比美吉珠单抗治疗日本泛发性脓疱型银屑病和红皮病型银屑病患者的疗效和安全性：多中心、开放标签、3期BE BRIGHT研究的3年结果
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.
作者信息
Okubo Yukari, Tada Yayoi, Takahashi Hidetoshi, Abe Masatoshi, Yamanaka Keiichi, Tilt Nicola, Cross Nancy, Deherder Delphine, Matano Mizuho, Nakagawa Hidemi
机构信息
Department of Dermatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
出版信息
Dermatol Ther (Heidelb). 2025 Aug 11. doi: 10.1007/s13555-025-01509-9.
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.
引言
本研究旨在报告比美吉珠单抗（BKZ）在日本泛发性脓疱型银屑病（GPP）和红皮病型银屑病（EP）患者中的疗效和安全性。
方法
年龄≥18岁的斑块状银屑病、GPP或EP患者接受BKZ治疗144周；本文仅报告GPP和EP的结果。所有患者在第0周每4周（Q4W）接受320mg BKZ治疗，在第16周和第48周根据研究者整体评估（IGA）0/1反应调整为Q4W或Q8W剂量。评估至第144周的疗效指标：IGA 0/1、皮肤病生活质量指数（DLQI）0/1、临床总体印象改善（CGI-I）、银屑病面积和严重程度指数（PASI）较基线改善≥75/90/100%、改良甲银屑病严重程度指数（mNAPSI）较基线改善≥75/90/100%，以及患者报告的结局；GPP特异性指标：日本皮肤病协会（JDA）严重程度指数和总体改善评分（GIS）。通过第0至144周评估治疗中出现的不良事件（TEAE）并进行安全性随访。
结果
在第144周，大多数GPP患者（8/10）和EP患者（10/11）完成了研究。在第16周，所有患者报告BKZ治疗使疗效指标得到改善，且通常持续至第144周。在第144周（1例GPP患者失访），7例GPP患者中的6例和10例EP患者中的8例达到IGA 0/1；7例中的5例和10例中的9例达到DLQI 0/1；7例中的7例和10例中的9例达到CGI-I反应（“改善”/“缓解”）；7例中的6例和10例中的9例分别达到PASI 90；5例GPP患者中的2例和9例EP患者中的4例在第144周达到mNAPSI 100。在GPP患者中，JDA严重程度指数总体下降，GIS改善持续至第144周。2/10例GPP患者和5/11例EP患者观察到严重TEAE；BKZ耐受性良好，导致研究停药的TEAE发生率较低（2例GPP，1例EP）。
结论
超过3年的长期BKZ治疗改善了GPP和EP的体征和症状；这些改善持续至第144周。未发现新的安全信号。
试验注册
ClinicalTrials.gov标识符，NCT03598790。
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