Efficacy and Safety of Extending Dosing Interval of Stapokibart in Patients with Atopic Dermatitis

作者：Yan Zhao, Cheng Zhou, Xiao‐Yong Man, Bing Liu, Songmei Geng, Yunsheng Liang, Ying Li, Siping Zhang, Yang Shuxia, Huichun Su, Hengguang Zhao, Xiang Nong, Ying Gao, Wenzhong Wu, Chunxing Xu, Liangchun Wang, Qi Wang, Lunfei Liu, Xiaohong Zhu, Qiuhe Song, Juan Su, Lixia Zhang, Jianyun Lu, Guohong Hu, Hongyi Li, Yuanyuan Shang, Fulun Li, Yifei Wang, Lixiong Gu, Hui Chen, Huiping Wang, Ningning Dang, Cheng Fang, Bo Chen, Yudian Qiu, Chao Liang, Jianzhong Zhang · 发表于：Dermatitis · 年份：2025 · DOI：10.1177/17103568251361896 · 被引用次数：4 · 研究领域：Dermatology and Skin Diseases、Allergic Rhinitis and Sensitization、Asthma and respiratory diseases

Abstract: Background: Stapokibart is a novel anti-interleukin-4 receptor α subunit monoclonal antibody approved for moderate-to-severe atopic dermatitis (AD) in adults. Objective: To evaluate the feasibility of extending dosing interval of stapokibart based on efficacy response in AD. Methods: In this ongoing, multicenter, open-label, single-arm trial (NCT06116565), stapokibart 300 mg was administered subcutaneously every 2 weeks (Q2W) for 12 weeks, followed by dosing interval adjustments at weeks 12 and 36. At week 12, nonresponders (failed to achieve ≥50% improvement from baseline in Eczema Area and Severity Index [EASI-50]) were withdrawn, fast responders (achieved ≥75% improvement from baseline in EASI score [EASI-75] or Investigator’s Global Assessment score of 0/1 [IGA 0/1]) were extended to every 4 weeks (Q4W), and slow responders (achieved EASI-50 but not EASI-75 or IGA 0/1) continued Q2W dosing. At week 36, fast responders achieving ≥90% improvement from baseline in EASI score (EASI-90) or IGA 0/1 were further extended to every 8 weeks (Q8W) (Q2W-Q4W-Q8W group), slow responders with EASI-90 or IGA 0/1 were extended to Q4W (Q2W-Q2W-Q4W group), and others maintained their prior dosing through week 52 (Q2W-Q4W-Q4W and Q2W-Q2W-Q2W groups). Results: As of April 7, 2025, 256 and 200 patients completed 12 and 36 weeks of treatment, respectively. In the Q2W-Q4W-Q8W group, 93.0%, 73.7%, and 70.7% of patients sustained EASI-75, IGA 0/1, and ≥4-point reduction in weekly average...