Long‐term efficacy and safety of stapokibart for moderate‐to‐severe atopic dermatitis: 52‐week results from a phase 3 trial

作者：Yan Zhao, Litao Zhang, Liming Wu, Bin Yang, Jinyan Wang, Yumei Li, Jingyi Li, Qingchun Diao, Qing Sun, Xiaohong Zhu, Xiao‐Yong Man, Lihua Wang, Linfeng Li, Yanyan Feng, Huiming Zeng, Tao Cai, Hong Ren, Jianyun Lu, Qianjin Lu, Xiaohua Tao, Rong Xiao, Chao Ji, Fuqiu Li, Jianzhong Zhang · 发表于：Allergy · 年份：2024 · DOI：10.1111/all.16368 · 被引用次数：30 · 研究领域：Dermatology and Skin Diseases、Asthma and respiratory diseases、Allergic Rhinitis and Sensitization

BACKGROUND: Management of moderate-to-severe atopic dermatitis (AD) needs long-term therapy. Stapokibart is a humanized monoclonal antibody targeting interleukin-4 receptor α subunit (IL-4Rα), a shared receptor for IL-4 and IL-13 which are key pathogenic drivers of AD. In a pivotal phase 3 trial (NCT05265923), significant higher proportions of adult AD patients receiving stapokibart than placebo achieved ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75; 66.9% vs. 25.8%) and Investigator's Global Assessment (IGA) score of 0/1 with ≥2-point reduction (44.2% vs. 16.1%) at Week 16. Herein, we report long-term (52 weeks) efficacy and safety of stapokibart from this trial. METHODS: After 16-week double-blind treatment completed, patients in both stapokibart and placebo groups entered a 36-week maintenance treatment period and received stapokibart 300 mg every 2 weeks. Concomitant use of topical medications for AD was permitted throughout the maintenance period. RESULTS: Of 476 patients entering maintenance period, 430 completed the treatment. At Week 52, EASI-75 was achieved in 92.5% of patients continuing stapokibart and 88.7% of those switching from placebo to stapokibart, respectively; an IGA score of 0 or 1 with a ≥2-point reduction was achieved in 67.3% and 64.2% of patients, respectively; a ≥4-point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) was achieved in 67.3% and 60.5% of patients, respectively. Over the 52-...