{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T00:14:12Z","timestamp":1786407252155,"version":"build-2736575974"},"reference-count":39,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,4,5]],"date-time":"2025-04-05T00:00:00Z","timestamp":1743811200000},"content-version":"unspecified","delay-in-days":4,"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":[[2025,1,2]]},"published-print":{"date-parts":[[2025,4]]},"abstract":"\n Objective<\/jats:title>\n To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Safety data pooled from six integrated phase IIb\/III studies in axSpA and PsA are reported (to the July 2022 data-cut for phase III) for patients who received \u22651\u2009dose of BKZ 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rate per 100 patient-years (EAIR\/100 PY).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The axSpA and PsA safety pools included 848 (total BKZ exposure: 2034.4 PY) and 1407 patients (2590.8 PY), respectively. TEAEs occurred at an EAIR\/100 PY of 136.9 in axSpA and 139.6 in PsA; study discontinuation due to TEAEs was low (axSpA: 2.7\/100 PY; PsA: 3.1\/100 PY). The three most frequently reported TEAEs were SARS-CoV-2 (COVID-19) infection (axSpA: 7.8\/100 PY; PsA: 8.8\/100 PY), nasopharyngitis (axSpA: 8.2\/100 PY; PsA: 7.7\/100 PY) and upper respiratory tract infection (axSpA: 5.0\/100 PY; PsA: 5.6\/100 PY). EAIR\/100 PY of oral candidiasis was 3.7 in axSpA and 4.2 in PsA; most events were mild\/moderate. EAIR of BKZ discontinuation due to oral candidiasis was low (both axSpA and PsA: 0.3\/100 PY). No systemic fungal infections or cases of active tuberculosis were reported. EAIRs of adjudicated definite\/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation\/behaviour were low.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods. No new safety signals were identified.<\/jats:p>\n <\/jats:sec>\n \n Trial registration numbers<\/jats:title>\n \n NCT02963506<\/jats:ext-link> (BE AGILE); NCT03355573<\/jats:ext-link> (BE AGILE 2); NCT03928704<\/jats:ext-link> (BE MOBILE 1); NCT03928743<\/jats:ext-link> (BE MOBILE 2); NCT04436640<\/jats:ext-link> (BE MOVING); NCT02969525<\/jats:ext-link> (BE ACTIVE); NCT03347110<\/jats:ext-link> (BE ACTIVE 2); NCT03895203<\/jats:ext-link> (BE OPTIMAL); NCT03896581<\/jats:ext-link> (BE COMPLETE); NCT04009499<\/jats:ext-link> (BE VITAL).<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-005026","type":"journal-article","created":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T02:45:11Z","timestamp":1743993911000},"page":"e005026","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb\/III clinical studies"],"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":"nct03928704","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03928743","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04436640","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02969525","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03347110","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03895203","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03896581","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04009499","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":"nct02969525","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03347110","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03928704","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03928743","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04436640","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03895203","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03896581","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04009499","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":"nct03928704","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03928743","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04436640","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02969525","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03347110","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03895203","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03896581","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04009499","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6620-0457","authenticated-orcid":false,"given":"Philip 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