PMID- 35853675 OWN - NLM STAT- MEDLINE DCOM- 20220721 LR - 20220923 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 8 IP - 2 DP - 2022 Jul TI - Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. LID - 10.1136/rmdopen-2021-002165 [doi] LID - e002165 AB - OBJECTIVES: To study the efficacy and safety of ixekizumab (IXE) in patients with radiographic (r-) and non-radiographic (nr-)axial spondyloarthritis (axSpA) for up to 116 weeks. METHODS: COAST-Y (NCT03129100) is the 2-year extension study following COAST-V, COAST-W and COAST-X. Patients were treated with either 80 mg IXE every 4 weeks or 2 weeks, as assigned in the originating studies. Efficacy was assessed in all participants continuously treated with IXE through week 116 and in subgroups based on disease subtype and dosing. Missing data were handled by non-responder imputation for categorical variables and modified baseline observation carried forward for continuous variables. Safety data were analysed in all patients having received >/=1 IXE dose. RESULTS: Of 932 patients who received >/=1 IXE dose, 773 enrolled in COAST-Y (82.9%); 665 of which (86.0%) completed week 116. Of 352 continuously treated patients, the proportion achieving Assessment of Spondyloarthritis International Society (ASAS40) at week 52 was 51.4%, which increased to 56.0% at week 116. The proportion of patients achieving ASAS40 at week 116 was 64.9% and 57.7% for biological disease-modifying antirheumatic drug (bDMARD)-naive patients with r-axSpA and nr-axSpA, respectively, and 47.0% for TNFi-experienced patients. The proportion of patients achieving Ankylosing Spondylitis Disease Activity Score <2.1 through week 116 was 57.0% and 52.9% for bDMARD-naive patients with r-axSpA and nr-axSpA, respectively, and 33.6% for TNFi-experienced patients. Incidences of treatment-emergent adverse events and serious adverse events were consistent with previous reports. CONCLUSION: IXE treatment led to sustained long-term improvements in patients with axSpA, with similar efficacy for r-axSpA and nr-axSpA, and for patients receiving the approved every 4 weeks dose. The safety profile of IXE was consistent with previous reports. No new safety signals were identified. CI - (c) 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. FAU - Braun, Jurgen AU - Braun J AUID- ORCID: 0000-0002-9156-5095 AD - Rheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universitat, Bochum, Germany juergen.braun@elisabethgruppe.de. FAU - Kiltz, Uta AU - Kiltz U AUID- ORCID: 0000-0001-5668-4497 AD - Rheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universitat, Bochum, Germany. FAU - Deodhar, Atul AU - Deodhar A AD - Division of Arthritis and Rheumatic Diseases, School of Medicine, Oregon Health & Science University, Portland, Oregon, USA. FAU - Tomita, Tetsuya AU - Tomita T AD - Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. FAU - Dougados, Maxime AU - Dougados M AUID- ORCID: 0000-0003-3009-6229 AD - Department of Rheumatology, Hopital Cochin, Paris, France. FAU - Bolce, Rebecca AU - Bolce R AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Sandoval, David AU - Sandoval D AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Lin, Chen-Yen AU - Lin CY AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Walsh, Jessica AU - Walsh J AD - Division of Rheumatology, University of Utah, Salt Lake City, Utah, USA. LA - eng SI - ClinicalTrials.gov/NCT03129100 PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - BTY153760O (ixekizumab) SB - IM MH - *Antibodies, Monoclonal, Humanized/adverse effects MH - *Antirheumatic Agents/adverse effects MH - *Axial Spondyloarthritis/therapy MH - Humans MH - Treatment Outcome PMC - PMC9301795 OTO - NOTNLM OT - Antirheumatic Agents OT - Biological Therapy OT - Patient Reported Outcome Measures OT - Spondylitis, Ankylosing COIS- Competing interests: JB has received compensation as a speaker, adviser, or consultant for, or has received grant support from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Fresenius, GlaxoSmithKline, Gilead, Hexal, Janssen, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB. MD has received compensation as a consultant or adviser for, and has received grant support from Abbvie, Biogen, Eli Lilly and Company, Galapagos, Merck, Pfizer and UCB. UK has received compensation as a consultant, adviser, or speaker for Abbvie, Eli Lilly and Company, Hexal, Janssen, MSD, Novartis, Pfizer, UCB and Viatris; and has received grant support from Amgen, Hexal and Novartis. AD has received compensation as a consultant, adviser or speaker for Abbvie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, GlaxoSmithKilne, Janssen, Novartis, Pfizer and UCB; has received travel, grant, or research support from Abbvie, Eli Lilly and Company, GlaxoSmithKline, Novartis, Pfizer and UCB; and serves as a member of the GRAPPA steering committee. TT has received compensation as a consultant and adviser for Eli Lilly and Company; and as a speaker for Abbvie, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer. JW has received compensation as a consultant for Abbvie, Amgen, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB; has received grant or travel support from Abbvie, Eli Lilly and Company, Merck, and Pfizer. DS, and CL are full-time employees and shareholders of Eli Lilly and Company. RB is an employee and shareholder of Eli Lilly and Company; has received travel support for and has received compensation as an adviser for Eli Lilly and Company. EDAT- 2022/07/20 06:00 MHDA- 2022/07/22 06:00 PMCR- 2022/07/19 CRDT- 2022/07/19 21:02 PHST- 2021/12/16 00:00 [received] PHST- 2022/05/23 00:00 [accepted] PHST- 2022/07/19 21:02 [entrez] PHST- 2022/07/20 06:00 [pubmed] PHST- 2022/07/22 06:00 [medline] PHST- 2022/07/19 00:00 [pmc-release] AID - rmdopen-2021-002165 [pii] AID - 10.1136/rmdopen-2021-002165 [doi] PST - ppublish SO - RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.