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Objective: To identify predictors of flare in a 2-year follow-up study of patients with rheumatoid arthritis (RA) in sustained clinical remission tapering towards withdrawal of biological disease-modifying anti-rheumatic drugs (bDMARDs)., Methods: Sustained clinical remission was defined as Disease Activity Score for 28 joints (DAS28)-C reactive protein (CRP) ≤2.6 without radiographic progression for >1 year. bDMARDs were tapered according to a mandatory clinical guideline to two-thirds of standard dose at baseline, half of dose at week 16 and discontinuation at week 32. Prospective assessments for 2 years included clinical evaluation, conventional radiography, ultrasound and MRI for signs of inflammation and bone changes. Flare was defined as DAS28-CRP ≥2.6 with ∆DAS28-CRP ≥1.2 from baseline. Baseline predictors of flare were assessed by logistic regression analyses., Results: Of 142 included patients, 121 (85%) flared during follow-up of which 86% regained remission within 24 weeks after flare. Patients that flared were more often rheumatoid factor positive, had tried more bDMARDs and had higher baseline ultrasound synovitis sum scores than those not flaring. For patients on standard dose, predictors of flare within 16 weeks after reduction to two-thirds of standard dose were baseline MRI-osteitis (OR 1.16; 95% CI 1.03 to 1.33; p=0.014), gender (female) (OR 6.71; 95% CI 1.68 to 46.12; p=0.005) and disease duration (OR 1.06; 95% CI 1.01 to 1.11; p=0.020). Baseline predictors for flare within 2 years were ultrasound grey scale synovitis sum score (OR 1.19; 95% CI 1.02 to 1.44; p=0.020) and number of previous bDMARDs (OR 4.07; 95% CI 1.35 to 24.72; p=0.007)., Conclusion: The majority of real-world patients with RA tapering bDMARDs flared during tapering, with the majority regaining remission after stepwise dose increase. Demographic and imaging parameters (MR-osteitis/ultrasound greyscale synovitis) were independent predictors of immediate flare and flare overall and may be of importance for clinical decision-making in patients eligible for tapering., Competing Interests: Competing interests: LT: Speakers fee from Janssen, Roche, Novartis, Pfizer, UCB and Eli-Lilly, consultancy fee from Janssen. MO: research support, consultancy fees and/or speaker fees form Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galapagos, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. LJ: Speakers fees and consultancy fees from AbbVie, Eli-Lilly, and Novartis. UMO: consultancy fees from Eli-Lilly, Roche, Novartis, speakers fee from Roche. SK: research support from AbbVie, MSD and Novartis. DG: Speakers fee from Eli-Lilly; AH: speakers fee from Eli-Lilly; KA: speakers fees and advisory board membership fees from AbbVie, Cellgene, Pfizer, Novartis, Roche, Berlin Chemie, Eli-Lilly and MSD; MB: research support, consultancy fees and/or speaker fees from Image Analysis Group, Esaote, Abbvie, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer, UCB, Novo, GSK, Takeda, Geurbet, Biogen, Radiobotics, Chondrometrics. MLH: grants from Bristol-Myers Squibb, AbbVie, Roche and Novartis, grants and personal fees from MSD, Biogen, and Pfizer, and personal fees from Eli-Lilly, Orion Pharma, CellTrion, Samsung Bioepis, Janssen Biologics B.V., (© 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.)

Objectives: To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries., Methods: Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI))., Results: We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness., Conclusions: In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries., Competing Interests: Competing interests: BM: consultancy fees and research grant from Novartis. UL: None. CC: None. AC: fees for speaking and/or consulting from AbbVie, Celgene, Eli Lilly, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer and UCB. JZ: none. AGL: research grant from Novartis, consultant for/served on the speakers bureau for AbbVie, MSD, Novartis, Pfizer, Roche, and UCB. MP-S: speaker and consultancy fees from Abbvie, BMS, Janssen, Lilly, MSD and Sanofi. FO: speaker and consultancy fees from Abbvie, Abdi Ibrahim, Amgen, Celltrion, Eli Lilly, Novartis, Pfizer, Roche and UCB and research grant from Pfizer. TKK: fees for speaking and/or consulting from AbbVie, Amgen, Biogen, Celltrion, Egis, Eli Lilly, Hikma, MSD, Mylan, Novartis/Sandoz, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sanofi and UCB and received research funding to Diakonhjemmet Hospital from AbbVie, BMS, MSD, Pfizer, Roche and UCB. ZR: speaker and consultancy fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi. MJS: speaker fees from Novartis and Pfizer. FI: speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD. AMH: research grant from MSD. BG: Speaker fee from Novartis. JA: none. RI: consulting fees from Abbvie, Eli-Lilly, Ewopharma, Novartis, Pfizer, Roche, Sandoz. MJN: fees for speaking and/or consulting from AbbVie, Celgene, Eli Lilly, Novartis and Pfizer. KP: honoraria for lectures from MSD, BMS, AbbVie, UCB, Roche, Biogen, Amgen, Novartis, Pfizer, Medac, Egis. CS-P: none. SA: has received grant/research support from, been a consultant for, and served on the speakers bureau for AbbVie, MSD, Novartis, Pfizer, Roche, and UCB. JS: none. MT: none. HS: speaker fees from Novartis, Pfizer and Abbvie. MS: none. JÖ: none. AjG: None. GM: none. IvdH-B: Fees for speaking and/or consulting from Abbvie, Lilly, Novartis, BMS, MSD, UCB and Pfizer. SG: none. CHB: research grant from Novartis. LØ: research grant from Novartis. MH: grant from AbbVie, Biogen, BMS, Novartis, Pfizer, UCB. Personal fee from CellTrion, MSD, Orion, Samsung. MO: consultancy fees and/or speaker fees form Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB; and research support from Abbvie, BMS, Celgene, Merck, and Novartis., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)