Efficacy and safety of benvitimod 1% cream for atopic dermatitis in patients aged 2 years and older: A phase III randomized clinical trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Chinese Medical Journal
Authors: 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, On behalf of study group
Institutions: Peking University People's Hospital, Hunan Children's Hospital, Chengdu Second People's Hospital, Capital Medical University, Beijing Children’s Hospital, China-Japan Friendship Hospital, Shanghai Tenth People's Hospital, First Affiliated Hospital of Wannan Medical College, Central South University, The First People's Hospital of Changde, Wuhan University, Second Affiliated Hospital of Guangzhou Medical University, Zhejiang Provincial People's Hospital, Sheng Jing Hospital, China Medical University, Wuxi No.2 People's Hospital, Qilu Hospital of Shandong University
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
OpenAlex ID: W4414288224