Dermatology and therapy · 2025
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.
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Okubo Yukari, Tada Yayoi, Takahashi Hidetoshi, Abe Masatoshi, Yamanaka Keiichi, Tilt Nicola, Cross Nancy, Deherder Delphine, Matano Mizuho, Nakagawa Hidemi
Аннотация
INTRODUCTION: This study aimed to report bimekizumab (BKZ) efficacy and safety in Japanese patients with generalised pustular psoriasis (GPP) and erythrodermic psoriasis (EP).
METHODS: Patients 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.
RESULTS: At 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).
CONCLUSIONS: Long-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 REGISTRATION: ClinicalTrials.gov identifier, NCT03598790.
METHODS: Patients 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.
RESULTS: At 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).
CONCLUSIONS: Long-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 REGISTRATION: ClinicalTrials.gov identifier, NCT03598790.