Trial reportRheumatology (Oxford, England)2026
Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies.
Trial report in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Authors and funding
15 authors.
Funding
Abstract
objectivesBimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has demonstrated tolerability and clinical efficacy in patients with PsA. Here, we report an additional year of safety and efficacy of bimekizumab treatment to 3 years.
methodsBE OPTIMAL [NCT03895203; biologic DMARD (bDMARD)-naïve] and BE COMPLETE [NCT03896581; prior inadequate response/intolerance to TNF inhibitors (TNFi-IR)] assessed s.c. bimekizumab 160 mg every 4 weeks in patients with PsA. Study completers could enrol in the BE VITAL open-label extension (NCT04009499). Outcomes were reported as observed, or using modified non-responder or multiple imputation, to 3 years.
resultsOverall, 546/299 (76.7/74.8%) bDMARD-naïve/TNFi-IR patients randomized to bimekizumab or placebo at baseline (Bimekizumab Total group) completed year 3. Treatment-emergent adverse event rates [exposure-adjusted incidence rate/100 patient-years (95% CI)] for bimekizumab-treated patients through 3 years were 164.2 (152.7-176.3) in bDMARD-naïve and 88.6 (79.1-98.9) in TNFi-IR patients, consistent with those at year 1 with no new safety signals identified. Response rates for efficacy outcomes were sustained up to 3 years; at year 1 and year 3, respectively, 56.1/50.4% and 53.2/55.2% of bDMARD-naïve/TNFi-IR patients achieved ACR50, 61.8/58.2% and 59.5/59.1% achieved swollen joint count resolution, and 64.7/66.2% and 61.9/67.5% had 100% improvement from baseline in Psoriasis Area and Severity Index. Responses for other efficacy measures were similarly sustained and consistent in bDMARD-naïve and TNFi-IR patients.
conclusionBimekizumab demonstrated sustained high levels of efficacy and tolerability to 3 years, supporting its suitability for long-term treatment in bDMARD-naïve and TNFi-IR patients with PsA.
trial registrationBE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499.
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Registered trials
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