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作者

Cheng Zhou Yan Zhao Guannan Zhu Liming Wu Yi Liu Xiaohua Tao Hengguang Zhao Zhu Wei Wei Lu Weiquan Li Yangfeng Ding Xiaohong Zhu Guohong Hu Hao Cheng Rong Xiao Xiaoyong Man Qi Wang Shanshan Li Tongxiang Zeng Lihua Wang Yufeng Xu Libo Zhang Wei Liu Guoqing Zhao Yingmin Jia Yanqiu Huang Bo Chen Jianzhong Zhang

作者单位

²Department of Dermatology, Dermatology Hospital, Southern Medical University , Guangzhou , Guangdong, China ⁴Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital , Chongqing , China ⁵Center for Plastic & Reconstructive Surgery, Department of Dermatology, Zhejiang Provincial People's Hospital (Affiliated People’s Hospital, Hangzhou Medical College) , Hangzhou , Zhejiang, China ¹⁰Department of Dermatology, Wuxi No ¹¹Department of Dermatology, Dermatology Hospital of Jiangxi Province , Nanchang , Jiangxi, China ⁶Department of Dermatology, The Second Affiliated Hospital of Chongqing Medical University , Chongqing , China ⁷Department of Dermatology, The Affiliated Children's Hospital of Xiangya School of Medicine, Hunan Children’s Hospital, Central South University , Changsha , Hunan, China ¹⁷Department of Dermatology, Jingzhou Hospital Affiliated to Yangtze University , Jingzhou, Hubei, China People’s Hospital (Jiangnan University Medical Center) , Wuxi, Jiangsu , China ¹⁹Keymed Biosciences (Chengdu) Co., Ltd , Chengdu, Sichuan , China ¹²Department of Dermatology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University , Hangzhou , Zhejiang, China ¹⁴Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine , Hangzhou , Zhejiang, China ¹Department of Dermatology, Peking University People’s Hospital , Beijing , China ³Department of Dermatology, Affiliated Hangzhou First People’s Hospital, School of Medicine, Westlake University , Hangzhou , Zhejiang, China ⁹Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine , Shanghai , China ⁸Department of Dermatology, Yuebei People’s Hospital , Shaoguan, Guangdong, China ¹⁶Department of Dermatology, The First Hospital of Jilin University , Changchun , Jilin, China ¹⁸Department of Dermatology, Central Hospital Affiliated to Shandong First Medical University , Jinan , Shandong, China ¹⁵Department of Dermatology, Hangzhou Third People’s Hospital , Hangzhou , Zhejiang, China ¹³Department of Dermatology & Venerology, The Second Xiangya Hospital of Central South University , Changsha , Hunan, China

刊名

British Journal of Dermatology

ISSN

0007-0963

摘要

Background Moderate-to-severe atopic dermatitis imposes a significant burden on adolescents and their families, leading to a substantial reduction in quality of life, while treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody targeting IL-4Rα, has been approved for the treatment of adults with moderate-to-severe AD in China. Objectives To evaluate the efficacy and safety of stapokibart in adolescents with moderate-to-severe AD. Methods In this randomized, do...更多

Background Moderate-to-severe atopic dermatitis imposes a significant burden on adolescents and their families, leading to a substantial reduction in quality of life, while treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody targeting IL-4Rα, has been approved for the treatment of adults with moderate-to-severe AD in China. Objectives To evaluate the efficacy and safety of stapokibart in adolescents with moderate-to-severe AD. Methods In this randomized, double-blind, placebo-controlled phase 3 trial , eligible patients were randomized to stapokibart 300 mg or placebo for 18 weeks. Patients with a baseline weight ≥60 kg received subcutaneous stapokibart or placebo every two weeks , while those weighting 30 to <60 kg received treatment every three weeks . All patients were given moisturizers during the whole study. Coprimary endpoints were proportions of patients achieving a ≥75% improvement from baseline in Eczema Area and Severity Index and an Investigator's Global Assessment score of 0/1 with ≥2-point reduction from baseline at week 18. The safety was also assessed. Results Of the 180 enrolled patients, 120 received stapokibart and 60 received placebo . Totally 178 patients completed the double-blind treatment. At week 18, higher proportions of stapokibart- vs. placebo-treated patients achieved EASI-75 and an IGA response . The proportion of patients achieving ≥4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in stapokibart group than in placebo group . The incidence of adverse events was similar between the stapokibart and placebo groups. No conjunctivitis was found. Conclusion Stapokibart demonstrated high efficacy and favorable safety in adolescents with moderate-to-severe AD.收起

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