ArticleDermatology and therapy2025
Efficacy and Safety of Bimekizumab in Japanese Patients with Generalised Pustular Psoriasis and Erythrodermic Psoriasis: 3-Year Results from BE BRIGHT, a Multicentre, Open-Label, Phase 3 Study.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03598790 (A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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10 authors.
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Abstract
introductionThis study aimed to report bimekizumab (BKZ) efficacy and safety in Japanese patients with generalised pustular psoriasis (GPP) and erythrodermic psoriasis (EP).
methodsPatients aged ≥ 18 years with plaque psoriasis, GPP, or EP received BKZ for 144 weeks; only results for GPP and EP reported here. All patients received BKZ 320 mg every 4 weeks (Q4W) at week 0, with dose adjustments for Q4W or Q8W at weeks 16 and 48, depending on Investigator's Global Assessment (IGA) 0/1 response. Efficacy outcomes assessed to week 144: IGA 0/1, Dermatology Life Quality Index (DLQI) 0/1, Clinical Global Impressions-Improvement (CGI-I), ≥ 75/90/100% improvement from baseline Psoriasis Area and Severity Index (PASI 75/90/100), ≥ 75/90/100% improvement from baseline modified Nail Psoriasis Severity Index (mNAPSI 75/90/100), and patient-reported outcomes; GPP-specific outcomes: Japanese Dermatological Association (JDA) severity index and Global Improvement Score (GIS). Treatment emergent adverse events (TEAEs) evaluated through weeks 0-144 and safety follow-up.
resultsAt week 144, most patients with GPP (8/10) and EP (10/11) completed the study. At week 16, all patients reported efficacy outcomes improving with BKZ, generally persisting through week 144. At week 144 (missing visit: 1 GPP), 6/7 patients with GPP and 8/10 with EP achieved IGA 0/1; 5/7 and 9/10 patients achieved DLQI 0/1; 7/7 and 9/10 patients achieved CGI-I response ("improved"/"remission"); and 6/7 and 9/10 patients achieved PASI 90, respectively; 2/5 patients with GPP and 4/9 with EP achieved week 144 mNAPSI 100. Among patients with GPP, JDA severity index generally decreased and improvements in GIS were sustained to week 144. Serious TEAEs were observed in 2/10 patients with GPP and 5/11 with EP; BKZ was well tolerated with low incidence of TEAEs leading to study discontinuation (2 GPP, 1 EP).
conclusionsLong-term BKZ treatment over 3 years improved signs and symptoms of GPP and EP; these were sustained through week 144. No new safety signals were identified.
trial registrationClinicalTrials.gov identifier, NCT03598790.
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