vunakizumab在中国不同地区中重度斑块型银屑病患者中的疗效和安全性:一项随机对照III期试验的事后探索性分析

IF 3.9
Kejian Zhu, Qiaoli Zheng, Yingjie Zhu, Xia Wu, Hao Cheng
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引用次数: 0

摘要

背景:Vunakizumab(抗白细胞介素- 17a抗体)治疗中重度斑块型银屑病已显示出良好的疗效和安全性。银屑病的发病率和严重程度在中国不同地区有所不同。目的:本事后探索性分析旨在探讨vunakizumab在中国不同地区中重度斑块型银屑病患者中的疗效和安全性。方法:这项回顾性探索性分析使用了一项III期试验(NCT04839016)的数据,461名接受vunakizumab治疗的患者被分为华北组(n = 118)、华中组(n = 252)和华南组(n = 91)。结果:在第12周(W12),三组患者的银屑病面积和严重程度指数(PASI)75/90/100和静态医师整体评估(sPGA) 0/1缓解率相似。此外,W12-W52组间持续PASI 75/90/100和sPGA 0/1的缓解率也相似。在三组患者报告的结果中,包括皮肤病学生活质量指数、瘙痒数值评定量表、EuroQol-5D和short form-36,均有类似的改善。华北组、华中组和华南组不良事件发生率分别为80.5%、90.1%和90.1%。结论:中国不同地区对vunakizumab治疗中重度斑块型银屑病的疗效和安全性没有影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China: a post-hoc exploratory analysis of a phase III, randomized controlled trial.

Background: Vunakizumab (anti-interleukin-17A antibody) has shown favorable efficacy and safety in treating moderate-to-severe plaque psoriasis. The morbidity and severity of psoriasis vary in different regions of China.

Objective: This post-hoc exploratory analysis aims to investigate the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China.

Methods: This post-hoc exploratory analysis used data from a phase III trial (NCT04839016), with 461 patients receiving vunakizumab categorized into North (n = 118), Central (n = 252), and South (n = 91) China groups.

Results: Psoriasis area and severity index (PASI)75/90/100 and static physician's global assessment (sPGA) 0/1 response rates were similar among the three groups at week 12 (W12). Additionally, W12-W52 sustained PASI 75/90/100 and sPGA 0/1 response rates were also similar among groups. Similar improvements in patient-reported outcomes, including dermatology life quality index, itch-numerical rating scale, EuroQol-5D, and short form-36, were observed in the three groups. The incidence of adverse events was 80.5%, 90.1%, and 90.1% in the North, Central, and South China groups, respectively.

Conclusion: The efficacy and safety of vunakizumab are not affected by different regions of China in patients with moderate-to-severe plaque psoriasis.

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