Michelsen B, Lindström U, Codreanu C, Ciurea A, Zavada J, Loft AG, Pombo-Suarez M, Onen F, Kvien TK, Rotar Z, Santos MJ, Iannone F, Hokkanen AM, Gudbjornsson B, Askling J, Ionescu R, Nissen MJ, Pavelka K, Sanchez-Piedra C, Akar S, Sexton J, Tomsic M, Santos H, Sebastiani M, Österlund J, Geirsson AJ, Macfarlane G, van der Horst-Bruinsma I, Georgiadis S, Brahe CH, Ørnbjerg LM, Hetland ML, and Østergaard M
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.)