Article
Author: Zhu, Xiaohong ; Chu, Wei ; Lu, Qianjin ; Diao, Qingchun ; Ren, Hong ; Tao, Xiaohua ; Li, Yumei ; Yan, Hongyue ; Zhang, Litao ; Zhao, Wenjie ; Li, Jingyi ; Ji, Chao ; Yang, Bin ; Cai, Tao ; Wang, Jinyan ; Cheng, Hao ; Zhao, Yan ; Xiao, Rong ; Zhang, Chunlei ; Wang, Lihua ; Zeng, Huiming ; Zhang, Furen ; Man, Xiaoyong ; Chen, Bo ; Li, Fuqiu ; Li, Linfeng ; Ding, Yangfeng ; Zhang, Jianzhong ; Wu, Liming ; Lu, Jianyun ; Sun, Qing ; Feng, Yanyan ; Xia, Xiujuan ; Qiu, Yanping
BACKGROUND:Eosinophils are involved in the pathogenesis of atopic dermatitis (AD).
OBJECTIVE:This post-hoc analysis evaluated the effect of stapokibart on blood eosinophil counts in moderate-to-severe AD patients.
METHODS:The phase II AD002 trial (n = 120) randomly assigned patients to stapokibart 300 mg every 2 weeks (Q2W), 150 mg Q2W, or placebo for 16 weeks. The phase III AD005 trial (n = 500) randomly assigned patients to stapokibart 300 mg Q2W or placebo for 16 weeks, followed by open-label stapokibart 300 mg Q2W for 36 weeks. Efficacy and safety were analyzed in subgroups stratified by baseline blood eosinophil counts (≥500 or <500 cells/µL).
RESULTS:Stapokibart treatment resulted in sustained reductions in blood eosinophil counts versus placebo (baseline vs. Week 16: high-dose 420 vs. 235 cells/μL, low-dose 530 vs. 315 cells/μL in AD002; 370 vs. 210 cells/μL in AD005). Furthermore, stapokibart demonstrated superior efficacy over placebo in achieving higher Eczema Area and Severity Index (EASI)-75 response rates at Week 16 in both eosinophil subgroups. The incidence of adverse events was similar across eosinophil subgroups, with most events being mild or moderate.
CONCLUSION:Stapokibart reduced blood eosinophil counts in AD patients and demonstrated favorable efficacy and safety regardless of baseline blood eosinophil counts.