Control of Inflammation and Sustained Improvements in Patient‐Reported Outcomes in Patients With Psoriatic Arthritis: Bimekizumab Two‐Year Results From Two Phase 3 Studies

Journal article

Objective: To assess two‐year impact of bimekizumab on patient‐reported outcomes (PROs), and their association with objective measures of inflammation, in patients with psoriatic arthritis (PsA) who were biologic disease‐modifying antirheumatic drug (bDMARD)‐naïve or had tumor necrosis factor inhibitor inadequate response or intolerance (TNFi‐IR). Methods: BE OPTIMAL (NCT03895203; bDMARD‐naïve) and BE COMPLETE (NCT03896581; TNFi‐IR) were phase 3 studies that assessed subcutaneous bimekizumab 160 mg every four weeks. Both were double‐blind, placebo‐controlled to week16, then placebo patients switched to bimekizumab. BE OPTIMAL week52 or BE COMPLETE week16 completers could enter BE VITAL (NCT04009499; open‐label extension), where all patients received bimekizumab. PROs, disease impact (Psoriatic Arthritis Impact of Disease‐12 questionnaire [PsAID‐12]), and their association with inflammation (assessed using swollen joint count [SJC]) are reported to year 2. Results: Among 712 bDMARD‐naïve and 400 TNFi‐IR patients, bimekizumab resulted in long‐term sustained improvements in PROs for pain, fatigue, and function (Health Assessment Questionnaire–Disability Index) to year 2. Mean change from baseline (year 2) in bimekizumab‐randomized patients for pain and disease impact (PsAID‐12) was −33.9 to −29.2 and −2.5 to −2.2, respectively. An achievement of SJC = 0 was associated with the greatest reduction in pain. Decreased SJC was associated with improved pain, fatigue, function, and reduced disease impact to year 2. By year 2, 44.4% to 54.3% of patients originally randomized to placebo or bimekizumab reported no or low disease impact (PsAID‐12 ≤1.95), and 88.0% to 92.0% of bimekizumab‐randomized patients achieved a patient acceptable symptom state for disease impact (PsAID‐12 ≤4), associated with concurrent improvement in SJC and skin involvement. Conclusion: Bimekizumab treatment resulted in sustained clinically meaningful improvements in PROs and reduced disease impact to two years in bDMARD‐naïve and TNFi‐IR patients with PsA. Stringent inflammation control was associated with symptom relief and reduced disease impact. image

Authors: Gossec, L; Tillett, W; Coates, LC; Mease, PJ; de Wit, M

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Wiley
• Journal: ACR Open Rheumatology
• Volume: 8
• Issue: 5
• Article number: e90053
• Publication date: 2026-05-18
• Acceptance date: 2026-03-30
• DOI: 10.1002/acr2.90053
• EISSN: 2578-5745
• ISSN: 2578-5745
• Language: English