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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.)

Objectives: To investigate time trends in baseline characteristics and retention, remission and response rates in bio-naïve axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients initiating TNF inhibitor (TNFi) treatment., Methods: Prospectively collected data on bio-naïve axSpA and PsA patients from routine care in 15 European countries were pooled. Three cohorts were defined according to year of TNFi initiation: A (1999-2008), B (2009-2014) and C (2015-2018). Retention, remission and response rates were assessed at 6, 12 and 24 months., Results: In total, 27 149 axSpA and 17 446 PsA patients were included. Cohort A patients had longer disease duration compared with B and C. In axSpA, cohort A had the largest proportion of male and HLA-B27 positive patients. In PsA, baseline disease activity was highest in cohort A. Retention rates in axSpA/PsA were highest in cohort A and differed only slightly between B and C. For all cohorts, disease activity decreased markedly from 0 to 6 months. In axSpA, disease activity at 24 months was highest in cohort A, where also remission and response rates were lowest. In PsA, remission rates at 6 and 12 months tended to be lowest in cohort A. Response rates were at all time points comparable across cohorts, and less between-cohort disease activity differences were seen at 24 months., Conclusion: Our findings indicate that over the past decades, clinicians have implemented more aggressive treatment strategies in spondyloarthritis. This was illustrated by shorter disease duration at treatment initiation, decreased retention rates and higher remission rates during recent years., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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.)

Objective: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi)., Methods: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months., Results: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%-76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014., Conclusion: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year., Competing Interests: Competing interests: LMØ: Novartis; CHB: Novartis; JA: has entered into agreements with Abbvie, BMS, Lilly, Merck, Pfizer, Roche, Samsung Bioepis, and UCB, mainly for safety monitoring via the Swedish ARTIS system, and received a travel reimbursement from Novartis. Karolinska Institutet has received remuneration for JA’s participation in meetings arranged by Pfizer and by Lilly; AC: AbbVie, Celgene, Eli Lilly, Janssen-Cilag, MSD, Novartis, Pfizer and UCB; HM: AbbVie, MSD, Novartis, Pfizer, Sanofi; FO: Abbvie, Novartis, Pfizer, Roche, UCB; EKK: none; DN: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, UCB; MJS: Abbvie, Biogen, Roche, Lilly, Pfizer, Novartis; Catalin Codreanu: AbbVie, Amgen, Angellini, Astra Zeneca, BMS, Egis, MSD, Pfizer, Richter, Roche, Sanofi, Servier, Teva, UCB, Zentiva; JGR: none; ZR: speaker or consulting fees from Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche. BioRx.si has received funding for clinical research paid to Društvo za razvoj revmatologije from AbbVie, Celgene, Celtrion, Eli Lilly, Johnson & Johnson, Medis, MSD, Novartis, Pfizer and Roche; BG: Amgen, Novartis, Pfizer; MJN: Abbvie, Lilly, Pfizer, Novartis; KP: AbbVie, Roche, Pfizer, Amgen, Sanofi, Egis, BMS, UCB, MSD, Eli Lilly; TKK: AbbVie, Biogen, BMS, Celltrion, Egis, Eli Lilly, MSD, Mylan, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, Sanofi and UCB; AB: Abbvie, Lilly, MSD, Novartis, Pfizer; MT: Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche; FI: BMS, Pfizer, Abbvie, UCB, Roche, Celgene, Eli-Lilly, Hospira, Janssen, Merck; LHH: Novartis; MØ: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB; MLH: Abbvie, Biogen, BMS, CellTrion, MSD, Novartis, Orion, Pfizer, Samsung, UCB., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)