文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

BE VIVID研究:乌司奴单抗和安慰剂对照的3期研究中,比美吉珠单抗在日本斑块状银屑病患者中的疗效和安全性

Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study.

作者信息

Asahina Akihiko, Okubo Yukari, Morita Akimichi, Tada Yayoi, Igarashi Atsuyuki, Langley Richard G, Deherder Delphine, Matano Mizuho, Vanvoorden Veerle, Wang Maggie, Ohtsuki Mamitaro, Nakagawa Hidemi

机构信息

Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.

Department of Dermatology, Tokyo Medical University, Tokyo, Japan.

出版信息

Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.


DOI:10.1007/s13555-022-00883-y
PMID:36648594
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9984664/
Abstract

INTRODUCTION: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. METHODS: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. RESULTS: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. CONCLUSION: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. TRIAL REGISTRATION: NCT03370133.

摘要

简介:在一项为期52周的3期随机、优特克单抗和安慰剂对照研究BE VIVID中,比美吉珠单抗治疗使中度至重度斑块状银屑病患者的临床结局得到改善。我们展示了BE VIVID日本患者亚组的数据。 方法:在全球范围内,患者被随机分配接受每4周一次的320 mg比美吉珠单抗(Q4W)、优特克单抗(基线和第4周时根据体重给予45/90 mg,然后每12周一次)或安慰剂(第16周前每4周一次,然后每4周一次给予320 mg比美吉珠单抗)。疗效终点包括第16周的银屑病面积和严重程度指数(PASI)90以及研究者整体评估(IGA)0/1,以及其他结局指标[PASI 100、PASI 75、IGA 0、皮肤病生活质量指数(DLQI)0/1、绝对PASI、头皮IGA、银屑病症状和影响测量(P-SIM)反应]。进行了安全性分析。 结果:有108名日本随机分组患者(比美吉珠单抗组:62名;优特克单抗组:29名;安慰剂组:17名)。在第16周时,接受比美吉珠单抗治疗的患者与接受优特克单抗和安慰剂治疗的患者相比,临床反应更高(PASI 90:85.5%对51.7%和5.9%;IGA 0/1:82.3%对48.3%和0.0%)。在52周内,比美吉珠单抗维持了改善的临床反应,包括在第16周从安慰剂组转换过来的患者。总体而言,日本患者的安全性特征与全球人群中观察到的一致。 结论:与优特克单抗和安慰剂相比,比美吉珠单抗使临床反应得到改善,并且在日本患者中耐受性良好。 试验注册:NCT03370133

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/3935b04b5c34/13555_2022_883_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/2b3f942524dc/13555_2022_883_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/34dd9a3c2f78/13555_2022_883_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/3935b04b5c34/13555_2022_883_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/2b3f942524dc/13555_2022_883_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/34dd9a3c2f78/13555_2022_883_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7de/9984664/3935b04b5c34/13555_2022_883_Fig3_HTML.jpg

相似文献

[1]
Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study.

Dermatol Ther (Heidelb). 2023-3

[2]
Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial.

Lancet. 2021-2-6

[3]
Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials.

Br J Dermatol. 2023-2-22

[4]
Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.

J Dermatol. 2024-11

[5]
Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial.

Br J Dermatol. 2023-1-23

[6]
Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial.

Lancet. 2021-2-6

[7]
Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials.

Ther Adv Chronic Dis. 2023-4-4

[8]
Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial.

J Dermatol. 2011-9-29

[9]
Secukinumab dosing every 2 weeks demonstrated superior efficacy compared with dosing every 4 weeks in patients with psoriasis weighing 90 kg or more: results of a randomized controlled trial.

Br J Dermatol. 2022-6

[10]
Bimekizumab versus Adalimumab in Plaque Psoriasis.

N Engl J Med. 2021-7-8

引用本文的文献

[1]
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.

Dermatol Ther (Heidelb). 2025-8-11

[2]
New and Emerging Treatments for Generalized Pustular Psoriasis: Focus on IL-36 Receptor Inhibitors.

Pharmaceutics. 2024-7-6

[3]
Response to Biologic Therapy in Skin of Colour Participants With Moderate-to-Severe Psoriasis and Atopic Dermatitis: A Systematic Review.

J Cutan Med Surg. 2024

[4]
A case of scalp psoriasis resistant to ixekizumab treated with bimekizumab.

JAAD Case Rep. 2023-7-3

本文引用的文献

[1]
Bimekizumab versus Secukinumab in Plaque Psoriasis.

N Engl J Med. 2021-7-8

[2]
Bimekizumab versus Adalimumab in Plaque Psoriasis.

N Engl J Med. 2021-7-8

[3]
Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Psoriasis Treatment: A Retrospective Multi-Country, Multicentric Cohort Study.

Am J Clin Dermatol. 2021-7

[4]
Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial.

Lancet. 2021-2-6

[5]
Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial.

Lancet. 2021-2-6

[6]
Blockade of the IL-17 signaling pathway increased susceptibility of psoriasis patients to superficial fungal infections.

J Dermatol Sci. 2021-2

[7]
Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.

J Am Acad Dermatol. 2020-11

[8]
Disease activity and treatment efficacy using patient-level Psoriasis Area and Severity Index scores from tildrakizumab phase 3 clinical trials.

J Dermatolog Treat. 2022-2

[9]
Japanese guidance for use of biologics for psoriasis (the 2019 version).

J Dermatol. 2020-1-8

[10]
Patient preference for biologic treatments of psoriasis in Japan.

J Dermatol. 2019-4-15

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索