{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T18:26:37Z","timestamp":1779215197787,"version":"3.51.4"},"reference-count":31,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,9,22]],"date-time":"2024-09-22T00:00:00Z","timestamp":1726963200000},"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":[[2024,7,25]]},"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To assess impact of bimekizumab treatment on patient-reported outcomes and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA), using 16-week data from two phase 3 studies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>BE OPTIMAL (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03895203\">NCT03895203<\/jats:ext-link>; biologic disease-modifying antirheumatic drug (bDMARD)-na\u00efve) and BE COMPLETE (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03896581\">NCT03896581<\/jats:ext-link>; tumour necrosis factor inhibitor inadequate response\/intolerance (TNFi-IR)) are phase 3 studies of subcutaneous bimekizumab 160\u2009mg Q4W; both were double-blind and placebo-controlled to 16 weeks. Patients were randomised 3:2:1 to bimekizumab, placebo or reference (subcutaneous adalimumab 40\u2009mg Q2W) in BE OPTIMAL; 2:1 to bimekizumab or placebo in BE COMPLETE. Patient-reported outcomes for pain, fatigue, physical function and HRQoL are reported to week 16 using pooled and individual study data for bimekizumab and placebo patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>1073\/1112 (96.5%) patients completed week 16 (bimekizumab:\u200d 677\/698 [97.0%]; placebo: 396\/414 [95.7%]). Bimekizumab-treated patients achieved rapid improvements vs placebo in pain, fatigue, physical function and HRQoL by week 4, after a single dose. Improvements continued to week 16 for all patient-reported outcomes, including Pain Visual Analogue Scale (VAS; mean (95%\u2009CI) change from baseline: bimekizumab: \u2013\u200d25.2 [\u201327.2, \u201323.1]; placebo:\u200d \u2013\u200d5.7 [\u20138.2, \u20133.3]) and FACIT-Fatigue (bimekizumab: 4.5 [3.9, 5.1]; placebo: 1.1 [0.3, 2.0]); both nominal p&lt;0.001. Greater proportions of bimekizumab-treated patients achieved minimal clinically important differences for patient-reported symptoms vs placebo, including FACIT-Fatigue (bimekizumab: 53.1%; placebo: 36.3%) and HAQ-DI (bimekizumab:\u200d 53.0%; placebo: 28.7%); both nominal p&lt;0.001.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Bimekizumab treatment demonstrated rapid and greater improvements in patient-reported pain, fatigue, physical function and HRQoL to week 16 vs placebo in bDMARD-na\u00efve and TNFi-IR patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03895203\">NCT03895203<\/jats:ext-link>; <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03896581\">NCT03896581<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-004464","type":"journal-article","created":{"date-parts":[[2024,9,23]],"date-time":"2024-09-23T08:55:20Z","timestamp":1727081720000},"page":"e004464","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct03895203","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03896581","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":"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":[{"given":"M Elaine","family":"Husni","sequence":"first","affiliation":[{"name":"Department of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, Ohio, USA"},{"name":"Orthopedic and Rheumatologic Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, 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UK"},{"name":"Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadine","family":"Goldammer","sequence":"additional","affiliation":[{"name":"UCB, Monheim am Rhein, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Ink","sequence":"additional","affiliation":[{"name":"UCB, Slough, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Coarse","sequence":"additional","affiliation":[{"name":"UCB, Morrisville, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00e9r\u00e9my","family":"Lambert","sequence":"additional","affiliation":[{"name":"UCB, Colombes, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Taieb","sequence":"additional","affiliation":[{"name":"UCB, Colombes, 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