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Objective To investigate the longitudinal association between radiographic sacroiliitis progression and treatment with tumor necrosis factor inhibitors (TNFi) in patients with early axial spondyloarthritis (SpA) in a long-term inception cohort. Methods We included patients from the German Spondyloarthritis Inception Cohort who underwent radiographic assessment of the sacroiliac joints at baseline and at least once more during the 10-year follow-up. Two central readers scored the radiographs according to the modified New York criteria for ankylosing spondylitis. The sacroiliac sum score was calculated as a mean of the scores determined by both readers. TNFi use was assessed according to exposure in the current and/or previous 2-year radiographic interval. The association between TNFi use and radiographic sacroiliitis progression was examined by longitudinal generalized estimating equation analysis with adjustment for potential confounders. Results In this long-term inception cohort, 10-year follow-up data on 737 radiographic intervals assessed in 301 patients with axial SpA (166 patients with nonradiographic axial SpA and 135 patients with radiographic axial SpA) were obtained. Having received >= 12 months of treatment with TNFi in the previous 2-year radiographic interval was associated with a significant decrease in the sacroiliitis sum score (beta = -0.09 [95% confidence interval (95% CI) -0.18, -0.003]; analyses adjusted for age, sex, symptom duration, HLA-B27 status, Bath Ankylosing Spondylitis Disease Activity Index score, C-reactive protein, and nonsteroidal antiinflammatory drug intake). In contrast, among patients receiving TNFi in the current radiographic interval, there was no significant association with change in the sacroiliitis sum score (beta = 0.05 [95% CI -0.05, 0.14]). This effect of having received >= 12 months of treatment with TNFi in the previous 2-year radiographic interval was stronger in patients with nonradiographic axial SpA as compared to patients with radiographic axial SpA (beta = -0.16 [95% CI -0.28, -0.03] versus beta = -0.04 [95% CI -0.15, 0.07]). Conclusion Treatment with TNFi was associated with the reduction in radiographic sacroiliitis progression in patients with axial SpA. This effect became evident between 2 and 4 years after treatment was initiated.

BackgroundPatients (pts) with axial spondyloarthritis (axSpA) are classified into radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA) based on the presence or absence of radiographic sacroiliitis. Approximately 20% to 80% of newly diagnosed axSpA pts have nr-axSpA and 8% to 40% progress to r-axSpA over the next 2 to 10 years.ObjectivesTo evaluate progression from nr-axSpA to r-axSpA over 5 years in a prospective multicentre cohort.MethodsPROOF was a global, real-world, prospective, observational study conducted in rheumatology clinical practices in 29 countries across 6 different geographic regions.1 The study enrolled adults with chronic back pain for ≥3 months and onset before 45 years of age. This analysis included pts diagnosed with axSpA who also fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA. Study visits occurred at baseline (BL) and yearly thereafter. Baseline and follow-up radiographs of sacroiliac joints (SIJ) were evaluated for pts with initial nr-axSpA diagnosis independently by 2 central readers according to the modified New York criteria. In the case of disagreement on the classification (nr- or r-axSpA), images were adjudicated by a third reader. Radiographic progression from nr-axSpA to r-axSpA over 5 years was evaluated by Kaplan-Meier analysis. Cox proportional hazards regression analyses for time to radiographic progression from nr-axSpA to r-axSpA were conducted. For model 1, ‘imaging arm vs clinical arm’ was used as an independent variable, and for model 2, ‘active inflammation on magnetic resonance imaging highly suggestive of sacroiliitis associated with SpA’ was used. Further, potential predictive factors included in the models were age, gender, back pain duration, number of SpA parameters, smoking status, CRP, good response to NSAIDs, HLA-B27 status, and current use of NSAIDs and TNF inhibitors.ResultsAmong 2633 enrolled pts, 2165 (82%) were diagnosed with axSpA and fulfilled the ASAS classification criteria. Among these, 1612 (74%) were classified as having r-axSpA (1050 [65%]) or nr-axSpA (562 [35%]) by central reading. The majority of nr-axSpA pts (77%) fulfilled the ASAS classification criteria due to positive findings on imaging (plus ≥1 SpA feature) and 23% were classified according to the clinical arm. A total of 246 nr-axSpA pts who had ≥1 follow-up SIJ radiograph were included in this analysis. Among these 246 pts, progression from initial nr-axSpA to r-axSpA at any of the follow-up visits was observed in 40 pts (16%) over 5 years. Mean time to radiographic progression was 2.4 years (ranging from 0.9 to 5.1 years) in descriptive analysis (Kaplan-Meier curve shown in Figure 1). In model 1 of the Cox regression analysis, male gender (hazard ratio [HR]: 3.16 [95% CI: 1.22–8.17]; P=0.0174), fulfilment of the imaging arm (HR: 6.64 [1.37–32.25]; P=0.0188), and good response to NSAIDs, (HR: 4.66 [1.23–17.71]; P=0.0237), were significantly associated with progression to r-axSpA (Figure 1). In model 2, HLA-B27 positivity showed a significant association with progression (HR: 3.99 [1.10–14.49]; P=0.0353; Figure 1).ConclusionIn this study, 16% of nr-axSpA pts progressed to r-axSpA within 5 years. The mean time to disease progression was 2.4 years. Predictors of radiographic progression were male gender, good response to NSAIDs, and fulfilment of the imaging arm as well as HLA-B27 positivity.References[1]Poddubnyy D. et al, Rheumatology (Oxford). 2021; doi: 10.1093/rheumatology/keab901Disclosure of InterestsDenis Poddubnyy Speakers bureau: AbbVie, Bristol Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer, Joachim Sieper Speakers bureau: AbbVie, Janssen, Merck, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Servet Akar Speakers bureau: AbbVie, Lilly, MSD, Novartis, Pfizer, Roche, Janssen, and UCB, Consultant of: AbbVie, Lilly, MSD, Novartis, Pfizer, Roche, Janssen, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, Pfizer, Roche, Janssen, and UCB, Santiago Muñoz-Fernández Speakers bureau: AbbVie, BMS, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant of: AbbVie, BMS, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Grant/research support from: AbbVie, BMS, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Hildrun Haibel Speakers bureau: AbbVie, Janssen, MSD, Pfizer, Sobi, Novartis, and Roche, Consultant of: Boehringer, Janssen, MSD, Novartis, and Roche, Torsten Diekhoff Paid instructor for: Novartis, MSD, Canon MS, Consultant of: Eli Lilly, Mikhail Protopopov: None declared, Elisabeth Altmaier Consultant of: AbbVie, Fabiana Ganz Shareholder of: Owns AbbVie stock or stock options., Employee of: AbbVie, Robert Inman Consultant of: AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, and Sandoz, Grant/research support from: AbbVie, Amgen, and Janssen

Additional file 1: Detailed description of the monitoring process in RABBIT-SpA.

Supplemental material, sj-docx-1-tab-10.1177_1759720X211057975 for Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) by Denis Poddubnyy, Xenofon Baraliakos, Filip Van den Bosch, J��rgen Braun, Laura C. Coates, Vinod Chandran, Torsten Diekhoff, Floris A. van Gaalen, Lianne S. Gensler, Niti Goel, Alice B. Gottlieb, D��sir��e van der Heijde, Philip S. Helliwell, Kay Geert A. Hermann, Deepak Jadon, Robert G. Lambert, Walter P. Maksymowych, Philip Mease, Peter Nash, Fabian Proft, Mikhail Protopopov, Joachim Sieper, Murat Torgutalp and Dafna D. Gladman in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-docx-2-tab-10.1177_1759720X211057975 for Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) by Denis Poddubnyy, Xenofon Baraliakos, Filip Van den Bosch, J��rgen Braun, Laura C. Coates, Vinod Chandran, Torsten Diekhoff, Floris A. van Gaalen, Lianne S. Gensler, Niti Goel, Alice B. Gottlieb, D��sir��e van der Heijde, Philip S. Helliwell, Kay Geert A. Hermann, Deepak Jadon, Robert G. Lambert, Walter P. Maksymowych, Philip Mease, Peter Nash, Fabian Proft, Mikhail Protopopov, Joachim Sieper, Murat Torgutalp and Dafna D. Gladman in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-docx-1-tab-10.1177_1759720X20987700 for Sustained clinical response and safety of etanercept in patients with early axial spondyloarthritis: 10-year results of the ESTHER trial by Fabian Proft, Anja Weiß, Murat Torgutalp, Mikhail Protopopov, Valeria Rios Rodriguez, Hildrun Haibel, Olaf Behmer, Joachim Sieper and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-docx-2-tab-10.1177_1759720X211057975 for Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) by Denis Poddubnyy, Xenofon Baraliakos, Filip Van den Bosch, J��rgen Braun, Laura C. Coates, Vinod Chandran, Torsten Diekhoff, Floris A. van Gaalen, Lianne S. Gensler, Niti Goel, Alice B. Gottlieb, D��sir��e van der Heijde, Philip S. Helliwell, Kay Geert A. Hermann, Deepak Jadon, Robert G. Lambert, Walter P. Maksymowych, Philip Mease, Peter Nash, Fabian Proft, Mikhail Protopopov, Joachim Sieper, Murat Torgutalp and Dafna D. Gladman in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-docx-1-tab-10.1177_1759720X20987700 for Sustained clinical response and safety of etanercept in patients with early axial spondyloarthritis: 10-year results of the ESTHER trial by Fabian Proft, Anja Weiß, Murat Torgutalp, Mikhail Protopopov, Valeria Rios Rodriguez, Hildrun Haibel, Olaf Behmer, Joachim Sieper and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-pdf-3-tab-10.1177_1759720X20972610 for The impact of extra-musculoskeletal manifestations on disease activity, functional status, and treatment patterns in patients with axial spondyloarthritis: results from a nationwide population-based study by Imke Redeker, Britta Siegmund, Kamran Ghoreschi, Uwe Pleyer, Johanna Callhoff, Falk Hoffmann, Ursula Marschall, Hildrun Haibel, Joachim Sieper, Angela Zink and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Additional file 1: A univariable association of comorbidities with disease activity and functional impairment in patients with axial spondyloarthritis (N=1,776). Results from univariable linear regression models analysing the association of comorbidities with a prevalence >5% with disease activity and functional impairment.

Supplemental material, sj-pdf-1-tab-10.1177_1759720X20972610 for The impact of extra-musculoskeletal manifestations on disease activity, functional status, and treatment patterns in patients with axial spondyloarthritis: results from a nationwide population-based study by Imke Redeker, Britta Siegmund, Kamran Ghoreschi, Uwe Pleyer, Johanna Callhoff, Falk Hoffmann, Ursula Marschall, Hildrun Haibel, Joachim Sieper, Angela Zink and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-pdf-2-tab-10.1177_1759720X20972610 for The impact of extra-musculoskeletal manifestations on disease activity, functional status, and treatment patterns in patients with axial spondyloarthritis: results from a nationwide population-based study by Imke Redeker, Britta Siegmund, Kamran Ghoreschi, Uwe Pleyer, Johanna Callhoff, Falk Hoffmann, Ursula Marschall, Hildrun Haibel, Joachim Sieper, Angela Zink and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-pdf-4-tab-10.1177_1759720X20972610 for The impact of extra-musculoskeletal manifestations on disease activity, functional status, and treatment patterns in patients with axial spondyloarthritis: results from a nationwide population-based study by Imke Redeker, Britta Siegmund, Kamran Ghoreschi, Uwe Pleyer, Johanna Callhoff, Falk Hoffmann, Ursula Marschall, Hildrun Haibel, Joachim Sieper, Angela Zink and Denis Poddubnyy in Therapeutic Advances in Musculoskeletal Disease

Introduction: Long-term data on anti-TNF treatment in patients with early axial spondyloarthritis (SpA) is scarce. The objective of this analysis was to assess the long-term clinical efficacy (up to 10 years of treatment) of a tumor necrosis factor (TNF) inhibitor etanercept (ETN) in patients with early[for full text, please go to the a.m. URL], Deutscher Rheumatologiekongress 2020, 48. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 34. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh)

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Objective : Inflammatory back pain (IBP), the key symptom of axial spondyloarthritis (axSpA), including ankylosing spondylitis, has been proposed as a screening test for patients presenting with chronic back pain in primary care. The diagnostic accuracy of IBP in the rheumatology setting is unknown. Methods: Six rheumatology centres, representing secondary and tertiary rheumatology care, included routinely referred patients with consecutive chronic back pain with suspicion of axSpA. IBP (diagnostic test) was assessed in each centre by an independent (blinded) rheumatologist; a second (unblinded) rheumatologist made the diagnosis (axSpA or no-axSpA), which served as reference standard. Results: Of 461 routinely referred patients, 403 received a final diagnosis. IBP was present in 67.3%, and 44.6% (180/403) were diagnosed as axSpA. The sensitivity of IBP according to various definitions (global judgement, Calin, Berlin, Assessment of SpondyloArthritis international Society criteria for IBP) was 74.4%-81.1 % and comparable to published figures, whereas the specificity was unexpectedly low (25.1%-43.9%). The resulting positive likelihood ratios (LR+) were 1.1-1.4 and without major differences between sets of IBP criteria. The presence of IBP according to various definitions increased the probability of axSpA by 2.5%-8.4% only (from 44.6% to 47.1%-53.0%). Conclusions: The diagnostic utility of IBP in the rheumatology setting was smaller than expected. However, this was counterbalanced by a high prevalence of IBP among referred patients, demonstrating the effective usage of IBP in primary care as selection parameter for referral to rheumatology. Notably, this study illustrates potential shifts in specificity and LR+ of diagnostic tests if these tests are used to select patients for referral.

Table S1. Individual data on treatment, responsiveness, NK cell counts per μl blood, and frequencies related to total leukocytes. Moreover, absolute numbers and frequencies of CD8-positive NK cells in relation to all CD56/CD16-double positive NK cells are given. n.d. not determined. (DOCX 25 kb)

Figure S1. Clarification of the gating strategy for NK cells shown in Fig. 2. By backgating, monocytes can be clearly separated from NK cells (Gate A, PBMC; Gate B, CD3/CD19-double negative PBMC; Gate C, monocytes; and Gate D, NK cells). (DOC 87 kb)

Introduction There is some evidence that non-steroidal anti-inflammatory drugs (NSAIDs), in particular celecoxib, might possess not only a symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS), retarding the progression of structural damage in the spine if taken continuously. In contrast, this remains controversial for tumour necrosis factor alpha (TNF-α) inhibitors, despite their good clinical efficacy. The impact of a combined therapy (a TNF inhibitor plus an NSAID) on radiographic spinal progression in AS is unclear. Methods and analysis The aim of this study is to evaluate the impact of treatment with an NSAID (celecoxib) when added to a TNF inhibitor (golimumab) compared with TNF inhibitor (golimumab) alone on progression of structural damage in the spine over 2 years in patients with AS. The study consists of a 6-week screening period, a 12-week period (phase I: run-in phase) of treatment with golimumab for all subjects followed by a 96-week controlled treatment period (phase II: core phase) with golimumab plus celecoxib versus golimumab alone, and a safety follow-up period of 4 weeks. At week 108, the primary study endpoint radiographic spinal progression (as assessed by the change in the modified Stoke Ankylosing Spondylitis Spine Score after 2 years) will be evaluated. Ethics and dissemination The study will be performed according to the principles of good clinical practice and the German drug law. The written approval of the independent ethics committee and of the German federal authority have been obtained. On study completion, results are expected to be published in a peer- reviewed journal. Trial registration number ClinicalTrials.gov register (NCT02758782) and European Union Clinical Trials Register (EudraCT No 2016-000615-33).

Background: This analysis assessed, on a group level, whether there is a long-term advantage for early RA patients treated with adalimumab (ADA) + MTX vs those initially treated with placebo (PBO) + MTX who either responded to therapy or added ADA following inadequate response (IR). Methods: OPTIMA was a 78- week, randomized, controlled trial of ADA + MTX vs PBO + MTX in MTX-naïve early (

List of Ethics Committees. (DOCX 27 kb)