Scholarlink

Introduction <p>This study aimed to report bimekizumab (BKZ) efficacy and safety in Japanese patients with generalised pustular psoriasis (GPP) and erythrodermic psoriasis (EP).</p> Methods <p>Patients aged ≥ 18&#xa0;years with plaque psoriasis, GPP, or EP received BKZ for 144&#xa0;weeks; only results for GPP and EP reported here. All patients received BKZ 320&#xa0;mg every 4&#xa0;weeks (Q4W) at week&#xa0;0, with dose adjustments for Q4W or Q8W at weeks&#xa0;16 and 48, depending on Investigator’s Global Assessment (IGA)&#xa0;0/1 response. Efficacy outcomes assessed to week&#xa0;144: IGA&#xa0;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&#xa0;75/90/100), ≥ 75/90/100% improvement from baseline modified Nail Psoriasis Severity Index (mNAPSI&#xa0;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&#xa0;0–144 and safety follow-up.</p> Results <p>At week&#xa0;144, most patients with GPP (8/10) and EP (10/11) completed the study. At week&#xa0;16, all patients reported efficacy outcomes improving with BKZ, generally persisting through week&#xa0;144. At week&#xa0;144 (missing visit: 1 GPP), 6/7 patients with GPP and 8/10 with EP achieved IGA&#xa0;0/1; 5/7 and 9/10 patients achieved DLQI&#xa0;0/1; 7/7 and 9/10 patients achieved CGI-I response (“improved”/“remission”); and 6/7 and 9/10 patients achieved PASI&#xa0;90, respectively; 2/5 patients with GPP and 4/9 with EP achieved week&#xa0;144 mNAPSI&#xa0;100. Among patients with GPP, JDA severity index generally decreased and improvements in GIS were sustained to week&#xa0;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&#xa0;GPP, 1&#xa0;EP).</p> Conclusions <p>Long-term BKZ treatment over 3&#xa0;years improved signs and symptoms of GPP and EP; these were sustained through week&#xa0;144. No new safety signals were identified.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT03598790.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年8月11日

查看全文
  • Yukari Okubo,
  • Yayoi Tada,
  • Hidetoshi Takahashi,
  • Masatoshi Abe,
  • Keiichi Yamanaka,
  • Nicola Tilt,
  • Nancy Cross,
  • Delphine Deherder,
  • Mizuho Matano,
  • Hidemi Nakagawa

摘要

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.