{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T22:42:07Z","timestamp":1792190527751,"version":"4.4.0"},"reference-count":31,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T00:00:00Z","timestamp":1708560000000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2024,1,10]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response\/intolerance to tumour necrosis factor inhibitors.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03896581\">NCT03896581<\/jats:ext-link>) study entered the open-label extension, BE VITAL (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04009499\">NCT04009499<\/jats:ext-link>). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 347\/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate\/100 patient-years for \u22651 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to \u200d52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo\/bimekizumab patients (receiving bimekizumab from week 16 to 52) had \u226550% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo\/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo\/bimekizumab patients at week 52.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2023-003855","type":"journal-article","created":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T21:10:36Z","timestamp":1708636236000},"page":"e003855","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":39,"title":["Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"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\/0000-0002-4756-663X","authenticated-orcid":false,"given":"Laura C","family":"Coates","sequence":"first","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0577-6620","authenticated-orcid":false,"given":"Robert","family":"Landew\u00e9","sequence":"additional","affiliation":[{"name":"Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland, MC, Heerlen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6462-4280","authenticated-orcid":false,"given":"Iain B","family":"McInnes","sequence":"additional","affiliation":[{"name":"College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6620-0457","authenticated-orcid":false,"given":"Philip J","family":"Mease","sequence":"additional","affiliation":[{"name":"College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2602-1219","authenticated-orcid":false,"given":"Christopher T","family":"Ritchlin","sequence":"additional","affiliation":[{"name":"Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"The First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, 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University Health Network, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4528-310X","authenticated-orcid":false,"given":"Laure","family":"Gossec","sequence":"additional","affiliation":[{"name":"INSERM, Institut Pierre Louis d'Epid\u00e9miologie et de Sant\u00e9 Publique, Sorbonne Universit\u00e9, Paris, France"},{"name":"Rheumatology Department, AP-HP, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8644-8567","authenticated-orcid":false,"given":"Ana-Maria","family":"Orbai","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice B","family":"Gottlieb","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Icahn 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