Long-Term Stapokibart Treatment Induces Sustained Clinical Improvements in Patients With Moderate-to-Severe Atopic Dermatitis

<u><b><i></i></b></u> <u><b><i>Background:</i></b></u> Stapokibart has been approved for the treatment of adults with atopic dermatitis (AD) in China. <u><b><i>Objective:</i></b></u> To report long-term efficacy of stapokibart in patients with moderate-to-severe AD. <u><b><i>Methods:</i></b></u> This post hoc analysis included 237 adult patients from a phase 3 trial (NCT05265923) who received stapokibart 300 mg (loading dose, 600 mg) every 2 weeks during the 16-week double-blind period and continued with the same dose of stapokibart in the subsequent 36-week maintenance period. <u><b><i>Results:</i></b></u> At week 20, 100% and 92.2% of patients who achieved coprimary endpoints (≥75% improvement in Eczema Area and Severity Index [EASI-75] and Investigator's Global Assessment [IGA] 0/1 response) at week 16 retained their EASI-75 and IGA 0/1 response, respectively. At week 52, these figures reached 99.0% and 87.0%, respectively. Among those who had not achieved EASI-75 or IGA 0/1 at week 16, 65.4% achieved EASI-75 and 18.1% achieved IGA 0/1 at week 20, and reached 86.8% and 50.0% at week 52, respectively. The patient-reported outcomes also improved sustainedly. <u><b><i>Conclusions:</i></b></u> Long-term stapokibart treatment induced sustained clinical improvements in adult patients with moderate-to-severe AD, regardless of their initial response to 16-week treatments.

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Publication Details

Journal
Dermatitis
Published
2025-03-28
DOI
https://doi.org/10.1089/derm.2024.0533
Primary Topic
Dermatology and Skin Diseases
Type
article
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article

Long-Term Stapokibart Treatment Induces Sustained Clinical Improvements in Patients With Moderate-to-Severe Atopic Dermatitis

Yan Zhao, Qing Sun, Chao Ji, Bin Yang et al.
Dermatitis
Dermatology and Skin Diseases
article

Long-Term Stapokibart Treatment Induces Sustained Clinical Improvements in Patients With Moderate-to-Severe Atopic Dermatitis

Yan Zhao, Qing Sun, Chao Ji, Bin Yang, Qingchun Diao, Xiaohua Tao, Tao Cai, Rong Xiao, Qianjin Lu, Fuqiu Li, Yudian Qiu, Liming Wu, Xiao‐Yong Man, Lihua Wang, Bo Chen, Linfeng Li, Jianzhong Zhang, Yumei Li, Jinyan Wang, Xiaohong Zhu, Jing Sun, Yanyan Feng, Litao Zhang, Hong Ren, Jianyun Lu, Jingyi Li, Huiming Zeng
article en

Abstract

<u><b><i></i></b></u> <u><b><i>Background:</i></b></u> Stapokibart has been approved for the treatment of adults with atopic dermatitis (AD) in China. <u><b><i>Objective:</i></b></u> To report long-term efficacy of stapokibart in patients with moderate-to-severe AD. <u><b><i>Methods:</i></b></u> This post hoc analysis included 237 adult patients from a phase 3 trial (NCT05265923) who received stapokibart 300 mg (loading dose, 600 mg) every 2 weeks during the 16-week double-blind period and continued with the same dose of stapokibart in the subsequent 36-week maintenance period. <u><b><i>Results:</i></b></u> At week 20, 100% and 92.2% of patients who achieved coprimary endpoints (≥75% improvement in Eczema Area and Severity Index [EASI-75] and Investigator's Global Assessment [IGA] 0/1 response) at week 16 retained their EASI-75 and IGA 0/1 response, respectively. At week 52, these figures reached 99.0% and 87.0%, respectively. Among those who had not achieved EASI-75 or IGA 0/1 at week 16, 65.4% achieved EASI-75 and 18.1% achieved IGA 0/1 at week 20, and reached 86.8% and 50.0% at week 52, respectively. The patient-reported outcomes also improved sustainedly. <u><b><i>Conclusions:</i></b></u> Long-term stapokibart treatment induced sustained clinical improvements in adult patients with moderate-to-severe AD, regardless of their initial response to 16-week treatments.

Dermatitis
Jiangnan University (CN), Jiangsu University (CN), Tianjin University of Traditional Chinese Medicine (CN), Fujian Medical University (CN), Central South University (CN), Capital Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Chengdu Medical College (CN), Sichuan University (CN), Westlake University (CN), West China Hospital of Sichuan University (CN), Ningbo No. 2 Hospital (CN), Jinan Central Hospital (CN), Chinese Academy of Medical Sciences Dermatology Hospital (CN), Affiliated Hospital of Jiangsu University (CN), First Affiliated Hospital of Fujian Medical University (CN), Peking University People's Hospital (CN), Wuxi No.2 People's Hospital (CN), The First People’s Hospital of Lianyungang (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), Zhejiang Provincial People's Hospital (CN), Chengdu Second People's Hospital (CN), Second Affiliated Hospital of Jilin University (CN), Beijing Friendship Hospital (CN), Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN), Second Xiangya Hospital of Central South University (CN), Third Xiangya Hospital (CN), Second Affiliated Hospital of Zhejiang University (CN), Qilu Hospital of Shandong University (CN), First People's Hospital of Chongqing (CN), Shandong First Medical University (CN), Southern Medical University (CN), Hainan Medical University (CN), Chongqing Medical University (CN)
Good health and well-being
Openalex Percentile: Top 88%
Dermatology and Skin Diseases
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