{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T16:10:05Z","timestamp":1788711005937,"version":"build-2803163510"},"reference-count":47,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T00:00:00Z","timestamp":1773100800000},"content-version":"unspecified","delay-in-days":68,"URL":"https:\/\/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":[[2025,11,23]]},"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To present updated integrated safety analyses of bimekizumab in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety data pooled from six phase IIb\/III studies in axSpA and PsA (data-cut: July 2023 for phase III) reported for patients who received \u22651\u2009dose of bimekizumab 160\u2009mg every 4 weeks. Treatment-emergent adverse events (TEAEs) were reported using exposure-adjusted incidence rate per 100 patient-years (EAIR\/100 PY).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>848 patients with axSpA (total exposure: 2513.8 PY) and 1409 patients with PsA (3655.9 PY) were included. TEAE incidence (EAIR\/100 PY) was 129.6 in axSpA and 126.9 in PsA. Study discontinuations due to TEAEs were infrequent (EAIR\/100 PY for axSpA: 2.4; PsA: 2.9). The most frequent TEAEs were SARS-CoV-2 (COVID-19) infection (EAIR\/100 PY for axSpA: 9.9; PsA: 9.9), nasopharyngitis (EAIR\/100 PY for axSpA: 8.4; PsA: 6.8) and upper respiratory tract infection (EAIR\/100 PY for axSpA: 5.0; PsA: 5.7). EAIR\/100 PY for oral candidiasis was 3.5 in axSpA and 3.8 in PsA; most cases were mild\/moderate, with few leading to study discontinuation (EAIR\/100 PY for axSpA: 0.2; PsA: 0.3). Serious opportunistic infections were infrequent (EAIR\/100 PY for axSpA: 0; PsA: 0.1), with no active tuberculosis. EAIR\/100 PY for hepatic events was 5.3 in axSpA and 5.0 in PsA. EAIRs for 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                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>TEAE EAIRs were similar between axSpA and PsA. Bimekizumab demonstrated tolerability up to 5 years (2 years in phase III); no new safety signals were identified.<\/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>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03355573\">NCT03355573<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03928704\">NCT03928704<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03928743\">NCT03928743<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04436640\">NCT04436640<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02969525\">NCT02969525<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03347110\">NCT03347110<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03895203\">NCT03895203<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03896581\">NCT03896581<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04009499\">NCT04009499<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2025-006174","type":"journal-article","created":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T16:56:02Z","timestamp":1773161762000},"page":"e006174","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb\/III clinical studies"],"prefix":"10.1136","volume":"12","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":"nct02963506","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03928704","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02963506","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":"nct02969525","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":"nct03355573","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04436640","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03347110","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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Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Poddubnyy","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine, University of Toronto and University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Gastroenterology, Infectious Diseases and Rheumatology, Charit\u00e9\u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"Department of Epidemiology, German Rheumatism Research Centre, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lebwohl","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajan","family":"Bajracharya","sequence":"additional","affiliation":[{"name":"UCB, Slough, 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Medicine\/Rheumatology, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,3,10]]},"reference":[{"key":"2026090304051152000_12.1.e006174.1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221035"},{"key":"2026090304051152000_12.1.e006174.2","doi-asserted-by":"crossref","first-page":"2273","DOI":"10.1016\/S0140-6736(18)30830-4","article-title":"The pathogenesis of psoriatic arthritis","volume":"391","author":"Veale","year":"2018","journal-title":"The Lancet"},{"key":"2026090304051152000_12.1.e006174.3","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2023-003063","article-title":"Axial spondyloarthritis and psoriatic arthritis: mostly overlapping or substantially different diseases?","volume":"9","author":"Braun","year":"2023","journal-title":"RMD 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