33 results on '"Fagerli KM"'
Search Results
2. OP0109 Is mental health comparabale in rheumatoid and psoriatic arthritis patients? a comparative analysis of real life longitudinal data from the nor-dmard study
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Michelsen, B, primary, Lie, E, additional, Fagerli, KM, additional, Kristianslund, EK, additional, Hammer, HB, additional, Haugeberg, G, additional, and Kvien, TK, additional
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- 2017
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3. FRI0490 Real-life effectiveness of tnf inhibitors in psoriatic arthritis: are changing national policies on choice of tnf inhibitor reflected in response to treatment?
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Kristianslund, EK, primary, Fagerli, KM, additional, Lie, E, additional, Wierød, A, additional, Kalstad, S, additional, Rødevand, E, additional, Krøll, F, additional, Mielnik, P, additional, Kvien, TK, additional, and Olsen, IC, additional
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- 2017
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4. Change in different classes of chronic back pain suspicious of axial spondyloarthritis: a latent transition analysis of the SPACE cohort.
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Bosch P, Sepriano A, Marques ML, van der Heijde D, Landewé R, van Lunteren M, de Bruin L, de Hooge M, Bastiaenen C, Exarchou S, Ramonda R, Fagerli KM, van Gaalen FA, and Ramiro S
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- Humans, Male, Female, Adult, Middle Aged, Latent Class Analysis, Cohort Studies, Disease Progression, Spondylarthritis diagnosis, Spondylarthritis classification, Spondylarthritis complications, Back Pain etiology, Back Pain diagnosis, Chronic Pain etiology, Chronic Pain diagnosis, Axial Spondyloarthritis diagnosis, Axial Spondyloarthritis etiology
- Abstract
Objectives: To follow up four previously identified classes 'pure axial spondyloarthritis' (axSpA) ('axial'), 'axSpA with peripheral signs' ('inflammatory back pain+peripheral'), 'axSpA at risk' and 'no spondyloarthritis' ('no SpA'). They reflect the expert-opinion-free construct or 'Gestalt' of chronic back pain suspicious of axSpA. The aim was to assess participants' transitions between these classes over time., Methods: Participants with chronic back pain of ≤2 years duration, suspicious of axSpA from the SPondyloArthritis Caught Early cohort were analysed. Latent class (LCA) and latent transition analysis (LTA) using clinical, laboratory and imaging data at baseline and 2 years were calculated. Conditional and marginal probabilities were obtained, reflecting the probability of a spondyloarthritis feature in a class and the probability of the participant's class membership, respectively. Transitional probabilities were extracted revealing potential switches across classes. The analyses were performed in all participants using imputations for missing data and in participants with full data at baseline and 2 years., Results: Baseline and 2 years LCA models were constructed for 702 participants, resulting in the same four-class model as previously described. LTA revealed only a 3% transition from the 'no SpA' to the 'at-risk' class from baseline to 2 years with all other participants remaining in their initially assigned class. Sensitivity analysis on 384 participants with complete data at both baseline and 2 years showed similar results, underlining the model's robustness., Conclusions: Transitions between the four classes over 2 years were basically inexistent, highlighting the unlikelihood of developing new class-defining features of axSpA after an initial clinical workup., Competing Interests: Competing interests: PB has received travelling grants and adds board fees from Janssen, speaker fees from Janssen and AbbVie and projects grants from Pfizer; AS has received speaking and/or consulting fees from AbbVie, Novartis, UCB and Lilly. DvdH has received consulting fees from AbbVie, Argenx, BMS, Galapagos, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma and is an associate editor of Annals Rheumatic Diseases, editorial board member of Journal of Rheumatology and RMD Open, Advisor Assessment of Axial Spondyloarthritis international Society and director of Imaging Rheumatology bv. RL has received honoraria for lectures and advisory boards from AbbVie, Galapagos, Janssen, Lilly, Novartis, Pfizer and UCB. RL is owner of Rheumatology Consultancy BV. MdH has received consultancy fees of UCB Pharma. SE has received consultancy fees from AbbVie, Amgen, Janssen, Novartis, UCB Pharma, Eli Lilly and research support from UCB Pharma. RR has received travelling grants, consulting and/or speaking fees, Advisory Boards fees from Abbvie, Novartis, Janssen, Lilly, MSD, Pfizer, and UCB. FvG reports research grants from Stichting vrienden van Sole Mio, Stichting ASAS, research grants and consultancy fees from Novartis, research grants from UCB, fees from MSD, consultancy fees from Abb Vie, fees from Bristol Myers Squibb and Eli Lilly, is a full time employee of the LUMC and member of the ASAS EC and the ASAS treasurer. SR has received grants from AbbVie, Galapagos, MSD, Novartis, Pfizer, UCB and consultancy fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Pfizer, UCB, Sanofi. The other authors have not declared any COI., (© 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.)
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- 2024
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5. Can rheumatologists unequivocally diagnose axial spondyloarthritis in patients with chronic back pain of less than 2 years duration? Primary outcome of the 2-year SPondyloArthritis Caught Early (SPACE) cohort.
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Marques ML, Ramiro S, van Lunteren M, Stal RA, Landewé RB, van de Sande M, Fagerli KM, Berg IJ, van Oosterhout M, Exarchou S, Ramonda R, van der Heijde D, and van Gaalen FA
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- Humans, Male, Rheumatologists, HLA-B27 Antigen, Back Pain diagnosis, Magnetic Resonance Imaging methods, Sacroiliitis diagnostic imaging, Spondylarthritis diagnosis, Spondylarthritis diagnostic imaging, Axial Spondyloarthritis, Spondylitis, Ankylosing diagnosis
- Abstract
Objectives: To investigate the prevalence of axial spondyloarthritis (axSpA) in patients with chronic back pain (CBP) of less than 2 years (2y) duration referred to the rheumatologist, the development of diagnosis over time, and patient characteristics of those developing definite (d-)axSpA over 2y., Methods: We analysed the 2y data from SPondyloArthritis Caught Early, a European cohort of patients (<45 years) with CBP (≥3 months, ≤2y) of unknown origin. The diagnostic workup comprised evaluation of clinical SpA features, acute phase reactants, HLA-B27, radiographs and MRI (sacroiliac joints and spine), with repeated assessments. At each visit (baseline, 3 months, 1y and 2y), rheumatologists reported a diagnosis of axSpA or non-axSpA with level of confidence (LoC; 0- not confident at all to 10- very confident )., Main Outcome: axSpA diagnosis with LoC≥7 ( d-axSpA ) at 2y., Results: In 552 patients with CBP, d-axSpA was diagnosed in 175 (32%) at baseline and 165 (30%) at 2y. Baseline diagnosis remained rather stable: at 2y, baseline d-axSpA was revised in 5% of patients, while 8% 'gained' d-axSpA . Diagnostic uncertainty persisted in 30%. HLA-B27+ and baseline sacroiliitis imaging discriminated best 2y- d-axSpA versus 2y- d-non-axSpA patients. Good response to non-steroidal anti-inflammatory drugs and MRI-sacroiliitis most frequently developed over follow-up in patients with a new d-axSpA diagnosis. Of the patients who developed MRI-sacroiliitis, 7/8 were HLA-B27+ and 5/8 male., Conclusion: A diagnosis of d-axSpA can be reliably made in nearly one-third of patients with CBP referred to the rheumatologist, but diagnostic uncertainty may persist in 5%-30% after 2y. Repeated assessments yield is modest, but repeating MRI may be worthwhile in male HLA-B27+ patients., Competing Interests: Competing interests: MLM: none. SR: Research Grants—AbbVie, Galapagos, MSD, Novartis, Pfizer, UCB. Consultancy—AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sanofi, UCB. MvL: none. RS: none. RBML: Consultancy—AbbVie, Eli-Lilly, Janssen, Galapagos, Gilead, Novartis, Pfizer, UCB. Director of Rheumatology Consultancy BVD. MvdS: Speaker—Janssen, Novartis, UCB. Consultancy—Abbvie, Eli Lilly, Novartis, UCB. Research Grants:Janssen, Novartis, UCB. KMF: none. IJB: none. MvO: none. SE: Consultancy—AbbVie, Janssen, Novartis, and UCB. RR: Consultancy: Abbvie, Eli-Lilly, Janssen, Novartis, Pfizer, UCB, Amgen. DvdH: Consultancy—AbbVie, ArgenX, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma. Director of Imaging Rheumatology bv. FAvG: Research Grants -Novartis. Consultancy—MSD, AbbVie, Novartis and BMS., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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6. Patient-reported outcomes in axial spondyloarthritis and psoriatic arthritis patients treated with secukinumab for 24 months in daily clinical practice.
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Christiansen SN, Horskjær Rasmussen S, Pons M, Michelsen B, Glintborg B, Gudbjornsson B, Grondal G, Vencovsky J, Loft AG, Rotar Z, Pirkmajer KP, Nissen MJ, Baranová J, Macfarlane GJ, Jones GT, Iannone F, Caporali R, Laas K, Vorobjov S, Giuseppe DD, Olofsson T, Provan SA, Fagerli KM, Castrejon I, Otero-Varela L, van de Sande M, van der Horst-Bruinsma I, Nordström D, Kuusalo L, Bernardes M, Hetland ML, Østergaard M, and Midtbøll Ørnbjerg L
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- Humans, Treatment Outcome, Pain, Arthritis, Psoriatic drug therapy, Axial Spondyloarthritis, Antibodies, Monoclonal, Humanized
- Abstract
Objectives: In patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) initiating secukinumab, we aimed to assess and compare the proportion of patients achieving 6-, 12- and 24-month patient-reported outcomes (PRO) remission and the 24-month retention rates., Patients and Methods: Patients with axSpA or PsA from 16 European registries, who initiated secukinumab in routine care were included. PRO remission rates were defined as pain, fatigue, Patient Global Assessment (PGA) ≤2 (Numeric Rating Scale (NRS) 0-10) and Health Assessment Questionnaire (HAQ) ≤0.5, for both axSpA and PsA, and were calculated as crude values and adjusted for drug adherence (LUNDEX). Comparisons of axSpA and PsA remission rates were performed using logistic regression analyses (unadjusted and adjusted for multiple confounders). Kaplan-Meier plots with log-rank test and Cox regression analyses were conducted to assess and compare secukinumab retention rates., Results: We included 3087 axSpA and 3246 PsA patients initiating secukinumab. Crude pain, fatigue, PGA and HAQ remission rates were higher in axSpA than in PsA patients, whereas LUNDEX-adjusted remission rates were similar. No differences were found between the patient groups after adjustment for confounders. The 24-month retention rates were similar in axSpA vs. PsA in fully adjusted analyses (HR [95 %CI] = 0.92 [0.84-1.02])., Conclusion: In this large European real-world study of axSpA and PsA patients treated with secukinumab, we demonstrate for the first time a comparable effectiveness in PRO remission and treatment retention rates between these two conditions when adjusted for confounders., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sara Nysom Christiansen, Simon Horskjær Rasmussen, Lykke Midtbøll Ørnbjerg: research grant from Novartis; Marion Pons: research grant from Novartis and speaker fees from Sandoz; Brigitte Michelsen: research grant from Novartis and the centre for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY) is funded as a Centre for Clinical Treatment Research by The Research Council of Norway (project 328,657); Bente Glintborg: research grants from Pfizer, Abbvie, BMS, Sandoz; Bjorn Gudbjornsson: consulting fees from Novartis and speaker fees from Novartis, Nordic-Pharma; Gerdur Grondal: none; Jiri Vencovsky: research grant from Abbvie, consulting fees from Abbvie, Argenx, Boehringer, Eli Lilly, Gilead, Octapharma, Pfizer, UCB and speaker fees from Abbvie, Biogen, Boehringer, Eli Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Werfen; Anne Gitte Loft: research grant from Novartis andspeaking and/or consulting fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, paid instructor from Pfizer; Ziga Rotar: consulting fees from Abbvie, Novartis, Eli Lilly, Pfizer, Janssen and speaker fees from Abbvie, Amgen, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen; Katja Perdan Pirkmajer: consulting fees from Abbvie, Novartis, Medis, Eli Lilly, Pfizer, Boehringer Ingelheim and speaker fees from Abbvie, Novartis, MSD, Medis, Eli Lilly, Pfizer, Lek, Janssen; Michael J. Nissen: research grant from Pfizer andconsulting and/or speaker fees from Abbvie, Eli Lilly, Janssens, Novartis, Pfizer; Jana Baranova: none; Gary J. Macfarlane: research grant from GSK; Gareth T.Jones: research grants from Abbvie, Pfizer, UCB, Amgen, GSK and speaker fees from Janssen; Florenzo Iannone: research grant from BMS, Galapagos, Pfizer and consulting and/or speakers fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB; Roberto Caporali: consulting and/or speaker fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB; Karin Laas: research grant from Abbvie, Johnson and Johnson, Novartis, Pfizer; Sigrid Vorobjov: none; Daniella Di Giuseppe: none; Tor Olofsson: none; Sella Aarrestad Provan: Research grant from Boehringer Ingelheim and consulting fees from Boehringer Ingelheim; Karen Minde Fagerli: none; Isabel Castrejon: consulting and speaker fees from BMS, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer, GSK; Lucia Otero-Varela: None; Marleen Van de Sande: research grants from UCB, Janssen, Novartis, Eli Lilly, consulting fees from Novartis, Abbvie, Eli Lilly UCB and speaker fees from Novartis, UCB, Janssen; Irene van der Horst-Bruinsma: Unrestricted Grants received for investigator initiated studies from MSD, Pfizer, AbbVie, UCB. Fees received for lectures from BMS, AbbVie, Pfizer, MSD, UCB, consulting fees from Abbvie, UCB, MSD, Novartis, Lilly and speaker fees from UCB; Dan Nordström: research grant from MSD, consulting fees from Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, UCB, and speaker fees from Novartis, Pfizer, UCB; Laura Kuusalo: consulting fees from Gilead, Pfizer and speaker fees from Abbvie, Lilly, Medac, Orion, Pfizer, UCB; Miguel Bernades: none; Merete Lund Hetland: Research grants from Novartis, Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis, Nordforsk, consulting fees from Abbvie, chaired the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies and speaker fees from Pfizer, Medac, Sandoz; Mikkel Østergaard: Research grant from Abbvie, BMS, Merck, Novartis and UCB and consulting and/or speaker fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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7. Patient-Reported Outcomes (PROs) and PRO Remission Rates in 12,262 Biologic-Naïve Patients With Psoriatic Arthritis Treated With Tumor Necrosis Factor Inhibitors in Routine Care.
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Ørnbjerg LM, Rugbjerg K, Georgiadis S, Rasmussen SH, Jacobsson L, Loft AG, Iannone F, Fagerli KM, Vencovsky J, Santos MJ, Möller B, Pombo-Suarez M, Rotar Z, Gudbjornsson B, Cefle A, Eklund K, Codreanu C, Jones G, van der Sande M, Wallman JK, Sebastiani M, Michelsen B, Závada J, Nissen MJ, Sanchez-Piedra C, Tomšič M, Love TJ, Relas H, Mogosan C, Hetland ML, and Østergaard M
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- Male, Humans, Female, Tumor Necrosis Factor Inhibitors therapeutic use, Treatment Outcome, Patient Reported Outcome Measures, Pain drug therapy, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic diagnosis, Antirheumatic Agents therapeutic use, Biological Products therapeutic use
- Abstract
Objective: To evaluate patient-reported outcomes (PROs) after initiation of tumor necrosis factor inhibitor (TNFi) treatment in European real-world patients with psoriatic arthritis (PsA). Further, to investigate PRO remission rates across treatment courses, registries, disease duration, sex, and age at disease onset., Methods: Visual analog scale or numerical rating scale scores for pain, fatigue, patient global assessment (PtGA), and the Health Assessment Questionnaire-Disability Index (HAQ-DI) from 12,262 patients with PsA initiating a TNFi in 13 registries were pooled. PRO remission rates (pain ≤ 1, fatigue ≤ 2, PtGA ≤ 2, and HAQ-DI ≤ 0.5) were calculated for patients still on the treatment., Results: For the first TNFi, median pain score was reduced by approximately 50%, from 6 to 3, 3, and 2; as were fatigue scores, from 6 to 4, 4, and 3; PtGA scores, from 6 to 3, 3, and 2; and HAQ-DI scores, from 0.9 to 0.5, 0.5, and 0.4 at baseline, 6, 12, and 24 months, respectively. Six-month Lund Efficacy Index (LUNDEX)-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 24%, 31%, 36%, and 43% (first TNFi); 14%, 19%, 23%, and 29% (second TNFi); and 9%, 14%, 17%, and 20% (third TNFi), respectively. For biologic-naïve patients with disease duration < 5 years, 6-month LUNDEX-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 22%, 28%, 33%, and 42%, respectively. Corresponding rates for patients with disease duration > 10 years were 27%, 32%, 41%, and 43%, respectively. Remission rates were 33%, 40%, 45%, and 56% for men and 17%, 23%, 24%, and 32% for women, respectively. For patients aged < 45 years at diagnosis, 6-month LUNDEX-adjusted remission rate for pain was 29% vs 18% for patients ≥ 45 years., Conclusion: In 12,262 biologic-naïve patients with PsA, 6 months of treatment with a TNFi reduced pain by approximately 50%. Marked differences in PRO remission rates across treatment courses, registries, disease duration, sex, and age at onset of disease were observed, emphasizing the potential influence of factors other than disease activity on PROs., (Copyright © 2024 by the Journal of Rheumatology.)
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- 2024
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8. Sex Differences in the Effectiveness of First-Line Tumor Necrosis Factor Inhibitors in Psoriatic Arthritis: Results From the European Spondyloarthritis Research Collaboration Network.
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Hellamand P, van de Sande MGH, Ørnbjerg LM, Klausch T, Eklund KK, Relas H, Santos MJ, Vieira-Sousa E, Loft AG, Glintborg B, Østergaard M, Lindström U, Wallman JK, Michelsen B, Fagerli KM, Castrejón I, Gudbjornsson B, Love TJ, Vencovský J, Nekvindová L, Rotar Ž, Tomšič M, Díaz-González F, Kenar G, Tuğsal HY, Iannone F, Ramonda R, Codreanu C, Mogosan C, Nissen MJ, Möller B, Hetland ML, and van der Horst-Bruinsma IE
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- Humans, Female, Male, Tumor Necrosis Factor Inhibitors therapeutic use, Sex Characteristics, Tumor Necrosis Factor-alpha, Treatment Outcome, Arthritis, Psoriatic drug therapy, Antirheumatic Agents therapeutic use, Spondylarthritis drug therapy
- Abstract
Objective: Women with psoriatic arthritis (PsA) may have reduced tumor necrosis factor inhibitor (TNFi) effectiveness compared to men. We examined sex differences in treatment response and retention rates during 24 months of follow-up among patients with PsA initiating their first TNFi., Methods: Data from patients with PsA across 13 European Spondyloarthritis Research Collaboration Network registries starting their first TNFi were pooled. Logistic regression was used to analyze the association between sex and treatment response using low disease activity (LDA) according to the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) (<3.2) at six months as the primary outcome. Analyses were adjusted for age, country, conventional synthetic disease-modifying antirheumatic drug treatment, and TNFi start year. Retention rates were explored using the Kaplan-Meier estimator., Results: We analyzed the treatment response of 7,679 patients with PsA (50% women) with available data on LDA at six months. At baseline, women and men had similar characteristics, including mean DAS28-CRP (women vs men, 4.4 [SD 1.2] vs 4.2 [SD 1.2]), though patient-reported outcome measures were worse in women. At six months, 64% of women and 78% of men had LDA (relative risk [RR] 0.82; 95% confidence interval [CI] 0.80-0.84). This difference was similar after adjustment (RR 0.83; 95% CI 0.81-0.85). TNFi retention rates were evaluated in 17,842 patients with PsA. Women had significantly lower retention rates than men at all time points (women 79%, 64%, and 50% vs men 88%, 77%, and 64% at 6, 12, and 24 months, respectively)., Conclusion: Despite comparable disease characteristics at baseline, women with PsA have reduced treatment response and retention rates to their first TNFi, highlighting the need to consider sex differences in PsA research and management., (© 2023 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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9. One-Third of European Patients With Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment.
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Ørnbjerg LM, Rugbjerg K, Georgiadis S, Rasmussen SH, Lindström U, Pavelka K, Yilmaz N, Favalli EG, Nissen MJ, Michelsen B, Vieira-Sousa E, Jones GT, Ionescu R, Relas H, Sanchez-Piedra C, Tomšič M, Geirsson AJ, van der Horst-Bruinsma I, Askling J, Loft AG, Nekvindova L, Direskeneli H, Iannone F, Ciurea A, Fagerli KM, Santos MJ, Macfarlane GJ, Codreanu C, Eklund K, Pombo-Suarez M, Rotar Z, Gudbjornsson B, Rusman T, Østergaard M, and Hetland ML
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- Humans, Tumor Necrosis Factor Inhibitors therapeutic use, Treatment Outcome, Pain, Fatigue drug therapy, Tumor Necrosis Factor-alpha, Spondylitis, Ankylosing drug therapy, Spondylarthritis drug therapy, Non-Radiographic Axial Spondyloarthritis
- Abstract
Objective: To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA)., Methods: Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, BASDAI, and BASFI; ≤ 0.5 for HAQ) were calculated at 6, 12, and 24 months of treatment., Results: Heterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, 6 months after the start of a first TNFi, pain score was reduced by approximately 60% (median at baseline/6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi., Conclusion: Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi., (Copyright © 2023 by the Journal of Rheumatology.)
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- 2023
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10. Discontinuation rate of sulfasalazine, leflunomide and methotrexate due to adverse events in a real-life setting (NOR-DMARD).
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Mielnik P, Sexton J, Fagerli KM, Bakland G, Hu Y, Kristianslund EK, Hoff M, Wierød A, and Kvien TK
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Objectives: MTX, LEF and SSZ are conventional synthetic DMARDs (csDMARDs) with a well-established role in the treatment of RA. We aimed to estimate and compare the relative risks for adverse events (AEs) and the discontinuation of these drugs owing to AEs., Methods: We included all 3339 patients from the NOR-DMARD study treated with MTX, LEF or SSZ in monotherapy. All reported AEs were compared between treatment groups using quasi-Poisson regression. In addition, drug retention rates were analysed using Kaplan-Meier estimates with Cox regression to control for possible confounders. We analysed drug retention rates and cumulative risk of discontinuation attributable to AEs using the Kaplan-Meier estimator. We assessed age, sex, baseline DAS in 28 joints with ESR (DAS28-ESR), seropositivity, prednisolone use, previous DMARD use, year of inclusion and co-morbidity as possible cofounders., Results: We found that the discontinuation rate attributable to AEs was significantly higher for LEF and SSZ than for MTX. After the first year, it was 13.7% (95% CI 12.2, 15.2), 39.6% (95% CI 34.8, 44) and 43.4% (95% CI 38.2, 48.1) for MTX, SSZ and LEF, respectively. Similar results were found when adjusting for confounders. The overall AEs were comparable across the treatment groups. The AE profile was as expected for each drug., Conclusion: Our work has shown a similar AE profile of csDMARDs to previous data. However, higher discontinuation rates for SSZ and LEF cannot be explained easily from AE profiles., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2023
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11. Treatment Response to Tumor Necrosis Factor Inhibitors and Methotrexate Monotherapy in Adults With Juvenile Idiopathic Arthritis: Data From NOR-DMARD.
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Bardan I, Fagerli KM, Sexton J, Kvien TK, Bakland G, Mielnik P, Hu Y, Lien G, Flatø B, Molberg Ø, Kristianslund EK, and Aga AB
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- Humans, Adult, Methotrexate therapeutic use, Tumor Necrosis Factor Inhibitors therapeutic use, Treatment Outcome, Tumor Necrosis Factor-alpha, Drug Therapy, Combination, Antirheumatic Agents adverse effects, Arthritis, Juvenile drug therapy, Arthritis, Juvenile chemically induced, Arthritis, Rheumatoid drug therapy
- Abstract
Objective: To compare the effectiveness of tumor necrosis factor inhibitors (TNFi) ± comedication and methotrexate (MTX) monotherapy between patients with adult juvenile idiopathic arthritis (JIA) and patients with rheumatoid arthritis (RA)., Methods: Adult patients with JIA and RA were identified from the Norwegian Antirheumatic Drug Register (NOR-DMARD) register. Disease activity measurements at baseline, 3, 6, and 12 months were compared between patients with JIA and RA starting (1) TNFi and (2) MTX monotherapy, using age- and gender-weighted analyses. We calculated differences between JIA and RA in mean changes in Disease Activity Score in 28 joints (DAS28), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI), among other disease activity measures. DAS28, CDAI, SDAI, and American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) remission rates at 3, 6, and 12 months, as well as 6- and 12-month Lund Efficacy Index (LUNDEX)-corrected rates, were calculated., Results: We identified 478 patients with JIA (TNFi/MTX monotherapy, n = 358/120) and 4637 patients with RA (TNFi/MTX monotherapy, n = 2292/2345). Patients with JIA had lower baseline disease activity compared to patients with RA across treatment groups. After baseline disease activity adjustment, there were no significant differences in disease activity change from baseline to 3, 6, and 12-months of follow-up between patients with JIA and RA for either treatment group. Twelve-month remission rates were similar between groups based on DAS28 (TNFi: JIA 55.2%, RA 49.5%; MTX monotherapy: JIA 45.3%, RA 41.2%) and ACR/EULAR remission criteria (TNFi: JIA 20.4%, RA 20%; MTX monotherapy: JIA 17%, RA 12.7%). Median drug survival (yrs) was similar for JIA and RA in both treatment groups (TNFi: JIA 1.2, RA 1.4; MTX monotherapy: JIA 1.3, RA 1.6)., Conclusion: TNFi and MTX monotherapy are effective in adult JIA, with similar effectiveness to that shown in RA., (Copyright © 2023 by the Journal of Rheumatology.)
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- 2023
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12. The impact of a csDMARD in combination with a TNF inhibitor on drug retention and clinical remission in axial spondyloarthritis.
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Nissen M, Delcoigne B, Di Giuseppe D, Jacobsson L, Hetland ML, Ciurea A, Nekvindova L, Iannone F, Akkoc N, Sokka-Isler T, Fagerli KM, Santos MJ, Codreanu C, Pombo-Suarez M, Rotar Z, Gudbjornsson B, van der Horst-Bruinsma I, Loft AG, Möller B, Mann H, Conti F, Yildirim Cetin G, Relas H, Michelsen B, Avila Ribeiro P, Ionescu R, Sanchez-Piedra C, Tomsic M, Geirsson ÁJ, Askling J, Glintborg B, and Lindström U
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- Humans, Tumor Necrosis Factor Inhibitors therapeutic use, Tumor Necrosis Factor-alpha, Treatment Outcome, Antirheumatic Agents therapeutic use, Spondylarthritis drug therapy, Axial Spondyloarthritis
- Abstract
Objectives: Many axial spondylarthritis (axSpA) patients receive a conventional synthetic DMARD (csDMARD) in combination with a TNF inhibitor (TNFi). However, the value of this co-therapy remains unclear. The objectives were to describe the characteristics of axSpA patients initiating a first TNFi as monotherapy compared with co-therapy with csDMARD, to compare one-year TNFi retention and remission rates, and to explore the impact of peripheral arthritis., Methods: Data was collected from 13 European registries. One-year outcomes included TNFi retention and hazard ratios (HR) for discontinuation with 95% CIs. Logistic regression was performed with adjusted odds ratios (OR) of achieving remission (Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP < 1.3 and/or BASDAI < 2) and stratified by treatment. Inter-registry heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Peripheral arthritis was defined as ≥1 swollen joint at baseline (=TNFi start)., Results: Amongst 24 171 axSpA patients, 32% received csDMARD co-therapy (range across countries: 13.5% to 71.2%). The co-therapy group had more baseline peripheral arthritis and higher CRP than the monotherapy group. One-year TNFi-retention rates (95% CI): 79% (78, 79%) for TNFi monotherapy vs 82% (81, 83%) with co-therapy (P < 0.001). Remission was obtained in 20% on monotherapy and 22% on co-therapy (P < 0.001); adjusted OR of 1.16 (1.07, 1.25). Remission rates at 12 months were similar in patients with/without peripheral arthritis., Conclusion: This large European study of axial SpA patients showed similar one-year treatment outcomes for TNFi monotherapy and csDMARD co-therapy, although considerable heterogeneity across countries limited the identification of certain subgroups (e.g. peripheral arthritis) that may benefit from co-therapy., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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13. Measuring quality of life of patients with axial spondyloarthritis for economic evaluation.
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Hernandez Alava M, Wailoo A, Chrysanthou G, Barcelos F, van Gaalen FA, Santos H, Fagerli KM, Gago L, Margarida Cunha M, van de Sande M, Couto MC, Bernardes M, Ramonda R, Exarchou S, Carvalho PD, van der Heijde D, and Machado PM
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- Cost-Benefit Analysis, Humans, Prospective Studies, Reproducibility of Results, Severity of Illness Index, Surveys and Questionnaires, Axial Spondyloarthritis, Quality of Life
- Abstract
Objectives: To estimate the relationship between EQ5D (three levels, UK version) and the Ankylosing Spondylitis Disease Activity Score (ASDAS) for use in the economic evaluation of health technologies for people with axial spondyloarthritis (axSpA). To compare against the relationship with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)., Methods: An electronic, prospective, Portuguese, nationwide, rheumatic disease register (Reuma.pt) provided data on 1140 patients (5483 observations) with a confirmed diagnosis of axSpA. We estimated models of EQ5D as a function of ASDAS, alone or in combination with measures of functional impairment, using bespoke mixture models which reflect the complex distributional features of EQ5D. The SPondyloArthritis Caught Early cohort provided data from 344 patients (1405 observations) in four European countries and was used for validation. A previously published model of BASDAI/Bath Ankylosing Spondylitis Functional Index (BASFI) was also used to generate predicted EQ5D scores and model performance compared., Results: A non-linear relationship exists between EQ5D from ASDAS. The final model included ASDAS, ASDAS squared, age and age squared and demonstrated close fit in both datasets except where data were sparse for patients with very high levels of disease activity (ASDAS >4). This finding held in the validation dataset. Models that included BASFI improved model fit. The ASDAS based models fit the data marginally less well than models using BASDAI., Conclusions: Mapping models linking ASDAS to EQ5D allow results from clinical studies to be used in economic evaluation of health technologies with confidence. There is some loss of information compared with BASDAI but this has only a marginal impact., Competing Interests: Competing interests: MvdS has received consulting fees/speaker’s fees/research grants from Novartis, UCB, Abbvie, Janssen, Eli Lilly and MSD. FAvG has received grants from Stichting vrienden van Sole Mio, Stichting ASAS, Jacobus Stichting, Novartis and UCB, and consulting fees from Novartis, Eli Lilly, MSD, AbbVie and Bristol Myers Squibb. MB has received consulting/speaker’s fees from AbbVie, Eli Lilly, Janssen and Novartis. RR has received consulting/speaker’s fees from AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB Pharma. SE has received consulting fees from AbbVie, Janssen and Novartis. DvdH has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma and serves as director of Imaging Rheumatology bv. PMM has received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB Pharma., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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14. Effectiveness and treatment retention of TNF inhibitors when used as monotherapy versus comedication with csDMARDs in 15 332 patients with psoriatic arthritis. Data from the EuroSpA collaboration.
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Lindström U, Di Giuseppe D, Delcoigne B, Glintborg B, Möller B, Ciurea A, Pombo-Suarez M, Sanchez-Piedra C, Eklund K, Relas H, Gudbjornsson B, Love TJ, Jones GT, Codreanu C, Ionescu R, Nekvindova L, Závada J, Atas N, Yolbas S, Fagerli KM, Michelsen B, Rotar Ž, Tomšič M, Iannone F, Santos MJ, Avila-Ribeiro P, Ørnbjerg LM, Østergaard M, Jacobsson LT, Askling J, and Nissen MJ
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- Adalimumab therapeutic use, Adult, Arthritis, Psoriatic physiopathology, Drug Therapy, Combination, Etanercept therapeutic use, Female, Humans, Infliximab therapeutic use, Male, Methotrexate therapeutic use, Middle Aged, Remission Induction, Treatment Outcome, Antirheumatic Agents therapeutic use, Arthritis, Psoriatic drug therapy, Tumor Necrosis Factor Inhibitors therapeutic use
- Abstract
Background: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during treatment with tumour necrosis factor inhibitors (TNFi) is extensively used in psoriatic arthritis (PsA), although the additive benefit remains unclear. We aimed to compare treatment outcomes in patients with PsA treated with TNFi and csDMARD comedication versus TNFi monotherapy., Methods: Patients with PsA from 13 European countries who initiated a first TNFi in 2006-2017 were included. Country-specific comparisons of 1 year TNFi retention were performed by csDMARD comedication status, together with HRs for TNFi discontinuation (comedication vs monotherapy), adjusted for age, sex, calendar year, disease duration and Disease Activity Score with 28 joints (DAS28). Adjusted ORs of clinical remission (based on DAS28) at 12 months were calculated. Between-country heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Secondary analyses stratified according to TNFi subtype (adalimumab/infliximab/etanercept) and restricted to methotrexate as comedication were performed., Results: In total, 15 332 patients were included (62% comedication, 38% monotherapy). TNFi retention varied across countries, with significant heterogeneity precluding a combined estimate. Comedication was associated with better remission rates, pooled OR 1.25 (1.12-1.41). Methotrexate comedication was associated with improved remission for adalimumab (OR 1.45 (1.23-1.72)) and infliximab (OR 1.55 (1.21-1.98)) and improved retention for infliximab. No effect of comedication was demonstrated for etanercept., Conclusion: This large observational study suggests that, as used in clinical practice, csDMARD and TNFi comedication are associated with improved remission rates, and specifically, comedication with methotrexate increases remission rates for both adalimumab and infliximab., Competing Interests: Competing interests: BeG reports grants from BMS, grants from Pfizer, grants from AbbVie, outside the submitted work. AC reports consultancy and speaker fees from Abbvie, Eli Lilly, Merck Sharp & Dohme, Novartis and Pfizer. MP-S reports speaker and research fees from Gilead, Janssen, MSD and Sanofi. KE reports consulting fees from Lilly, Biogene, Sobi, Pfizer and Gilead. HR reports personal fees from AbbVie, personal fees from Roche, personal fees from Pfizer, outside the submitted work. BjG reports other from Novartis, other from Amgen, outside the submitted work. GTJ reports grants from AbbVie, grants from Pfizer, grants from UCB, grants from Celgene / Amgen, grants from GSK, outside the submitted work. CC reports speaker fees and grants from AbbVie, Amgen, Egis, Novartis, Pfizer and UCB. RI reports speaker fee from Abbvie, Amgen, Novartis, Pfizer, Lilly and UCB. JZ reports speaker and consulting fees from Elli-Lilly, Abbvie, Novartis and UCB. SY reports speaker fees from Abbvie, MSD, Novartis, UCB, Sanofi and Pfizer. BM reports grants and personal fees from Novartis, outside the submitted work. ZR reports speaker fees, consultancy fees and support to biorx.si registry by, AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Medias, Medis, MSD, Novartis, OPH Oktal Pharma, Sandoz and Pfizer. MTreports speaker fees, consultancy fees and support to biorx.si registry by, AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Medias, Medis, MSD, Novartis, OPH Oktal Pharma, Sandoz and Pfizer. FI reports consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Lilly, Novartis, Sanofi, Celgene and UCB, outside this work. MJS reports personal fees from Abbvie, Novartis and Pfizer, outside the submitted work. PA-R reports research grant (paid to academic research institute) from Novartis. LMØ reports grants from Novartis, during the conduct of the study. MØ reports grants, personal fees and non-financial support from AbbVie, grants, personal fees and non-financial support from BMS, personal fees from Boehringer-Ingelheim, personal fees from Eli Lilly, personal fees and non-financial support from Janssen, grants, personal fees and non-financial support from Merck, personal fees and non-financial support from Pfizer, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from UCB, grants and personal fees from Celgene, personal fees from Sanofi, personal fees from Regeneron, grants, personal fees and non-financial support from Novartis, personal fees from Gilead, outside the submitted work. LJ reports lecture and consulting fees from Pfizer, Abbvie, Novartis, Eli-Lily and Janssen. JA reports grants from Abbvie, Astra-Zeneca, BMS, Eli Lilly, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB, outside the submitted work. MN reports research and consulting fees from Abbvie, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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15. Low specificity but high sensitivity of inflammatory back pain criteria in rheumatology settings in Europe: confirmation of findings from a German cohort study.
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de Hooge M, van Gaalen FA, Renson T, De Craemer AS, van de Sande MG, Ramonda R, Fagerli KM, Jacobsson LTH, van der Heijde D, Elewaut D, and Van den Bosch F
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- Adolescent, Adult, Back Pain etiology, Diagnosis, Differential, Europe, Female, Germany, Humans, Male, Middle Aged, Rheumatology methods, Sensitivity and Specificity, Spondylarthritis complications, Young Adult, Back Pain diagnosis, Rheumatology statistics & numerical data, Spondylarthritis diagnosis
- Abstract
Competing Interests: Competing interests: No, there are no competing interests for any author.
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- 2019
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16. Malignancy and mortality rates in patients with severe psoriatic arthritis requiring tumour-necrosis factor alpha inhibition: results from the British Society for Rheumatology Biologics Register.
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Fagerli KM, Kearsley-Fleet L, Mercer LK, Watson K, Packham J, Symmons DPM, and Hyrich KL
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- Adult, Aged, Arthritis, Psoriatic drug therapy, Cause of Death, Coronary Disease chemically induced, Coronary Disease mortality, Female, Humans, Incidence, Male, Middle Aged, Neoplasms chemically induced, Registries, Skin Neoplasms chemically induced, Skin Neoplasms mortality, United Kingdom epidemiology, Antirheumatic Agents adverse effects, Arthritis, Psoriatic mortality, Biological Products adverse effects, Neoplasms mortality, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objective: The aim of this study was to compare the incidence of cancer and all-cause and cause-specific mortality rates among a cohort of patients with severe PsA receiving TNF inhibitor (TNFi) with those of the general UK population., Methods: Cancers and deaths were identified from the national cancer and the national death registers in patients with PsA included in the British Society for Rheumatology Biologics Register from start of TNFi until 31 December 2012. Standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were calculated using published cancer and death rates for the general population. SIRs were calculated for both overall cancer risk and non-melanoma skin cancer. SMRs were calculated for (1) all-cause mortality, (2) death from malignancy and (3) death from circulatory disease. Gender-specific analyses were also performed., Results: Thirty-four cancers and 41 deaths among 709 patients were observed. The risk of malignancy overall was not increased (SIR 0.94; 95% CI: 0.65, 1.34). However, there was a significantly increased incidence of non-melanoma skin cancer (SIR 2.12; 95% CI: 1.19, 3.50). The all-cause mortality rate in our cohort was increased (SMR 1.56; CI: 1.12, 2.11). Death from malignancy was not increased, but death from coronary heart disease was increased (SMR 2.42; 95% CI: 1.11, 4.59)., Conclusion: In our cohort of patients with severe PsA, the overall incidence of malignancy was similar to that of the general population, although the incidence of non-melanoma skin cancer was increased. All-cause mortality was significantly increased, in part due to excess of deaths attributed to coronary heart disease.
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- 2019
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17. Frequency of Impaired Spinal Mobility in Patients with Chronic Back Pain Compared to Patients with Early Axial Spondyloarthritis.
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Fongen C, Dagfinrud H, Berg IJ, Ramiro S, van Gaalen F, Landewé R, Ramonda R, van der Heijde D, and Fagerli KM
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- Adult, Female, Humans, Male, Young Adult, Back Pain physiopathology, Chronic Pain physiopathology, Range of Motion, Articular physiology, Spine physiopathology, Spondylarthritis physiopathology
- Abstract
Objective: To examine the frequency of impaired spinal mobility in patients with chronic back pain of short duration and to compare it with the frequency of impaired spinal mobility in patients with axial spondyloarthritis (axSpA), possible SpA, and no SpA., Methods: The SpondyloArthritis Caught Early (SPACE) cohort includes patients with chronic back pain (≥ 3 mos, ≤ 2 yrs, onset < 45 yrs). Spinal mobility was assessed with lateral spinal flexion, chest expansion, cervical rotation, occiput-to-wall distance, and lumbar flexion. Hip mobility was assessed with intermalleolar distance. Mobility measures were defined as impaired if below the 5th percentile reference curve from general population, adjusted for age and height when appropriate. Proportions of patients categorized with impaired mobility were examined with chi square., Results: In total, 393 patients with chronic back pain were included: 142 axSpA, 140 possible SpA, and 111 no SpA. Impairment in ≥ 1 mobility measure was present in 66% of all patients. The most frequently impaired mobility measure was lateral spinal flexion (40%), followed by chest expansion (22%), cervical rotation (18%), intermalleolar distance (17%), lumbar flexion (15%), and occiput-to-wall distance (11%). No statistically significant differences in proportion of patients with impaired spinal mobility were found between patients with axSpA and the other subgroups in any of the tests., Conclusion: Two out of 3 patients with chronic back pain of short duration had impaired spinal mobility compared to the general population. Impaired spinal mobility occurs as often in patients with early axSpA as in other forms of chronic back pain.
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- 2018
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18. Imaging of the sacroiliac joints is important for diagnosing early axial spondyloarthritis but not all-decisive.
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Ez-Zaitouni Z, Landewé R, van Lunteren M, Bakker PA, Fagerli KM, Ramonda R, Jacobsson LTH, van der Heijde D, and van Gaalen FA
- Abstract
Objectives: To evaluate the contribution of the results of sacroiliac imaging to diagnosis and to the level of confidence in diagnosis in patients presenting with chronic back pain (CBP) and suspected of having axial spondyloarthritis (axSpA)., Methods: Data from 513 patients from the SPondyloArthritisCaughtEarly cohort with CBP (⩾3 months, ⩽2 years, onset <45 years) were analysed after full diagnostic work-up. Rheumatologists were asked not only to provide a diagnosis before and after the imaging results had been provided to them, but also to provide the level of confidence of this diagnosis on an 11-point numerical scale., Results: Before imaging, 317/513 patients were diagnosed with axSpA. Of these patients, 178/317 (56%) did not have signs of sacroiliitis on either MRI or radiography, which led to the rheumatologist refuting the initial diagnosis of axSpA in 81/178 (46%) patients. Of the 196/513 patients without axSpA before imaging, 35/196 (18%) had signs of sacroiliitis on imaging. Subsequently, 28/35 (80%) patients were diagnosed with axSpA. Overall, imaging was incongruent with the diagnosis before imaging in 213 patients. This led to a change in diagnosis in 109/213 (51%), which corresponds to 21% (109/513) of all patients in the cohort. In general, diagnostic confidence increased by having imaging results available (from 6.2 to 7.4, P < 0.001)., Conclusion: In patients with CBP suspected of having axSpA, sacroiliac imaging adds to the confidence in the final diagnosis. However, the number of changes in diagnosis suggests that imaging is important but not all-decisive in early axSpA diagnosis., (© The Author(s) 2018. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2018
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19. Impact of replacing radiographic sacroiliitis by magnetic resonance imaging structural lesions on the classification of patients with axial spondyloarthritis.
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Bakker PA, van den Berg R, Hooge M, van Lunteren M, Ez-Zaitouni Z, Fagerli KM, Landewé R, van Oosterhout M, Ramonda R, Reijnierse M, van Gaalen FA, and van der Heijde D
- Abstract
Objectives: To investigate in patients with chronic back pain of a short duration, the utility of adding structural MRI lesions of the SI joints to the imaging criterion of the Assessment of SpondyloArthritis International Society (ASAS) axial SpA (axSpA) criteria and the utility of replacement of radiographic sacroiliitis by structural MRI lesions., Methods: MRI STIR (inflammation, MRI-SI), MRI T1-weighted images (structural lesions, MRI-SI-s) and radiographs of the SI joints of patients in the SPondyloArthritis Caught Early-cohort (chronic back pain: ⩾3 months, ⩽2 years; onset <45 years) were scored by two well-calibrated readers. Previously proposed cut-offs for a positive MRI-SI-s were used (based on <5% prevalence in no-SpA patients): erosions ⩾3, fatty lesions ⩾3, fatty lesions and/or erosions (erosions/fatty lesions) ⩾5. Using the definitions of MRI-SI-s, patients were classified according to the ASAS axSpA criteria., Results: Twenty-nine of 294 patients were modified New York (mNY) positive and 32 were MRI-SI-s positive (erosions/fatty lesions ⩾5). Agreement between mNY and MRI-SI-s (erosions/fatty lesions ⩾5) was moderate (κ: 0.58). Using the erosions/fatty lesions ⩾5 cut-off, 3/294 additional patients were classified as axSpA (adding MRI). Using this cut-off instead of mNY (replacing mNY), classification did not change in 286 patients (97.3%), but 5 patients (1.7%) would not be classified as axSpA and 3 previously unclassified patients (1.0%) would be classified as axSpA. Similar results were seen for the other cut-offs (erosions ⩾3 and fatty lesions ⩾3)., Conclusion: Assessment of structural lesions (fatty lesions and erosions) on MRI-SI instead of or in addition to conventional radiographs does not lead to a different ASAS axSpA classification in most of the patients with early disease onset. This suggests that structural lesions (fatty lesions and erosions) can be reliably used in the ASAS axSpA classification of patients, as both addition and replacement of radiographs of the SI joints., (© The Author(s) 2018. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2018
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20. Long-term persistence of TNF-inhibitor treatment in patients with psoriatic arthritis. Data from the British Society for Rheumatology Biologics Register.
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Fagerli KM, Kearsley-Fleet L, Watson KD, Packham J, Contributors Group BR, Symmons DPM, and Hyrich KL
- Abstract
Background: Long-term effectiveness of tumour necrosis factor alpha inhibitors (TNFi) has mainly been explored in patients with rheumatoid arthritis (RA) and the data available on patients with psoriatic arthritis (PsA) includes limited follow-up., Objective: Investigate long-term effectiveness of first TNFi in a PsA population by describing treatment persistence, identify factors associated with 5-year persistence and further investigate comparative long-term effectiveness of subsequent TNFi treatments through persistence to treatment., Methods: Patients with a rheumatologist diagnosis of PsA receiving their first TNFi registered in the British Society for Rheumatology Biologics Register (BSRBR) (2002-2006) were included. Treatment at different time points was described and factors associated with 5-year treatment persistence were identified by logistic regression. Kaplan-Meier analysis was used to assess factors associated with persistence to first TNFi and subsequent TNFi treatments., Results: At 5 years, 46.7% of patients were still on their initial TNFi treatment. Better 5 -year persistence was associated with male gender, use of etanercept or adalimumab rather than infliximab and absence of baseline comorbidity. Five-year persistence estimates (95% CI) of first, second and third TNFi were 53% (49% to 57%), 60% (43% to 57%) and 48% (36% to 59%), respectively., Conclusion: We found good long-term persistence of TNFi in this PsA population both for the first and subsequent TNFi treatments. The relationship between persistence and relevant clinical factors was not strong and demonstrates the difficulties in predicting outcome of TNFi treatment in PsA., Competing Interests: Competing interests: KLH received research grants from AbbVie and Pfizer.
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- 2018
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21. The influence of discrepant imaging judgements on the classification of axial spondyloarthritis is limited: a replication in the SpondyloArthritis Caught Early (SPACE) cohort.
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Ez-Zaitouni Z, van Lunteren M, Bakker PAC, van den Berg R, Reijnierse M, Fagerli KM, Landewé RBM, Ramonda R, Jacobsson LTH, van Gaalen FA, and van der Heijde D
- Subjects
- Back Pain diagnostic imaging, Chronic Pain diagnostic imaging, Cohort Studies, Humans, Magnetic Resonance Imaging methods, Observer Variation, Sacroiliitis diagnostic imaging, Sacroiliac Joint diagnostic imaging, Spondylarthritis diagnostic imaging
- Abstract
Competing Interests: Competing interests: None declared.
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- 2018
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22. Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study.
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Michelsen B, Kristianslund EK, Sexton J, Hammer HB, Fagerli KM, Lie E, Wierød A, Kalstad S, Rødevand E, Krøll F, Haugeberg G, and Kvien TK
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- Adult, Aged, Arthralgia drug therapy, Arthralgia etiology, Arthralgia psychology, Arthritis, Psoriatic complications, Arthritis, Psoriatic drug therapy, Arthritis, Rheumatoid complications, Arthritis, Rheumatoid drug therapy, Female, Follow-Up Studies, Humans, Logistic Models, Male, Methotrexate therapeutic use, Middle Aged, Predictive Value of Tests, Prospective Studies, Remission Induction, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Antirheumatic Agents therapeutic use, Anxiety psychology, Arthritis, Psoriatic psychology, Arthritis, Rheumatoid psychology, Depression psychology
- Abstract
Objective: To investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up., Methods: We included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models., Results: Baseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score <2.6, Simplified Disease Activity Index ≤3.3, Clinical Disease Activity Index ≤2.8, ACR/EULAR Boolean and Disease Activity Index for Psoriatic Arthritis ≤4 remission after 3 and 6 months treatment in RA (p≤0.008) and partly in PsA (p from 0.001 to 0.73). Baseline depression/anxiety was associated with increased patient's and evaluator's global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants., Conclusion: Depression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target., Competing Interests: Competing interests: HBH has received fees for speaking and/or consulting from AbbVie, Pfizer, UCB, Roche, MSD, BMS and Novartis. TKK has received fees for speaking and/or consulting from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB and received research funding to Diakonhjemmet Hospital from AbbVie, BMS, MSD, Pfizer, Roche and UCB. All other authors have declared that no competing interests exist., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
- Published
- 2017
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23. The yield of a positive MRI of the spine as imaging criterion in the ASAS classification criteria for axial spondyloarthritis: results from the SPACE and DESIR cohorts.
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Ez-Zaitouni Z, Bakker PA, van Lunteren M, de Hooge M, van den Berg R, Reijnierse M, Fagerli KM, Landewé RB, Ramonda R, Jacobsson LT, Saraux A, Lenczner G, Feydy A, Pialat JB, Thévenin F, van Gaalen FA, and van der Heijde D
- Subjects
- Adult, Back Pain diagnostic imaging, Back Pain etiology, Chronic Pain diagnostic imaging, Chronic Pain etiology, Cohort Studies, Female, Humans, Male, Observer Variation, Radiography, Spondylarthropathies complications, Young Adult, Magnetic Resonance Imaging, Sacroiliac Joint diagnostic imaging, Sacroiliitis diagnostic imaging, Spine diagnostic imaging, Spondylarthropathies diagnostic imaging
- Abstract
Objectives: To assess the prevalence of spinal inflammation on MRI in patients with chronic back pain (CBP) of maximally 3 years duration and to evaluate the yield of adding a positive MRI-spine as imaging criterion to the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis (axSpA)., Methods: Baseline imaging of the sacroiliac joints (X-SI), MRI of the sacroiliac joints (MRI-SI) and MRI-spine were scored by ≥2 experienced central readers per modality in the SPondyloArthritis Caught Early (SPACE) and DEvenir des Spondylarthropathies Indifférenciées Récentes (DESIR) cohorts. Inflammation suggestive of axSpA was assessed in the entire spine. A positive MRI-spine was defined by the presence of ≥5 inflammatory lesions. Alternative less strict definitions were also tested., Results: In this study, 541 and 650 patients with CBP from the SPACE and DESIR cohorts were included. Sacroiliitis on X-SI and MRI-SI was found in 40/541 (7%) and 76/541 (14%) patients in SPACE, and in DESIR in 134/650 (21%) and 231/650 (36%) patients, respectively. In SPACE and DESIR, a positive MRI-spine was seen in 4/541 (1%) and 48/650 (7%) patients. Of the patients without sacroiliitis on imaging, 3/447 (1%) (SPACE) and 8/382 (2%) (DESIR) patients had a positive MRI-spine. Adding positive MRI-spine as imaging criterion led to new classification in only one patient in each cohort, as the other patients already fulfilled the clinical arm. Other definitions of a positive MRI-spine yielded similar results., Conclusion: In two cohorts of patients with CBP with a maximum symptom duration of 3 years, a positive MRI-spine was rare in patients without sacroiliitis on MRI-SI and X-SI. Addition of MRI-spine as imaging criterion to the ASAS axSpA criteria had a low yield of newly classified patients and is therefore not recommended., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
- Published
- 2017
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24. Discordance between tender and swollen joint count as well as patient's and evaluator's global assessment may reduce likelihood of remission in patients with rheumatoid arthritis and psoriatic arthritis: data from the prospective multicentre NOR-DMARD study.
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Michelsen B, Kristianslund EK, Hammer HB, Fagerli KM, Lie E, Wierød A, Kalstad S, Rødevand E, Krøll F, Haugeberg G, and Kvien TK
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- Adult, Aged, Arthritis, Psoriatic complications, Arthritis, Rheumatoid complications, Disability Evaluation, Female, Humans, Longitudinal Studies, Male, Methotrexate therapeutic use, Middle Aged, Norway, Predictive Value of Tests, Prospective Studies, Registries, Remission Induction, Severity of Illness Index, Surveys and Questionnaires, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Antirheumatic Agents therapeutic use, Arthralgia etiology, Arthritis, Psoriatic drug therapy, Arthritis, Rheumatoid drug therapy, Diagnostic Self Evaluation, Edema etiology
- Abstract
Objective: To investigate the predictive value of discordance between (1) tender and swollen joint count and (2) patient's and evaluator's global assessment on remission in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA)., Methods: From the prospective, multicentre Norwegian-Disease-Modifying Antirheumatic Drug study, we included patients with RA and PsA starting first-time tumour necrosis factor inhibitors and DMARD-naïve patients starting methotrexate between 2000 and 2012. The predictive value of ΔTSJ (tender minus swollen joint counts) and ΔPEG (patient's minus evaluator's global assessment) on remission was explored in prespecified logistic regression models adjusted for age, sex, disease duration and smoking., Results: A total of 2735 patients with RA and 1236 patients with PsA were included (mean (SD) age 55.0 (13.5)/48.3 (12.4) years, median(range) disease duration 0.7 (0.0-58.0)/1.3 (0.0-48.3) years, 69.7/48.4% females). Baseline ΔTSJ/ΔPEG reduced the likelihood of achieving DAS28<2.6, SDAI≤3.3, CDAI≤2.8, ACR/EULAR Boolean and DAPSA<4 remission after 3 and 6 months in RA (OR 0.95-0.97, p<0.001/OR 0.96-0.99, p≤0.01) and PsA (OR 0.91-0.94, p≤0.004/OR 0.89-0.99, p≤0.002), except for ΔPEG and 6-month DAS28 remission in PsA., Conclusions: Discordance between patient's and physician's evaluation of disease activity reflected through ΔTSJ and partly ΔPEG may reduce likelihood of remission in RA and PsA. The findings are relevant for use of the treat-to-target strategy in individual patients., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)
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- 2017
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25. Are Additional Tests Needed to Rule Out Axial Spondyloarthritis in Patients Ages 16-45 Years With Short-Duration Chronic Back Pain and Maximally One Spondyloarthritis Feature?
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Bakker PA, Ez-Zaitouni Z, van Lunteren M, van den Berg R, De Hooge M, Fagerli KM, Landewé R, van Oosterhout M, Ramonda R, Reijnierse M, van der Heijde D, and van Gaalen FA
- Subjects
- Adolescent, Adult, Axis, Cervical Vertebra pathology, Diagnosis, Differential, Europe, Female, HLA-B27 Antigen blood, Humans, Magnetic Resonance Imaging methods, Male, Middle Aged, Physical Examination, Radiography, Sacroiliac Joint diagnostic imaging, Time Factors, Young Adult, Back Pain diagnosis, Chronic Pain diagnosis, Spondylarthritis diagnosis
- Abstract
Objective: To investigate whether HLA-B27 testing and imaging of the sacroiliac joints are needed in patients with ≤1 spondyloarthritis (SpA) feature, referred to a secondary care setting, after medical history collection, clinical examination, and measurement of acute phase reactants., Methods: Baseline data from patients in the Spondyloarthritis Caught Early (SPACE) cohort visiting the rheumatology outpatient clinic of 5 centers across Europe (with back pain ≥3 months, ≤2 years, onset at ages <45 years) were used. All patients underwent a full diagnostic work-up: magnetic resonance imaging (MRI) and radiographs of the sacroiliac joints, HLA-B27 testing, and assessment of all other SpA features. Patients were diagnosed according to the treating rheumatologist and classified according to the Assessment of SpondyloArthritis international Society (ASAS) axial SpA criteria., Results: Of the 354 patients, 133 (37.5%) showed 0 or 1 SpA feature after medical history collection, physical examination, and measurement of acute phase reactants (38 without SpA features, 95 with 1 SpA feature). Of the patients with ≤1 SpA feature, 18.4% (with 0 SpA features) and 17.9% (with 1 SpA feature) were diagnosed with axial SpA according to the rheumatologist after additional investigations (HLA-B27 testing and sacroiliac joint imaging). Additionally, 4 of 38 patients (10.5%) without SpA features fulfilled the ASAS axial SpA criteria (all according to the imaging arm only: 2 as MRI+/modified New York criteria (mNY)+, 1 as MRI+/mNY-, and 1 as MRI-/mNY+). Of the 95 patients with 1 SpA feature, 22 (23.2%) fulfilled the ASAS axial SpA criteria (all according to the imaging arm only: 3 as MRI+/mNY+, 15 as MRI+/mNY-, and 4 as MRI-/mNY+)., Conclusion: In these patients in a secondary care setting with ≤1 SpA feature, axial SpA could not be ruled out without sacroiliac joint imaging and/or HLA-B27 testing., (© 2016, American College of Rheumatology.)
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- 2016
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26. Signal intensity loss of the intervertebral discs in the cervical spine of young patients on fluid sensitive sequences.
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de Bruin F, Ter Horst S, van den Berg R, de Hooge M, van Gaalen F, Fagerli KM, Landewé R, van Oosterhout M, Bloem JL, van der Heijde D, and Reijnierse M
- Subjects
- Adolescent, Adult, Axis, Cervical Vertebra diagnostic imaging, Axis, Cervical Vertebra pathology, Cerebrospinal Fluid cytology, Cerebrospinal Fluid diagnostic imaging, Female, Humans, Image Enhancement methods, Image Interpretation, Computer-Assisted methods, Male, Middle Aged, Observer Variation, Reproducibility of Results, Sensitivity and Specificity, Signal-To-Noise Ratio, Young Adult, Aging pathology, Intervertebral Disc diagnostic imaging, Intervertebral Disc pathology, Intervertebral Disc Degeneration diagnostic imaging, Intervertebral Disc Degeneration pathology, Magnetic Resonance Imaging methods
- Abstract
Objective: To evaluate the signal intensity (SI) of the intervertebral discs of the cervical spine on magnetic resonance (MR) fluid sensitive sequences, and correlate this to secondary signs of degeneration on MR and radiographs as well as to age., Material and Methods: A total of 265 patients aged ≥16 with back pain (≥3-months, <2-year, onset <45-years) from the SPondyloArthritis Caught Early (SPACE) cohort were included. Sagittal 1.5 T MR images and lateral radiographs of the cervical spine were independently evaluated by two readers for: SI of the intervertebral discs using a grading system based of Pfirrmann (grade 1 normal/bright SI; 2 inhomogeneous/bright SI; 3 inhomogeneous/mildly decreased SI; 4 inhomogeneous/markedly decreased SI; 5 signal void), disc herniation and Modic changes (MRI) and disc space narrowing, osteophytes and sclerosis (radiograph). Readers were blinded for clinical information. Descriptive statistics were used for characteristics and prevalence of findings, and regression analysis was used for age and grades., Results: Of 265 patients (36% male, mean age 30), 221 (83%) patients had 1 to 6 discs (median 4) with decreased SI. Of 1,590 discs, 737 (46%) were grade 1; 711 (45%) grade 2; 133 (8%) grade 3; 8 (1%) grade 4 and 1 (0%) grade 5. Secondary signs of degeneration were rare and seen predominantly in C5-C7 and appear to be related to signal loss grade 3 and 4., Conclusion: Low signal intensity of intervertebral discs in absence of secondary degenerative signs in the cervical spine on fluid sensitive MR images might be pre-existing and part of the natural course.
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- 2016
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27. Prevalence of degenerative changes of the spine on magnetic resonance images and radiographs in patients aged 16-45 years with chronic back pain of short duration in the Spondyloarthritis Caught Early (SPACE) cohort.
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de Bruin F, ter Horst S, Bloem HL, van den Berg R, de Hooge M, van Gaalen F, Fagerli KM, Landewé R, van Oosterhout M, van der Heijde D, and Reijnierse M
- Subjects
- Adolescent, Adult, Back Pain diagnosis, Back Pain etiology, Cervical Vertebrae diagnostic imaging, Cervical Vertebrae pathology, Chronic Pain diagnosis, Chronic Pain etiology, Female, Follow-Up Studies, Humans, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae pathology, Male, Middle Aged, Netherlands epidemiology, Prevalence, Radiography, Spondylarthritis diagnosis, Time Factors, Young Adult, Back Pain epidemiology, Chronic Pain epidemiology, Early Diagnosis, Magnetic Resonance Imaging methods, Spondylarthritis complications
- Abstract
Objectives: To determine the prevalence of degenerative changes (DCs) in the spine of young patients with back pain without axial spondyloarthritis (no-axSpA), with possible axSpA (poss-axSpA) and with definite axSpA (axSpA), as shown on MRI and radiographs., Methods: Whole-spine MRI and cervical and lumbar radiography were performed in patients ≥16 years of age with chronic back pain (≥3 months, ≤2 years, onset <45 years) and potential axSpA (Spondyloarthritis Caught Early cohort). Patients were classified as no-axSpA, poss-axSpA [not fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria] or axSpA (fulfilling ASAS axSpA criteria). Images (MRI and X-rays) were evaluated on the presence of DCs by two independent readers, blinded to clinical and laboratory information as well as to the results of the other imaging modality. In cases of disagreement, a third reader served as adjudicator. A Chi-square test was used to analyse differences between patient groups according to various selected cut-off points (1-3) of individual DCs., Results: Of 274 patients (38% male, mean age: 29 years), 25 (9%) were classified as no-axSpA, 134 (48.9%) as poss-axSpA and 115 (42.0%) as axSpA. Two hundred and forty-five (89%) patients had DCs on MRI [21/25 (84%) no-axSpA, 121/134 (90%) poss-axSpA, 103/115 (90%) axSpA, P = 0.792], range 1-29 (median 5.5), and 121 (44%) patients had DCs on radiographs [13/25 (52%) no-axSpA, 62/134 (46%) poss-axSpA, 48/115 (42%) axSpA, P = 0.261], range 1-11 (median 2). Prevalence of DCs was similar between patient groups. DCs were predominantly found in the lumbar spine., Conclusion: Prevalence of DCs was high in this cohort of young patients with short-term chronic back pain, in accordance with the literature. Prevalence of DCs in no-axSpA patients, poss-axSpA patients and axSpA patients was found to be similar., (© The Author 2015. 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
- 2016
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28. Metric Properties of the SPARCC Score of the Sacroiliac Joints - Data from Baseline, 3-month, and 12-month Followup in the SPACE Cohort.
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van den Berg R, de Hooge M, Bakker PA, van Gaalen F, Navarro-Compán V, Fagerli KM, Landewé R, van Oosterhout M, Ramonda R, Reijnierse M, and van der Heijde D
- Subjects
- Adult, Female, Humans, Magnetic Resonance Imaging, Male, Young Adult, Back Pain pathology, Sacroiliac Joint pathology, Spondylarthritis pathology
- Abstract
Objective: To evaluate metric properties of the SpondyloArthritis Research Consortium of Canada (SPARCC) score of the sacroiliac (SI) joints., Methods: Patients with back pain (≥ 3 months, ≤ 2 years, onset < 45 years) were included in the SPACE cohort (SpondyloArthritis Caught Early). Patients with (possible) axial spondyloarthritis had followup visits after 3 and 12 months and were treated according to clinical practice. Magnetic resonance imaging (MRI) of the SI joints (MRI-SI) was scored in 2 independent campaigns (campaign 1: at baseline and 3 months; campaign 2: at baseline, 3 months, and 12 months) by 2 different blinded reader pairs, applying the Assessment of Spondyloarthritis International Society (ASAS) definition (MRI-SI+ vs MRI-SI-; discordant cases were adjudicated by a third reader) and SPARCC score (mean of 2 agreeing readers). Calculations were made for agreement between SPARCC score cutoff values and a consensus judgment of MRI-SI+ (ASAS definition) as external standard, change in SPARCC score, and smallest detectable changes (SDC) over 3 and 12 months., Results: SPARCC score ≥ 2 showed best agreement with MRI-SI+ in both campaigns. Regarding observed changes in relation to SDC, SPARCC score changed in 70/151 patients; 26/70 patients changed > SDC (3.4), of whom 20 patients received stable treatment over 3 months in campaign 1. Over 3 months, 20/68 patients showed changes in SPARCC score; 11/20 > SDC (2.1), of whom 8 patients received stable treatment. Over 1 year, 23/74 patients changed their SPARCC score; 14/23 changed > SDC (2.4), of whom 7 received stable treatment in campaign 2., Conclusion: SPARCC score ≥ 2 can be used as surrogate for a consensus judgment of MRI-SI+ (ASAS definition) in clinical trials. The SDC ranged from 2.1-3.4 dependent on reader pair and were close to the proposed minimum important change of 2.5.
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- 2015
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29. First-time prescriptions of biological disease-modifying antirheumatic drugs in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis 2002-2011: data from the NOR-DMARD register.
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Lie E, Fagerli KM, Mikkelsen K, Rødevand E, Lexberg A, Kalstad S, Uhlig T, and Kvien TK
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- Arthritis, Psoriatic drug therapy, Arthritis, Rheumatoid drug therapy, Drug Utilization trends, Humans, Norway, Registries, Spondylarthritis drug therapy, Antirheumatic Agents therapeutic use, Arthritis drug therapy, Biological Products therapeutic use, Drug Prescriptions statistics & numerical data
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- 2014
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30. Is there a role for sulphasalazine in axial spondyloarthritis in the era of TNF inhibition? Data from the NOR-DMARD longitudinal observational study.
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Fagerli KM, van der Heijde D, Heiberg MS, Wierød A, Kalstad S, Rødevand E, Mikkelsen K, Kvien TK, and Lie E
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- Adult, Biological Products therapeutic use, Drug Substitution, Female, Humans, Kaplan-Meier Estimate, Longitudinal Studies, Male, Middle Aged, Severity of Illness Index, Treatment Failure, Treatment Outcome, Antirheumatic Agents therapeutic use, Spondylarthritis drug therapy, Sulfasalazine therapeutic use, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objectives: The objectives of this study were to characterize patients with predominantly axial SpA who received SSZ as their first DMARD, compare the response to treatment in patients with and without peripheral disease and identify predictors of discontinuation of SSZ. We also investigated response to TNF inhibitor (TNFi) after SSZ failure., Methods: We included DMARD-naive patients with predominantly axial SpA starting SSZ or TNFi treatment from a Norwegian, multicentre longitudinal observational study (NOR-DMARD). In patients starting SSZ, we compared the 3-month responses between patients with and without swollen joints and identified predictors of discontinuation by Cox regression analysis. Sixty-six SSZ-treated patients later switched to a TNFi, and we compared their 3-month responses and drug survival to patients starting a TNFi as their first DMARD., Results: Patients receiving SSZ (n = 181) as their first DMARD had shorter disease duration, were more frequently female and had more swollen joints than those starting TNFi (n = 543). There was a trend toward better 3-month responses to SSZ in patients with peripheral joint swelling, and they had significantly better 3-year drug survival than patients without swollen joints at baseline. Predictors of SSZ discontinuation were no peripheral joint swelling, higher CRP and higher BASDAI back pain score. TNFi response was similar in patients previously treated with SSZ, as in DMARD-naive patients., Conclusion: Our findings support current recommendations of SSZ as an optional treatment in SpA patients with peripheral disease, although overall responses were modest. Initial treatment with SSZ does not seem to impair later TNFi response.
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- 2014
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31. The role of methotrexate co-medication in TNF-inhibitor treatment in patients with psoriatic arthritis: results from 440 patients included in the NOR-DMARD study.
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Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Lexberg AS, Rødevand E, Kalstad S, Mikkelsen K, and Kvien TK
- Subjects
- Adalimumab, Adult, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized pharmacokinetics, Antirheumatic Agents adverse effects, Antirheumatic Agents pharmacokinetics, Drug Therapy, Combination, Etanercept, Female, Humans, Immunoglobulin G adverse effects, Immunoglobulin G metabolism, Infliximab, Longitudinal Studies, Male, Methotrexate adverse effects, Methotrexate pharmacokinetics, Middle Aged, Receptors, Tumor Necrosis Factor metabolism, Treatment Outcome, Antirheumatic Agents administration & dosage, Arthritis, Psoriatic drug therapy, Immunoglobulin G administration & dosage, Methotrexate administration & dosage, Receptors, Tumor Necrosis Factor administration & dosage, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Background: The role of co-medication with tumour necrosis factor inhibitors (TNFi) is well established in rheumatoid arthritis and ankylosing spondylitis. In psoriatic arthritis (PsA) there is little evidence available on this issue., Material and Methods: The analyses were based on data from the Norwegian longitudinal observational study on disease-modifying antirheumatic drugs (NOR-DMARD). Patients with PsA starting their first TNFi, either as monotherapy or with concomitant methotrexate (MTX), were selected. Baseline characteristics, responses after 3, 6 and 12 months, and drug survival were compared between those with and without MTX co-medication. A secondary analysis was performed on patients who had confirmed swollen joints at baseline. Cox regression was used to identify predictors of discontinuation., Results: We included 440 patients, 170 receiving TNFi as monotherapy and 270 receiving concomitant MTX. The groups had similar baseline characteristics, except for number of swollen joints, which was higher in the concomitant MTX group. Responses were similar in the two groups in both analyses. Drug survival analyses revealed a borderline significant difference in favour of patients receiving co-medication (p=0.07), and this was most prominent for patients receiving infliximab (IFX) (p=0.01). In the Cox regression analysis lack of concomitant MTX and current smoking were independent predictors of discontinuation of TNFi., Conclusions: We found similar responses to TNFi in patients with and without concomitant MTX, but drug survival was superior in patients receiving co-medication. The effect of MTX on drug survival was most prominent in patients receiving IFX. Smoking at baseline and use of TNFi as monotherapy were identified as independent predictors of drug discontinuation.
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- 2014
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32. Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study.
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Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Kalstad S, Rødevand E, Mikkelsen K, Lexberg AS, and Kvien TK
- Subjects
- Adalimumab, Adult, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Certolizumab Pegol, Etanercept, Female, Humans, Immunoglobulin Fab Fragments therapeutic use, Immunoglobulin G therapeutic use, Infliximab, Longitudinal Studies, Male, Middle Aged, Polyethylene Glycols therapeutic use, Receptors, Tumor Necrosis Factor therapeutic use, Remission Induction methods, Treatment Outcome, Antirheumatic Agents therapeutic use, Arthritis, Psoriatic drug therapy, Drug Substitution, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Background: Tumour necrosis factor inhibitors (TNFi) are efficacious in patients with psoriatic arthritis (PsA), but some patients do not respond or do not tolerate their first TNFi, and are switched to a different TNFi. Evidence supporting this practice is limited, and we wanted to investigate the effectiveness of switching to a second TNFi., Material and Methods: From a longitudinal observational study (LOS) we selected patients with PsA who were starting their first TNFi, and identified patients who had switched to a second TNFi ('switchers'). Three-month responses and 3-year drug-survival were compared between switchers and non-switchers, and within switchers., Results: Switchers (n=95) receiving their second TNFi had significantly poorer responses compared with non-switchers (n=344) (ACR50 response: 22.5% vs 40.0%, DAS28 remission: 28.2% vs 54.1%). There was a trend towards poorer responses to the second TNFi compared with the first TNFi within switchers. Estimated 3-year drug-survival was 36% for the second TNFi compared with 57% for the first TNFi overall., Conclusions: 20-40% of patients had a response on a second TNFi after having failed one TNFi in this LOS. This observation highlights the need for treatments with other mechanisms of action than TNF inhibition in patients with PsA.
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- 2013
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33. Selecting patients with ankylosing spondylitis for TNF inhibitor therapy: comparison of ASDAS and BASDAI eligibility criteria.
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Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Kaufmann C, Rødevand E, Mikkelsen K, Kalstad S, and Kvien TK
- Subjects
- Adult, C-Reactive Protein metabolism, Female, Humans, Longitudinal Studies, Male, Middle Aged, Spondylitis, Ankylosing metabolism, Surveys and Questionnaires, Antirheumatic Agents therapeutic use, Patient Selection, Severity of Illness Index, Spondylitis, Ankylosing drug therapy, Spondylitis, Ankylosing physiopathology, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objective: To compare Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1 with BASDAI >4 as an eligibility criterion for initiation of TNF inhibitor (TNFi) treatment in AS, and to investigate if ASDAS performs satisfactorily in patients without elevated CRP or without peripheral joint swelling., Methods: Two hundred and eighty-nine patients starting their first TNFi were identified from a longitudinal observational study (NOR-DMARD) and grouped according to the fulfilment of ASDAS and BASDAI TNFi eligibility criteria. The 3-month responses were compared across several response measures. Patients were also grouped according to CRP level and the presence or absence of swollen joints, and responses were compared., Results: The majority of patients (n = 212) fulfilled both eligibility criteria, and this group had the best response. Very few patients (n = 4) fulfilled only the BASDAI criterion. Patients fulfilling only the ASDAS criterion (n = 48) had a reasonable response. Patients with an elevated vs not elevated CRP at baseline had better responses according to all response measures, but patients without elevated CRP also responded. We also observed trends towards better responses in patients with vs without peripheral joint swelling., Conclusion: More patients were eligible for TNFi using the ASDAS than the BASDAI eligibility criterion (n = 260 vs n = 216). Fulfilment of both criteria gave the greatest likelihood of improvement, but the patients who only fulfilled the ASDAS criterion also improved. ASDAS was found to be applicable also in subgroups without elevated CRP and without peripheral joint swelling.
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- 2012
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