abstract: Background: Disease remission or low disease activity are key treatment targets for patients with systemic lupus erythematosus (SLE). Pivotal trials of belimumab were conducted before the introduction of these targets. In this study, we aimed to pool data across trials to assess attainment of remission and low disease activity in a large, racially and culturally diverse patient population with SLE., Methods: In this integrated post-hoc analysis, we pooled data from five phase 3 trials of belimumab (BLISS-76 [NCT00410384], BLISS-52 [NCT00424476], BLISS-NEA [NCT01345253], BLISS-SC [NCT01484496], and EMBRACE [NCT01632241]), in patients with active, autoantibody-positive SLE. Patients were randomly assigned to receive belimumab (10 mg/kg per month intravenously or 200 mg per week subcutaneously) or placebo, plus standard therapy. The proportion of patients with Definitions of Remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) were analysed every 4 weeks from week 4 to week 52 for belimumab versus placebo, using modified Poisson regression adjusted for trial variance, in all patients and in subgroups per baseline SLE Disease Activity Index-2000 score (<10 or ≥10); anti-double stranded DNA positivity (yes or no); low complement 3 (C3) or C4 levels (yes or no); anti-dsDNA positivity or low C3 or C4 levels (yes and no); prednisone-equivalent dose (≤7·5 mg per day or >7·5 mg per day); antimalarial use (yes or no); and by race (Black African ancestry or African American, Asian, Indigenous American, or White)., Findings: Data for 3086 patients (1869 in the belimumab group and 1217 in the placebo group) were analysed. 2913 (94%) of 3086 patients were women and 173 (6%) were men, and the median age was 36 years (IQR 28-45). The proportion of patients with DORIS remission was significantly higher in the belimumab group than the placebo group at weeks 28, 48, and 52 (week 52: 148 [8%] of 1869 participants vs 68 [6%] of 1217 participants; risk ratio 1·51 [95% CI 1·15-1·99]; p=0·0055). The proportion of patients who attained LLDAS was higher in the belimumab group than the placebo group at weeks 8, 24, 32-52 (week 52: 322 [17%] of 1869 participants vs 125 [10%] of 1217 participants; 1·74 [1·44-2·12]; p<0·0001). A higher proportion of patients had DORIS remission at week 52 in the belimumab group than the placebo group among all baseline subgroups denoting high disease activity, with the exception of those on a prednisone-equivalent dose higher than 7·5 mg per day in whom there was no difference for DORIS remission with belimumab versus placebo. The proportion of patients with LLDAS was significantly higher among patients in the belimuab group than those who received placebo from week 44 in all baseline subgroups denoting high disease activity or earlier in some subgroups, and the differences were maintained at week 52., Interpretation: In adults with active SLE, belimumab plus standard therapy yielded greater benefit than placebo plus standard therapy in attaining DORIS remission (for which low rates were attained in both groups) and LLDAS, with differences observed as early as week 28 for DORIS remission and week 8 for LLDAS., Funding: Swedish Rheumatism Association, King Gustaf V's 80-year Foundation, Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and the Karolinska Institutet., Competing Interests: Declaration of interests IP reports grants and speaker honoraria from Amgen, AstraZeneca, Aurinia, BMS, Eli Lilly, Gilead, GSK, Janssen, Novartis, Otsuka, and Roche. MZ reports speaker honoraria from Eli Lilly, AstraZeneca, and GSK. AA has received consulting fees from AbbVie, Amgen, AstraZeneca, Aurinia, BMS, Celgene, Eli Lilly, Idorsia, Janssen, Genentech, GSK, Mallinckrodt, Pfizer, and UCB. RvV reports grants from Pfizer and Roche; consulting fees from AbbVie, AstraZeneca, Biogen, Biotest, BMS, Galapagos, Gilead, Janssen, Pfizer, Sanofi, Servier, UCB, and Vielabio; and speaker honoraria from AbbVie, Galapagos, GSK, Janssen, Pfizer, UCB, and Roche. MN reports grants from Janssen Pharmaceuticals; and consulting fees and speaker honoraria from AstraZeneca, Boehringer Ingelheim, GSK, and Janssen Pharmaceuticals. RAL, CH, MK, HAQ, and DC are employees of GSK and hold stocks and shares in the company. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
Published: 2024
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36. Does high hepatic bioavailability enhance the effect of oral compared to subcutaneous glucocorticoids?

Author: van Geel EH, Boers M, Hartman L, and Smulders YM
Subjects: Humans, Administration, Oral, Male, Middle Aged, Female, Pilot Projects, Adult, Injections, Subcutaneous, Blood Sedimentation, Arthritis, Psoriatic drug therapy, Treatment Outcome, Aged, Time Factors, Glucocorticoids administration & dosage, Glucocorticoids pharmacokinetics, Prednisolone administration & dosage, Prednisolone pharmacokinetics, Biological Availability, Cross-Over Studies, Liver metabolism, Liver drug effects, Arthritis, Rheumatoid drug therapy
Abstract: Objectives: Glucocorticoids (GC) are important in the treatment of autoinflammatory disorders. Oral prednisolone ≤5 mg/day can be effective, but such doses are at or even below physiological daily endogenous GC production. We hypothesised that their immunosuppressive effect might be explained by high hepatic bioavailability of oral GC, exposing the liver to supraphysiological GC via the portal circulation. We tested this by comparing the effect of oral versus subcutaneous low-dose prednisolone, on erythrocyte sedimentation rate (ESR)., Methods: Patients with rheumatoid arthritis or psoriatic arthritis, elevated ESR (≥30 mm/h) and no current or recent GC therapy were eligible. In a pilot study (n=5), 5 mg/day oral prednisolone decreased ESR significantly, suggesting a sample size of 10 patients for a randomised, non-blinded crossover trial. Patients received 5 mg/day prednisolone for 2 periods of 4 days: one treatment period orally and one subcutaneously with a 10-day washout period between treatments. ESR was measured before (day 1 and 15) and after (day 5 and 19) each treatment course., Results: 10 patients were included. ESR decreased after both oral and subcutaneous prednisolone, by -5.6 (20.9) and -5.8 (3.0) mm/h, respectively (p=0.98). The treatment order had no effect on the outcome., Conclusions: . Short-term oral low-dose GC therapy is not more effective than parental GC in decreasing ESR, arguing against therapeutic high hepatic bioavailability effects. More likely, systemic concentration peaks following administration explain why oral physiological steroid doses are clinically effective.
Published: 2024
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37. Performance of clinical, laboratory and imaging features for diagnosing spondyloarthritis-a systematic literature review and meta-analysis.

Author: Bento da Silva A, Lourenço MH, Ramiro S, Falzon L, Cunha-Branco J, van der Heijde D, Landewé R, and Sepriano A
Subjects: Humans, Sensitivity and Specificity, HLA-B27 Antigen blood, Sacroiliitis diagnostic imaging, C-Reactive Protein analysis, Radiography, Magnetic Resonance Imaging, Spondylarthritis diagnostic imaging, Spondylarthritis diagnosis
Abstract: Objective: The Berlin algorithm was developed to help diagnose axial SpA (axSpA), but new studies suggest some features typical of SpA are less specific than previously assumed. Furthermore, evidence is lacking for other SpA subtypes (e.g. peripheral SpA). We aimed to review the evidence on the performance of SpA features for diagnosing each SpA subtype., Methods: We conducted a systematic literature review of studies reporting the diagnostic performance of one or more SpA features in patients with suspected SpA. The external reference was the rheumatologist's diagnosis of SpA. Meta-analysis was performed, separately for each SpA subtype, to estimate pooled sensitivity, specificity and positive and negative likelihood ratios (LR+ and LR-, respectively). Meta-regression assessed the effect of covariates (e.g. feature's prevalence) on each feature's performance., Results: Of 13 844 articles screened, 46 were included. Sacroiliitis on MRI, damage on pelvic radiographs and elevated CRP had the best balance between LR+ and LR- (LR+ 3.9-17.0, LR- 0.5-0.7) for diagnosing axSpA. HLA-B27 had an LR+ lower than anticipated (LR+ 3.1). Inflammatory back pain (IBP) had a low LR+ (LR+ ≈1), but substantially decreased the likelihood of axSpA when absent (LR- 0.3). Conversely, peripheral features and extramusculoskeletal manifestations showed a high LR+ (LR+ 1.6-5.0), but were as common in axSpA as non-axSpA (LR- ≈1). The specificity of most features was reduced in settings when these were highly prevalent. Limited data precluded a detailed analysis on diagnosing other SpA subtypes., Conclusion: Imaging features and CRP have good diagnostic value for axSpA. However, the specificity of other features, especially HLA-B27 and IBP, is lower than previously known., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Published: 2024
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38. Baseline and 2-year differences in spinal symptoms and spinal and hip mobility in early axial spondyloarthritis and non-axial spondyloarthritis chronic back pain patients.

Author: Bento da Silva A, Ramiro S, van Lunteren M, Marques ML, van de Sande M, Fongen C, Exarchou S, Ramonda R, van der Heijde D, and van Gaalen FA
Subjects: Humans, Female, Male, Adult, Middle Aged, Range of Motion, Articular, Spine physiopathology, Spine pathology, Severity of Illness Index, Back Pain etiology, Back Pain diagnosis, Back Pain physiopathology, Chronic Pain etiology, Chronic Pain diagnosis, Chronic Pain physiopathology, Axial Spondyloarthritis diagnosis, Axial Spondyloarthritis etiology
Abstract: Objective: To compare spinal symptoms and spinal/hip mobility at baseline and 2 years in early axial spondyloarthritis (axSpA) and non-axSpA chronic back pain (BP) patients., Methods: Baseline and 2 years data of the SPondyloarthritis Caught Early cohort were analysed. Outcomes assessed: overall BP, BP at night, morning stiffness (MS) intensity, MS duration, occiput-to-wall distance (OWD), cervical rotation, chest expansion, lateral spinal flexion (LSF), modified Schober test (mSchober), intermalleolar distance (IMD) and Bath Ankylosing Spondylitis Metrology Index (BASMI). Linear or zero-inflated negative binomial regression was used to compare 2 years outcomes between groups (adjusting for baseline value, sex, age and use of non-steroidal anti-inflammatory drugs)., Results: There were 294 axSpA and 123 non-axSpA patients (mean symptom duration: 13 months). At baseline, non-axSpA patients had worse symptoms and mobility, except OWD (eg, mean(SD): BP at night 3.6 (2.9) axSpA vs 4.6 (2.7) non-axSpA; OWD 0.5 (1.2) vs 0.1 (0.7)). After 2 years, all symptoms and cervical rotation significantly improved in both groups, but LSF and mSchober only in axSpA. In multivariable analyses, axSpA was associated with larger improvements in BP at night (β (95% CI): -0.85 (-1.47; -0.23)), mSchober (0.26 (0.03; 0.50)), IMD (4.86 (1.93; 7.80)) and BASMI (-0.24 (-0.41; -0.08)), and with lower likelihood of a normal OWD (OR (95% CI): 0.09 (0.01; 0.83))., Conclusion: Over 2 years, all spinal symptoms and some mobility measures improved in both groups, but impairments remained prevalent (particularly in non-axSpA). Nevertheless, axSpA was associated with larger improvements in BP at night, mSchober, IMD and BASMI, but with more OWD impairment., Competing Interests: Competing interests: SR has received research grants and/or consultancy fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB and Sanofi. MvdS has acknowledged speakers fees from Janssen, Novartis, UCB and Beneke, consulting fees from Janssen, Novartis, Abbvie and UCB, and research support from Janssen, Novartis and UCB. SE has received consulting fees from Amgen, Janssen, Novartis, AbbVie and UCB. RR has received consulting and/or speaking fees from Advisory Boards from Abbvie, Novartis, Janssen, Lilly, MSD, Pfizer and UCB. DvdH has acknowledge consulting fees from AbbVie, Argenx, BMS, Galapagos, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda and UCB; associate editor Annals Rheumatic Diseases, editorial board member Journal of Rheumatology and RMD Open, Advisor Assessment Axial Spondyloarthritis international Society and director of Imaging Rheumatology bv. FAvG has received grants/research supports from Stichting ASAS, Novartis and UCB, and received honoraria or consultation fees from Novartis, BMS, AbbVie, MSD, Janssen, Lily and UCB. The remaining authors have declared no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2024
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39. Correspondence on 'Risk of cardiovascular disease with high-dose versus low-dose use of non-steroidal anti-inflammatory drugs in ankylosing spondylitis' by Kim et al .

Author: Landewé RBM and Boers M
Abstract: Competing Interests: Competing interests: None declared.
Published: 2024
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40. Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study.

Author: Aranow C, Allaart CF, Amoura Z, Bruce IN, Cagnoli PC, Chatham WW, Clark KL, Furie R, Groark J, Urowitz MB, van Vollenhoven R, Daniels M, Fox NL, Gregan YI, Henderson RB, van Maurik A, Ocran-Appiah JC, Oldham M, Roth DA, Shanahan D, Tak PP, and Teng YO
Subjects: Humans, Female, Adult, Double-Blind Method, Male, Middle Aged, Treatment Outcome, Injections, Subcutaneous, Drug Administration Schedule, Remission Induction, Antibodies, Antinuclear blood, Severity of Illness Index, Antirheumatic Agents administration & dosage, Antirheumatic Agents therapeutic use, Lupus Erythematosus, Systemic drug therapy, Lupus Erythematosus, Systemic immunology, Rituximab administration & dosage, Rituximab therapeutic use, Rituximab adverse effects, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized therapeutic use, Drug Therapy, Combination, Immunosuppressive Agents administration & dosage, Immunosuppressive Agents therapeutic use
Abstract: Objectives: Disease activity control in patients with systemic lupus erythematosus (SLE) with corticosteroid and immunosuppressant withdrawal is a treatment goal. We evaluated whether this could be attained with sequential subcutaneous belimumab (BEL) and one cycle of rituximab (RTX)., Methods: In this phase 3, double-blind BLISS-BELIEVE trial (GSK Study 205646), patients with active SLE initiating subcutaneous BEL 200 mg/week for 52 weeks were randomised to intravenous placebo (BEL/PBO) or intravenous RTX 1000 mg (BEL/RTX) at weeks 4 and 6 while stopping concomitant immunosuppressants/tapering corticosteroids; standard therapy for 104 weeks (BEL/ST; reference arm) was included., Primary Endpoint: proportion of patients achieving disease control (SLE Disease Activity Index-2000 (SLEDAI-2K) ≤2; without immunosuppressants; prednisone equivalent ≤5 mg/day) at week 52 with BEL/RTX versus BEL/PBO. Major (alpha-controlled) secondary endpoints: proportion of patients with clinical remission (week 64; clinical SLEDAI-2K=0, without immunosuppressants/corticosteroids); proportion of patients with disease control (week 104). Other assessments: disease control duration, anti-dsDNA antibody, C3/C4 and B cells/B-cell subsets., Results: The modified intention-to-treat population included 263 patients. Overall, 16.7% (12/72) of BEL/PBO and 19.4% (28/144) of BEL/RTX patients achieved disease control (OR (95% CI) 1.27 (0.60 to 2.71); p=0.5342) at week 52. For major secondary endpoints, differences between BEL/RTX and BEL/PBO were not statistically significant. Anti-dsDNA antibodies and most assessed B cells/B-cell subsets were lower with BEL/RTX versus BEL/PBO. Mean disease control duration through 52 weeks was significantly greater with BEL/RTX versus BEL/PBO., Conclusions: BEL/RTX showed no superiority over BEL/PBO for most endpoints analysed; however, it led to significant improvements in disease activity markers compared with BEL/PBO. Further investigation of combination treatment is warranted., Trial Registration Number: NCT03312907., Competing Interests: Competing interests: CA has received research support from GSK; consulting fees from GSK, AstraZeneca, BMS, Kezar Life Sciences Inc., Merck Sharp & Dohme and Alumis Inc. CFA has received research support from Janssen, AbbVie, and Eli Lilly. ZA has received research support from GSK, Roche, AstraZeneca, and Amgen; and consulting fees from GSK, AstraZeneca, Amgen, Kezar Life Sciences Inc, and Novartis. INB has received research support from Genzyme, Sanofi, and GSK; consulting fees from AstraZeneca, Eli Lilly, Aurinia Pharmaceuticals, GSK, and ILTOO; and has served as an advisory board member for AstraZeneca and Merck Serono. INB is a National Institute for Health Research (NIHR) Senior Investigator Emeritus and is funded by the NIHR Manchester Biomedical Research Centre (NIHR203308). PCC has received consulting and speaker fees from GSK, Aurinia Pharmaceuticals, and Eli Lilly. WWC has received research support from GSK, UCB, Amgen, Pfizer, and BMS; consulting fees from GSK and Aurinia Pharmaceuticals; honoraria from GSK and Aurinia Pharmaceuticals for disease awareness presentations and curricula on achieving disease control and remission in SLE. RF has received research support and consulting fees from GSK. MBU has received research support from GSK; consulting fees from GSK and UCB; and speaker fees from GSK, Eli Lilly, and AstraZeneca. RvV has received research support for educational programmes and institutional grants from AstraZeneca, Pfizer, and UCB; consulting fees from AbbVie, AstraZeneca, Biogen, Biotest, BMS, Galapagos, Gilead, Janssen, Pfizer, Sanofi, Servier, UCB, and Vielabio; speaker fees from AbbVie, Galapagos, GSK, Janssen, Pfizer, and UCB; and research support from BMS, GSK Eli Lilly, and UCB. RBH, AvM, JCO-A, MO and DAR are employees of GSK and hold stocks and shares in the company. RBH is also an inventor for the following patents: US-20220195062-A1, US-11180569-B2, and US-20180265588-A1. KLC, JG, MD, YIG, DS and PPT were employees of GSK at the time of the study and hold stocks and shares in the company. NLF is a former employee and consultant for GSK and holds stocks in the company. YOT has received unrestricted research grants from GSK, Aurinia Pharmaceuticals, and Vifor Pharma; and consulting fees from Aurinia Pharmaceuticals, Novartis, GSK, Kezar Life Sciences Inc, Vifor Pharma, and Otsuka Pharmaceuticals (paid to Leiden University Medical Center)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
Published: 2024
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41. EULAR recommendations for the involvement of patient research partners in rheumatology research: 2023 update.

Author: de Wit M, Aouad K, Elhai M, Benavent D, Bertheussen H, Blackburn S, Böhm P, Duarte C, Falahee M, Karlfeldt S, Kiltz U, Mateus EF, Richards DP, Rodríguez-Carrio J, Sagen J, Shumnalieva R, Stones SR, Tas SW, Tillett W, Vieira A, Wilhelmer TC, Zabalan C, Primdahl J, Studenic P, and Gossec L
Subjects: Humans, Advisory Committees, Caregivers, Europe, Rheumatology standards, Biomedical Research standards, Patient Participation
Abstract: Background: Since the publication of the 2011 European Alliance of Associations for Rheumatology (EULAR) recommendations for patient research partner (PRP) involvement in rheumatology research, the role of PRPs has evolved considerably. Therefore, an update of the 2011 recommendations was deemed necessary., Methods: In accordance with the EULAR Standardised Operational Procedures, a task force comprising 13 researchers, 2 health professionals and 10 PRPs was convened. The process included an online task force meeting, a systematic literature review and an in-person second task force meeting to formulate overarching principles (OAPs) and recommendations. The level of agreement of task force members was assessed anonymously (0-10 scale)., Results: The task force developed five new OAPs, updated seven existing recommendations and formulated three new recommendations. The OAPs address the definition of a PRP, the contribution of PRPs, the role of informal caregivers, the added value of PRPs and the importance of trust and communication in collaborative research efforts. The recommendations address the research type and phases of PRP involvement, the recommended number of PRPs per project, the support necessary for PRPs, training of PRPs and acknowledgement of PRP contributions. New recommendations concern the benefits of support and guidance for researchers, the need for regular evaluation of the patient-researcher collaboration and the role of a designated coordinator to facilitate collaboration. Agreements within the task force were high and ranged between 9.16 and 9.96., Conclusion: The updated EULAR recommendations for PRP involvement are more substantially based on evidence. Together with added OAPs, they should serve as a guide for researchers and PRPs and will ultimately strengthen the involvement of PRPs in rheumatology research., Competing Interests: Competing interests: MdW: over the last 3 years, Stichting Tools has received fees for lectures or consultancy provided by Maarten de Wit from UCB, not related to this project. LG reports grants from AbbVie, Biogen, Lilly, Novartis, UCB, personal fees from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, non-financial support from AbbVie, Amgen, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB, outside the submitted work. KA: funded by EULAR grant RES005 this project; research grants: UCB; consulting fees: Novartis. ME: congress travel support from Janssen and AstraZeneca outside of the submitted work. DB: Speakers bureau: AbbVie, BMS, Galapagos, Janssen, Lilly, MSD. Research grants: Novartis. Consultancy: Sandoz, UCB. Part-time work in Savana Research. EFM has received consultancy fees from Boehringer Ingelheim Portugal outside of the submitted work, LPCDR has received fees for lectures or consultancy provided by Elsa Mateus from Lilly Portugal, GSK and Novartis, outside of the submitted work. SWT has received research funding, consultancy and/ or speaker fees from: Abbvie, Arthrogen, AstraZeneca, BMS, Celgene, Galapagos, Galvani bioelectronics, GSK, Lilly, MSD, Pfizer, Roche, and Sanofi-Genzyme, all outside the submitted work. WT has received research funding, consultancy and/ or speaker fees from: AbbVie, Amgen, BMS, Celgene, Eli-Lilly, GSK, Janssen, MSD, Novartis, Ono-Pharma, Pfizer and UCB all outside of the submitted work. HB, SB, PB, JP, CD, MF, SK, UK, DPR, JR-C, JS, RS, SRS, AV, T-CW, CZ and JP report no competing interests for this project., (© European Alliance of Associations for Rheumatology, EULAR 2024. Re-use permitted under CC BY-NC-ND. No commercial re-use. No derivatives. See rights and permissions. Published by BMJ on behalf of EULAR.)
Published: 2024
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42. 2023 EULAR classification criteria for hand osteoarthritis.

Author: Haugen IK, Felson DT, Abhishek A, Berenbaum F, Bierma-Zeinstra S, Dziedzic KS, Edwards JJ, Englund M, Hermann-Eriksen M, Herrero-Beaumont G, Hill C, Ishimori ML, Jonsson H, Karjalainen T, Leung YY, Maheu E, Mallen CD, Marshall M, Moe RH, Ramonda R, Ritschl V, Ritt MJ, Stamm TA, Szekanecz Z, van der Giesen F, van de Stadt LA, van der Meulen C, Wittoek R, Greibrokk E, Laheij H, and Kloppenburg M
Subjects: Humans, Hand Joints diagnostic imaging, Hand Joints pathology, Middle Aged, Sensitivity and Specificity, Male, Female, Finger Joint diagnostic imaging, Finger Joint pathology, Severity of Illness Index, Rheumatology standards, Aged, Self Report, Thumb diagnostic imaging, Thumb pathology, Consensus, Osteophyte diagnostic imaging, Osteoarthritis classification, Osteoarthritis diagnostic imaging, Osteoarthritis diagnosis, Radiography
Abstract: Objectives: The objective of this study is to develop classification criteria for overall hand osteoarthritis (OA), interphalangeal OA and thumb base OA based on self-reported data and radiographic features., Methods: The classification criteria sets were developed in three phases. In phase 1, we identified criteria that discriminated hand OA from controls. In phase 2, we used a consensus-based decision analysis approach to derive a clinician-based evaluation of the relative importance of the criteria. In phase 3, we refined the scoring system, determined the cut-offs for disease classification and compared the sensitivity and specificity of the European Alliance of Associations for Rheumatology (EULAR) criteria with the 1990 American College of Rheumatology (ACR) criteria., Results: In persons with hand symptoms and no other disease (including psoriasis) or acute injury that can explain the hand symptoms (mandatory criteria), hand OA can be classified based on age, duration of morning stiffness, number of joints with osteophytes and joint space narrowing, and concordance between symptoms and radiographic findings. Using a sum of scores based on each diagnostic element, overall hand OA can be classified if a person achieves 9 or more points on a 0-15 scale. The cut-off for interphalangeal OA and thumb base OA is 8 points. While the EULAR criteria demonstrated better sensitivity than the ACR criteria in the phase 1 data set, the performance of the two criteria sets was similar in two external cohorts., Conclusions: International experts developed the EULAR criteria to classify overall hand OA, interphalangeal OA and thumb base OA in clinical studies using a rigorous methodology., Competing Interests: Competing interests: IKH reports personal fees from Novartis and GSK; research grants from Pfizer and IMI-APPROACH (both paid to the institution); and unpaid role as secretary general of OARSI, all outside of the submitted work. AA reports institutional research grants from AstraZeneca and Oxford Immunotech; and personal fees from UpToDate (royalty), Springer (royalty), Cadilla Pharmaceuticals (lecture fees), NGM Bio (consulting), Limbic (consulting) and Inflazome (consulting), all outside of the submitted work. FB reports shares of 4P Pharma and 4Moving Biotech; personal fees from Boehringer Ingelgeim, Galapagos, Gilead, GSK, Merck Sereno, MSD, Novartis, Pfizer, Roche, Sanofi, Servier and Viatris; and research grant from TRB Chemedica, all outside the submitted work.Sita Bierma-Zeinstra reports research grants from Dutch Arthritis Association, EU Horizon, EU ERC and ZonMW (paid to institution), personal fees from Pfizer, Infirst healthcare, and paid role as deputy editor of Osteoarthritis and Cartilage, all outside of the submitted work.Krysia Dziedzic reports research grants from National Institute for Health and Care Research (NIHR); royalty/licence for Textbook for Rheumatology Therapists; payment for lecture at Australian Rheumatology Association Conference in May 2022; Implementation Advisor Fellows and Scholars Programme National Institute for Health and Care Excellence (UK 2019-22), Steering group member of NICE Implementation subgroup and Steering group member of OARSI Joint Effort initiative, all paid to institution and outside of the submitted work.Martin Englund reports personal fees from Cellcolabs AB (Sweden) and Key2 Compliance (Sweden), outside of the submitted work. Ying Ying Leung reports grants from National Medical Research Council (NMRC/CSA-INV/0022/2017), and personal fees from AbbVie, DKSH, Janssen, Novartis and Pfizer, outside of the submitted work. EM reports personal fees from Expanscience, Keyrus Life Science, Pierre Fabre, Rottapharm, MEDA-Mylan, Sublimed, TRB Chemedica, outside the submitted work. RR reports personal fees from from Novartis, AbbVie, Pfizer, MSD, Janssen, Lilly; support for attending EULAR, ACR and SIR; advisory board for Janssen, Novartis and Abbvie, outside of the submitted work. TAS reports grants and personal fees from AbbVie and Roche, and personal fees from Sanofi, Takeda and Novartis, outside the submitted work. ZS reports personal fees from AbbVie, Pfizer, Roche, Novartis, Lilly, Gedeon Richter, Sobi/Galapagos, outside of the submitted work. RW reports institutional research grants from Pfizer and Amgen, unrelated to this work, and is a Senior Clinical Investigator of the Research Foundation Flanders (Belgium) (FWO) (1803023N). MK reports consulting fees from Abbvie, Pfizer, Kiniksa, Flexion, Galapagos, Jansen, CHDR, Novartis and UCB (all paid to institution), outside of the submitted work. DF, JJE, MH-E, GH-B, CH, MLI, HJ, TK, CDM, MM, RHM, VR, MJPFR, FVG, LAS, CM, EG and HL report no conflicts of interest., (© European Alliance of Associations for Rheumatology, EULAR 2024. Re-use permitted under CC BY-NC-ND. No commercial re-use. No derivatives. See rights and permissions. Published by BMJ on behalf of EULAR.)
Published: 2024
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43. The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI study.

Author: Frazzei G, Cramer SHM, Landewé RBM, Maijer KI, Gerlag DM, Tak PP, de Vries N, van Baarsen LGM, van Vollenhoven RF, and Tas SW
Subjects: Humans, Male, Female, Middle Aged, Double-Blind Method, Treatment Outcome, Adult, Aged, Methylprednisolone administration & dosage, Methylprednisolone therapeutic use, Arthritis, Rheumatoid drug therapy, Rituximab therapeutic use, Rituximab administration & dosage, Patient Reported Outcome Measures, Antirheumatic Agents therapeutic use, Antirheumatic Agents administration & dosage, Quality of Life
Abstract: Objectives: Early treatment of individuals at risk of developing rheumatoid arthritis (RA-risk) in the preclinical phase has the potential to positively impact both patients and society by preventing disease onset and improving patients' quality of life. The PRAIRI study was a randomised, double-blind, placebo-controlled trial with the B-cell depleting agent rituximab (RTX), which resulted in a significant delay of arthritis development of up to 12 months in seropositive RA-risk individuals. Here, we report our findings on patient-reported outcomes (PROs) in this study population., Methods: Seventy-eight RA-risk individuals were treated with one single dose of either placebo (PBO) or 1000 mg RTX plus 100 mg methylprednisolone (MP) and anti-histamines, regardless of treatment allocation, as co-medication. Data on quality of life were collected at baseline and 1, 4, 6, 12 and 24 months using established PRO questionnaires (visual analogue scale (VAS) pain, health assessment questionnaire disability index (HAQ-DI) score, EuroQol five dimension (EQ-5D) and both physical and mental component score of the 36-item short-form heath survey (SF-36))., Results: No significant changes in quality of life over a 2 year follow-up were observed in at-risk individuals treated with RTX compared to PBO given the PRO scores at 24 months (mean difference±SEM: HAQ score=0.07±0.16; EQ-5D=-0.02±0.05; VAS pain=11.11±7.40). Furthermore, no significant effect of treatment on perceived arthritis severity at the time of clinically manifest disease (arthritis) was found., Conclusion: One single dose of RTX plus MP administered to RA-risk individuals does not have a meaningful and measurable positive effect on PROs after 2 years of follow-up and/or perceived disease severity at the time of arthritis development., Trial Registration Number: Trial registered at EU Clinical Trial Register, EudraCT Number: 2009-010955-29 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=Prevention+of+RA+by+B+cell+directed+therapy)., Competing Interests: Competing interests: GF, SHMC, RBML, KIM, DMG, PPT, NdV and LGMvB report no conflict of interest. RFvV reports institutional grants from AstraZeneca, BMS, Galapagos, MSD, Novartis, Pfizer, Roche, Sanofi and UCB, as well as institutional fees from AbbVie, AstraZeneca, Biogen, BSM, Galapagos, GSK, Janssen, Pfizer, RemeGen and UCB, all outside the submitted work. SWT reports institutional grants from GSK, Lilly, Celgene, Pfizer, Roche, AstraZeneca, Galapagos, Citryll and Galvani bioelectronics, as well as institutional fees from NovoNordisk, Pfizer, AbbVie and UCB, all outside the submitted work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
Published: 2024
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44. Anti-modified protein antibodies can be detected in saliva, but not in intestinal secretions of seropositive rheumatoid arthritis patients - evidence of site-specific mucosal autoantibody secretion in RA.

Author: Derksen VFAM, Martinsson K, van Mourik AG, Wagenaar CA, Toes REM, Walrabenstein W, Sjöberg D, van Schaardenburg D, Huizinga TWJ, Kastbom A, Svärd A, and van der Woude D
Abstract: Objective: Anti-citrullinated protein antibodies (ACPA) have been detected in sputum and saliva, indicating that anti-modified protein antibodies (AMPA) can be produced at mucosal sites in rheumatoid arthritis (RA) patients. However, the body's largest mucosal compartment, the gut, has not yet been examined. We therefore investigated the presence of several AMPA (antibodies against citrullinated (ACPA), carbamylated (anti-CarP) and acetylated (AAPA) proteins) at different mucosal sites, including the intestinal tract., Methods: Paired fecal/ileal wash, saliva and serum samples of RA patients and healthy volunteers were collected in two independent cohorts. Data involving feces was replicated in a third cohort. In these secretions AMPA were analyzed using in-house ELISA with unmodified peptides as control. In fecal samples total IgA and anti-E. coli IgA were measured., Results: ACPA, anti-CarP and AAPA IgA were measurable in saliva of seropositive RA patients (prevalence 9-40%). No AMPA could be detected in feces. IgA was present since total IgA and anti-E. coli IgA was detectable in feces of ACPA-positive RA patients and healthy donors. Results were confirmed in another cohort using colonoscopically collected ileal wash samples., Conclusion: Our study shows the presence of ACPA, anti-CarP and AAPA IgA in saliva of ACPA-seropositive RA patients. However, no AMPA could be detected in feces/ileal wash samples of these patients, although our assays were able to measure other antigen-specific antibodies. These data suggest that mucosal autoantibody secretion may occur in the oral mucosa of RA patients, while no evidence could be found for this process in the lower gastro-intestinal tract., (This article is protected by copyright. All rights reserved.)
Published: 2024
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45. Circulating Baseline CXCR3 + Th2 and Th17 Cell Proportions Correlate With Trabecular Bone Loss After 48 Weeks of Biological Treatment in Early Rheumatoid Arthritis.

Author: Scheffler JM, Drevinge C, Lindholm C, Gjertsson I, Lend K, Lund Hetland M, Østergaard M, Uhlig T, Schrumpf Heiberg M, Haavardsholm EA, Nurmohamed MT, Lampa J, Sokka-Isler T, Nordström D, Hørslev-Petersen K, Gudbjornsson B, Gröndal G, van Vollenhoven R, Carlsten H, Lorentzon M, Hultgård Ekwall AK, Rudin A, and Islander U
Abstract: Objective: The high prevalence of osteoporosis in rheumatoid arthritis (RA) is due to inflammation that stimulates differentiation of osteoclasts, a process involving circulating monocytes and T cell-derived factors. The aim of this study was to evaluate relations between circulating monocytes, T cell subsets, and changes in bone characteristics before and after treatment with biological disease-modifying antirheumatic drugs (bDMARDs) in RA., Methods: Thirty patients with untreated early RA who met the American College of Rheumatology/EULAR 2010 criteria were included. Data were collected before and 48 weeks after treatment with methotrexate (MTX) together with one of three bDMARDs (abatacept, tocilizumab, or certolizumab pegol). Disease activity was measured using the Clinical Disease Activity Index, swollen or tender joint counts, C-reactive protein levels, and erythrocyte sedimentation rates. Proportions of monocyte and CD4 + T cell subsets in blood samples were analyzed by flow cytometry. Bone densitometry was performed using high-resolution peripheral quantitative computed tomography (HR-pQCT)., Results: HR-pQCT revealed an overall decrease in cortical (P = 0.009) and trabecular (P = 0.034) bone mineral density, although a subset of patients showed no bone loss after 48 weeks of treatment. The overall bone loss was not associated with age, body mass index, sex, intraarticular glucocorticoid injections, or baseline disease activity. Loss of trabecular bone volume fraction correlated with high proportions of circulating CXCR3 + Th2 cells (r = -0.38, P = 0.04) and CXCR3 + Th17 cells (r = -0.36, P = 0.05) at baseline. Similarly, no loss of trabecular bone volume fraction correlated with high proportions of regulatory T cells (r = 0.4, P = 0.03) at baseline. However, the associations were not significant when corrected for confounders and multiple testing., Conclusion: MTX together with bDMARDs efficiently reduce disease activity but only prevent bone loss in a subset of patients with RA after 48 weeks of treatment. The correlations of circulating baseline T helper cell and regulatory T cell populations with trabecular bone changes suggest a potential novel role for these cells in systemic bone homeostasis during early RA., (© 2024 The Author(s). ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
Published: 2024
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46. Methotrexate treatment hampers induction of vaccine-specific CD4 T cell responses in patients with IMID.

Author: Kummer LYL, Fernández Blanco L, Kreher C, Bos A, Kuijper LH, Verstegen NJM, van de Sandt CE, Konijn VAL, Duurland MC, Menage C, Jorritsma T, Steenhuis M, Hagen RR, van den Dijssel J, de Jongh R, Ashhurst T, van Gils MJ, Garcia-Vallejo JJ, Claireaux M, Stalman EW, van Dam KPJ, Wieske L, Boekel L, Wolbink G, Tas SW, Rispens T, Kuijpers TW, Eftimov F, van Ham SM, and Ten Brinke A
Subjects: Humans, Male, Middle Aged, Female, Aged, Adult, Antirheumatic Agents therapeutic use, Vaccination, Methotrexate therapeutic use, CD4-Positive T-Lymphocytes immunology, COVID-19 immunology, COVID-19 prevention & control, SARS-CoV-2 immunology, COVID-19 Vaccines immunology, COVID-19 Vaccines administration & dosage, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid immunology, B-Lymphocytes immunology, B-Lymphocytes drug effects
Abstract: Objectives: Methotrexate (MTX) is one of the most commonly used medications to treat rheumatoid arthritis (RA). However, the effect of MTX treatment on cellular immune responses remains incompletely understood. This raises concerns about the vulnerability of these patients to emerging infections and following vaccination., Methods: In the current study, we investigated the impact of MTX treatment in patients with immune-mediated inflammatory disease on B and CD4 T cell SARS-CoV-2 vaccination responses. Eighteen patients with RA and two patients with psoriatic arthritis on MTX monotherapy were included, as well as 10 patients with RA without immunosuppressive treatment, and 29 healthy controls. CD4 T and B cell responses were analysed 7 days and 3-6 months after two SARS-CoV-2 messenger RNA vaccinations. High-dimensional flow cytometry analysis was used to analyse fresh whole blood, an activation-induced marker assay to measure antigen-specific CD4 T cells, and spike probes to study antigen-specific B cells., Results: Seven days following two SARS-CoV-2 vaccinations, total B and T cell counts were similar between MTX-treated patients and controls. In addition, spike-specific B cell frequencies were unaffected. Remarkably, the frequency of antigen-specific CD4 T cells was reduced in patients using MTX and correlated strongly with anti-RBD IgG antibodies. These results suggest that decreased CD4 T cell activity may result in slower vaccination antibody responses in MTX-treated patients., Conclusion: Taken together, MTX treatment reduces vaccine-induced CD4 T cell activation, which correlates with lower antibody responses., Trial Registration Number: NL8900., Competing Interests: Competing interests: FE, GW, SMvH and TWK report (governmental) grants from ZonMw to study immune response after SARS-Cov-2 vaccination in auto-immune diseases. FE also reports grants from Prinses Beatrix Spierfonds, CSL Behring, Kedrion, Terumo BCT, Grifols, Takeda Pharmaceutical and GBS-CIDP Foundation; consulting fees from UCB Pharma and CSl Behring; honoraria from Grifols. All other authors report no disclosures relevant to the manuscript., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2024
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47. Truth and dare: patients dare to tell the truth when using PROMs in clinical practice.

Author: Haverman L, Luijten MAJ, Blackford AL, Absolom K, Basch EM, van Rossum MAJ, Engelen V, Grootenhuis MA, Velikova G, and Snyder C
Abstract: Purpose: As patient-reported outcome measures (PROMs) are increasingly used in clinical practice for screening, monitoring, and management, the potential for response bias has been raised (e.g., over-reporting problems for attention, under-reporting to avoid treatment changes/discontinuation). We investigated whether patients systematically bias their responses when they know clinicians will review their PROM results., Methods: We conducted secondary analyses of three experimental studies evaluating PROMs in adult and pediatric care. Prior to PROM completion, intervention group patients were informed that the results would be shown to their clinicians ("feedback" arm), whereas control group patients were told that their clinicians would not see their responses ("no feedback" arm). Independent sample t-tests compared the "feedback" and "no feedback" arms' PROM scores at baseline. Effect sizes and 95% confidence intervals were estimated using Cohen's d statistics with Hedges' g correction, and effect sizes > 0.50 were considered clinically relevant., Results: Across the 29 domains assessed in the three studies, no between-arm differences reached an effect size of ± 0.50. Only 3/29 effect sizes exceeded ± 0.30. The confidence intervals for 14 domains included ± 0.50, with 4 favoring the "no feedback" arm and 10 favoring the "feedback" arm. Two domains reached statistical significance, one favoring the "no feedback" arm and one favoring the "feedback" arm., Conclusion: This study does not support the hypothesis that patients systematically bias their PROM responses if they know that clinicians will see their results. These findings support using PROMs in clinical practice as a valid mechanism to promote patient-centered care., (© 2024. The Author(s).)
Published: 2024
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48. Prevalence and incidence of uveitis in patients with spondyloarthritis: the impact of the biologics era. Data from International ASAS-COMOSPA Study.

Author: Maldonado-Ficco H, López-Medina C, Perez-Alamino R, Waimann CA, Maldonado-Cocco JA, Moltó A, Dougados M, Landewé RBM, van der Heijde D, and van Den Bosch F
Abstract: Objectives: Uveitis is a common extra-musculoskeletal manifestation in Spondyloarthritis (SpA). The aim of this study was to analyze the prevalence of uveitis in SpA patients, its association with geographical areas and to determine whether its incidence was different before and after the biological era., Methods: ASAS-COMOSPA is a retrospective study that includes patients fulfilling ASAS SpA classification criteria from 22 countries. The overall prevalence of uveitis was calculated, and factors associated with the onset of a first episode of uveitis were evaluated using a Cox regression. A Log-Rank test was performed to compare the new onset of uveitis in the no biological era (SpA onset before 2000) vs biological era (SpA onset after 2000)., Results: 3984 patients were included. The likelihood of presenting a first uveitis episode increased over time, from a prevalence of 10.5% (95%CI 9.5%-11.4%) at the time of the SpA diagnosis to 46.6% (41.6%-51.5%) after 30 years since the SpA diagnosis. HLA-B27 positivity, family history of uveitis, peripheral enthesitis and IBD were associated with higher risk of uveitis. Patients with SpA disease onset after year 2000 showed a lower prevalence of uveitis compared with disease onset before year 2000 (8.2% vs 25.5%, p< 0.01), as well as a lower incidence (2.8 per 100 PY vs 6.1 per 100 PY, respectively)., Conclusion: In our study the risk of having suffered from at least one episode of uveitis ranged from 10% at the time of the diagnosis of axSpA to 47% after 30 years of disease duration. Patients with disease onset after biologic therapy introduction showed a significantly lower prevalence and incidence of first episodes of uveitis., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Published: 2024
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49. Effect of a multidisciplinary lifestyle intervention on body composition in people with osteoarthritis: Secondary analysis of the "Plants for Joints" randomized controlled trial.

Author: Wagenaar CA, Walrabenstein W, de Jonge CS, Bisschops M, van der Leeden M, van der Esch M, Weijs PJM, Troelstra MA, Korteweg MA, Nederveen AJ, and van Schaardenburg D
Abstract: Objective: The Plants for Joints (PFJ) intervention significantly improved pain, stiffness, and physical function, and metabolic outcomes, in people with metabolic syndrome-associated osteoarthritis (MSOA). This secondary analysis investigated its effects on body composition., Method: In the randomized PFJ study, people with MSOA followed a 16-week intervention based on a whole-food plant-based diet, physical activity, and stress management, or usual care. For this secondary analysis, fat mass, muscle mass, and bone mineral density were measured using dual-energy X-ray absorptiometry (DEXA) for all participants. Additionally, in a subgroup ( n = 32), hepatocellular lipid (HCL) content and composition of visceral adipose tissue (VAT) were measured using magnetic resonance spectroscopy (MRS). An intention-to-treat analysis with a linear-mixed model adjusted for baseline values was used to analyse between-group differences., Results: Of 66 people randomized, 64 (97%) completed the study. The PFJ group experienced significant weight loss (-5.2 kg; 95% CI -6.9, -3.6) compared to controls, primarily from fat mass reduction (-3.9 kg; 95% CI -5.3 to -2.5). No significant differences were found in lean mass, muscle strength, or bone mineral density between groups. In the subgroup who underwent MRI scans, the PFJ group had a greater reduction in HCL (-6.5%; 95% CI -9.9, 3.0) compared to controls, with no observed differences in VAT composition., Conclusion: The PFJ multidisciplinary intervention positively impacted clinical and metabolic outcomes, and appears to significantly reduce body fat, including liver fat, while preserving muscle mass and strength., Competing Interests: Authors CAW, WW, and DvS hold shares in Plants for Health, a limited liability company, which aims to have a positive impact on society and the environment and provide an adapted version of the Plants for Joints program as an additional treatment option for people with rheumatic conditions. All other authors report no conflict of interest., (© 2024 The Author(s).)
Published: 2024
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50. Cost-utility analysis of longstanding exercise therapy versus usual care in people with rheumatoid arthritis and severe functional limitations.

Author: Teuwen M, van Weely S, van den Ende C, van Wissen M, Vliet Vlieland T, Peter WF, den Broeder AA, van Schaardenburg D, Gademan M, and van den Hout WB
Abstract: Objective: To evaluate the cost-effectiveness of longstanding personalized exercise therapy compared with usual care in people with rheumatoid arthritis (RA) and severe functional disability., Method: In this cost-utility analysis of a randomized controlled trial (n = 215), with 1 year follow-up, the study population comprised individuals with RA and reported severe difficulties in performing basic daily activities. Assessments were at baseline, 12, 26, and 52 weeks, with measurements of costs including medical and non-medical costs as recorded by patients and healthcare providers. Quality-adjusted life-years (QALYs) were estimated using the EuroQol 5 dimensions 5 levels (EQ-5D-5L) and EuroQol Visual Analogue Scale (EQ-VAS). Costs and QALY differences were analysed according to the intention-to-treat principle using cost-effectiveness acceptability curves., Results: The 1 year societal costs were non-significantly in favour of the usual care group, with a small difference of €180 [95% confidence interval (CI) €-4493 to €4852]. The QALYs were non-significantly in favour of the intervention group, by 0.02 according to the EQ-5D-5L (95% CI -0.05 to 0.09) and by 0.04 according to the EQ-VAS (95% CI 0.00 to 0.08). For a willingness-to-pay threshold of €50 000 per QALY, the intervention was the cost-effective strategy with 60% certainty., Conclusion: This economic evaluation showed no clear economic preference for either group, as the intervention costs were higher in the intervention group, but partly compensated by other cost savings and improved QALYs. Despite severe RA, patients had better clinical outcomes compared with usual care, suggesting no economic reasons to refrain from exercise therapy., Trial Registration Number: Netherlands Trial Register NL8235, included in the International Clinical Trial Registry Platform (ICTRP) (https://trialsearch.who.int/Trial2.aspx?TrialID=NL8235).
Published: 2024
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