Efficacy and safety of benvitimod 1% cream for atopic dermatitis in patients aged 2 years and older: A phase III randomized clinical trial.

IF 7.3 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Chinese Medical Journal Pub Date : 2025-09-16 DOI:10.1097/CM9.0000000000003769

Yan Zhao, Zhu Wei, Yanyan Feng, Lin Ma, Danhong Jiao, Yong Cui, Jun Gu, Kunpeng Bian, Chao Ci, Jianjian Zhu, Tiechi Lei, Yujie Shi, Xiaohua Tao, Xiuping Han, Xiaoli Zhang, Litao Zhang, Ying Li, Genhui Chen, Jianzhong Zhang

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引用次数: 0

Abstract

Background: Benvitimod (tapinarof), an aryl hydrocarbon receptor (AhR) agonist approved for treating plaque psoriasis, is being investigated as a potential treatment for atopic dermatitis (AD). The aim of this study was to evaluate the efficacy and safety of benvitimod 1% cream in patients aged 2 years or older with AD.

Methods: This randomized controlled trial enrolled 271 Chinese patients with AD aged ≥2 years, who received either benvitimod 1% cream (n = 183) or vehicle cream (n = 88) twice daily for 8 weeks in a 2:1 ratio at 35 sites in China from June to November 2023. The primary endpoint was the proportion of patients achieving a 75% improvement in the Eczema Area and Severity Index (EASI) 75 at week 8. Secondary endpoints included achievement of Investigator's Global Assessment (IGA) scores of 0/1, 90% EASI improvement (EASI 90), and ≥3-point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS). Treatment-emergent adverse events (TEAEs) were monitored for safety evaluation. Furthermore, a subset of patients (n = 43) opted into a 44-week open-label extension.

Results: At week 8, a significantly higher proportion of patients treated with benvitimod achieved EASI 75 compared to those receiving vehicle (54.4% [n = 183] vs. 25.5% [n = 88]; P <0.001). The benvitimod group also showed superior results across all secondary endpoints: IGA 0/1 (46.2% [n = 183] vs. 21.4% [n = 88]; P <0.001), EASI 90 (33.9% [58/171] vs. 13.5% [10/74]; P <0.001), and ≥3-point decrease in PP-NRS (54.0% [47/87] vs. 27.9% [12/43]; P <0.01). TEAEs occurred in 51.4% (94/183) of benvitimod-treated patients vs. 43.2% (38/88) of vehicle-treated patients, with most events being mild to moderate in severity.

Conclusion: Benvitimod 1% cream demonstrated favorable efficacy and safety in adult and pediatric patients with AD, supporting its potential as a novel topical treatment option.

Trial registration: chinadrugtrials.org.cn, CTR20231413.

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1%苯维莫德乳膏治疗2岁及以上患者特应性皮炎的疗效和安全性：一项III期随机临床试验

背景：本维莫德（tapinarof）是一种被批准用于治疗斑块型银屑病的芳烃受体（AhR）激动剂，目前正在研究其作为特应性皮炎（AD）的潜在治疗方法。本研究的目的是评估1%苯维莫德乳膏对2岁及以上AD患者的疗效和安全性。方法：该随机对照试验招募了271名年龄≥2岁的中国AD患者，他们于2023年6月至11月在中国35个地点以2:1的比例每天两次接受1%本维莫德乳膏（n = 183）或替代乳膏（n = 88），持续8周。主要终点是在第8周湿疹面积和严重程度指数（EASI） 75改善75%的患者比例。次要终点包括研究者总体评估（IGA）得分达到0/1，EASI改善90% (EASI 90)，峰值瘙痒数值评定量表（PP-NRS）降低≥3分。监测治疗中出现的不良事件（teae）以进行安全性评估。此外，一部分患者（n = 43）选择了44周的开放标签延长治疗。结果：在第8周，与接受对照治疗的患者相比，接受本维莫德治疗的患者达到EASI 75的比例明显更高（54.4% [n = 183]对25.5% [n = 88]）。结论：本维莫德1%乳膏在成人和儿童AD患者中显示出良好的疗效和安全性，支持其作为一种新的局部治疗选择的潜力。试验注册：chinadrutrials.org, CTR20231413。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chinese Medical Journal 医学-医学：内科

CiteScore

9.80

自引率

4.90%

发文量

19245

审稿时长

6 months

期刊介绍： The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.