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. 2025 Aug 11.
doi: 10.1007/s13555-025-01509-9. Online ahead of print.

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

Yukari Okubo  1 , Yayoi Tada  2 , Hidetoshi Takahashi  3 , Masatoshi Abe  4 , Keiichi Yamanaka  5 , Nicola Tilt  6 , Nancy Cross  7 , Delphine Deherder  8 , Mizuho Matano  9 , Hidemi Nakagawa  10
Affiliations

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

Yukari Okubo et al. Dermatol Ther (Heidelb). .

Abstract

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.

Keywords: Anti-interleukin-17; Bimekizumab; Erythrodermic psoriasis; Generalised pustular psoriasis; Japan.

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Conflict of interest statement

Declarations. Conflict of Interest: Yukari Okubo: Received research funding from AbbVie, Eisai, Maruho, Shiseido, Sun Pharma, and Torii Pharmaceutical; honoraria as a speaker, consultant, and advisory board member from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Kyowa Kirin, LEO Pharma, Eli Lilly, Maruho, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho Pharma, and UCB; and honoraria as a speaker from Eisai, Jimro, Mitsubishi Tanabe Pharma, and Torii Pharmaceutical. Yayoi Tada: Research grants from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Jimro, Kaken Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Meiji Seika Pharma, Sun Pharma, Taiho Pharma, Mitsubishi Tanabe Pharma, Torii Pharmaceutical, and UCB; honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Eisai, Janssen Pharma, Jimro, Kyowa Kirin, LEO Pharma, Maruho, Novartis, Sun Pharma, Taiho Pharma, Mitsubishi Tanabe Pharma, Torii Pharmaceutical, and UCB. Hidetoshi Takahashi: Served as paid speaker sponsored by AbbVie, Amgen, Eli Lilly, Janssen, Kaken Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Sanofi, Sato Pharmaceutical, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB. Masatoshi Abe: Served as paid speaker sponsored by AbbVie, Amgen, Eli Lilly, Kyowa Kirin, Maruho, Novartis, Sanofi, Torii Pharmaceutical, and UCB. Keiichi Yamanaka: Grants from Kaken Pharmaceutical, Maruho, Nihon Pharmaceutical, Nippon Kayaku, Otshuka Pharmaceutical, Sasaki Chemical, Sun Pharma, and Torii Pharmaceutical; speaker for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Eisai, Eli Lilly, Janssen, Kaken Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Nippon Kayaku, Nobelpharma, Novartis, Otshuka Pharmaceutical, Pfizer, Sanofi, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB. Nicola Tilt, Nancy Cross, Delphine Deherder: Employees and shareholders of UCB. Mizuho Matano: Employee of UCB. Hidemi Nakagawa: Consulting fees and/or speaker’s fees from Japan Tobacco Inc., Maruho, Otsuka Pharmaceutical, Torii Pharmaceutical, and UCB. Ethical Approval: This study protocol was reviewed by a central institutional review board (IRB, approval number MOD01178825) and the IRB of each institution prior to implementation. Written informed consent was obtained from all patients. The study was carried out in accordance with the applicable regulatory and International Council for Harmonisation-Good Clinical Practice requirements, and the Helsinki Declaration of 1964, and its later amendments.

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