ArticleDermatology and therapy2026
Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year.
Article in Dermatology and therapy, 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 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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11 authors.
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Abstract
introductionIndividuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] > 0).
methodsWe conducted a post hoc analysis of BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE COMPLETE/BE VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160 mg every 4 weeks (Q4W), placebo or reference arm (adalimumab 40 mg Q2W; BE OPTIMAL only). At week 16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE COMPLETE week 16 could enter BE VITAL. Efficacy and safety data are reported by study to week 52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).
resultsOverall, 263 (placebo n = 88; bimekizumab n = 133; reference [adalimumab] n = 42) biologic-naïve and 159 (placebo n = 54; bimekizumab n = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week 16 to week 52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week 16 to week 52 after receiving 36 weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week 52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).
conclusionsBimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article.
trial registrationBE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTrials.gov).
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