{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T18:50:36Z","timestamp":1793731836611,"version":"4.6.1"},"reference-count":33,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T00:00:00Z","timestamp":1738281600000},"content-version":"unspecified","delay-in-days":30,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011110","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011110","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2024,12,18]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160\u2009mg every 4 weeks. Safety (exposure-adjusted incidence rates\/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From Weeks 0\u2013256, 289\/303 (95.4%) patients had \u22651 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 (<jats:italic>Candida<\/jats:italic> infections: 2.6; oral candidiasis: 2.2); none systemic. EAIR of serious infections was 1.4; no active tuberculosis was reported. Active inflammatory bowel disease and anterior uveitis EAIRs were 0.8 and 0.7, respectively. 202\/303 (66.7%) patients completed Week 256. 42 (13.9%) patients discontinued treatment due to TEAEs.<\/jats:p>\n                  <jats:p>Efficacy at Week 48 was maintained for 5 years. At Week 256, NRI analysis showed 49.7% (OC: 73.1%) and 41.6% (OC: 71.1%) of patients achieved Assessment of SpondyloArthritis International Society 40% (ASAS40) response and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity, respectively. Mean (SE; MI) ASDAS improved from 3.9 (0.1) at baseline to 2.1 (0.1) at Week 48, which was maintained to Week 256. Improvements in pain, fatigue, physical function and health-related quality of life were sustained.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration numbers<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02963506\">NCT02963506<\/jats:ext-link>; <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03355573\">NCT03355573<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-005081","type":"journal-article","created":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T12:05:41Z","timestamp":1738325141000},"page":"e005081","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02963506","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03355573","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02963506","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03355573","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03355573","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02963506","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03355573","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Atul","family":"Deodhar","sequence":"first","affiliation":[{"name":"Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon, 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