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作者

Zhao Yan Zhang Jianzhong Yang Bin Li Jingyi Ding Yangfeng Wu Liming Zhang Litao Wang Jinyan Zhu Xiaohong Zhang Furen Tao Xiaohua Li Yumei Zhang Chunlei Li Linfeng Lu Jianyun Diao Qingchun Lu Qianjin Man Xiaoyong Li Fuqiu Xia Xiujuan Cheng Hao Jia Yingmin Zhao Guoqing Yan Jinchun Chen Bo

作者单位

¹Department of Dermatology；²Peking University People’s Hospital；³Beijing 100044；⁴China；⁵Dermatology Hospital；⁶Southern Medical University；⁷Guangzhou；⁸Guangdong 510091；⁹West China Hospital；¹⁰Sichuan University；¹¹Chengdu；¹²Sichuan 610041；¹³Shanghai Skin Disease Hospital；¹⁴Institute of Psoriasis；¹⁵Tongji University School of Medicine；¹⁶Shanghai 200443；¹⁷Affiliated Hangzhou First People’s Hospital；¹⁸Zhejiang University School of Medicine；¹⁹Hangzhou；²⁰Zhejiang 310006；²¹Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital；²²Tianjin 300120；²³Ningbo No Hospital；²⁴Ningbo；²⁵Zhejiang 315010；²⁶The Wuxi Second Affiliated Hospital of Nanjing Medical University；²⁷Wuxi；²⁸Jiangsu 214002；²⁹Shandong Provincial Hospital for Skin Diseases &；³⁰Shandong Provincial Institute of Dermatology and Veneorology；³¹Shandong First Medical University &；³²Shandong Academy of Medical Sciences；³³Jinan；³⁴Shandong 250022；³⁵Center for Plastic &；³⁶Reconstructive Surgery；³⁷Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital；³⁸Hangzhou Medical College)；³⁹Zhejiang 310014；⁴⁰Affiliated Hospital of Jiangsu University；⁴¹Zhenjiang；⁴²Jiangsu 212001；⁴³Peking University Third Hospital；⁴⁴Beijing 100191；⁴⁵Beijing Friendship Hospital；⁴⁶Capital Medical University；⁴⁷Beijing 100050；⁴⁸The Third Xiangya Hospital of Central South University；⁴⁹Changsha；⁵⁰Hunan 410013；⁵¹Chongqing Traditional Chinese Medicine Hospital；⁵²Chongqing 400011；⁵³Hunan Key Laboratory of Medical Epigenomics；⁵⁴The Second Xiangya Hospital of Central South University；⁵⁵Hunan 410011；⁵⁶The Second Affiliated Hospital；⁵⁷Zhejiang 310009；⁵⁸The Second Hospital of Jilin University；⁵⁹Changchun；⁶⁰Jilin 130041；⁶¹Qingdao University Medical College Affiliated Yantai Yuhuangding Hospital；⁶²Yantai；⁶³Shandong 264000；⁶⁴Sir Run Run Shaw Hospital；⁶⁵School of Medicine；⁶⁶Zhejiang University；⁶⁷Zhejiang 310016；⁶⁸Clinical Department；⁶⁹Keymed Biosciences (Chengdu) Limited；⁷⁰Sichuan 610219

刊名

中华医学杂志英文版

年份

2024

卷号

第137卷

期号

第2期

ISSN

0366-6999

关键词

CM310 Moderate-to-severe atopic dermatitis Interleukin-4 receptor alpha Adults

分类号

R758.2

摘要

Background: Atopic dermatitis affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods: This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 1...更多

Background: Atopic dermatitis affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods: This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index score from baseline at week 16. Safety and pharmacodynamics were also studied.Results: At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups than that in the placebo group . The differences in EASI-75 response rate were 50% and 45% , with bothP values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310.Conclusion: CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration: ClinicalTrials.gov, NCT04805411.收起

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