Zhao Yan, Zhang Litao, Wu Liming, Yang Bin, Wang Jinyan, Li Yumei, Li Jingyi, Diao Qingchun, Sun Qing, Zhu Xiaohong, Man Xiaoyong, Wang Lihua, Li Linfeng, Feng Yanyan, Zeng Huiming, Cai Tao, Ren Hong, Lu Jianyun, Lu Qianjin, Tao Xiaohua, Xiao Rong, Ji Chao, Li Fuqiu, Zhang Jianzhong
Department of Dermatology, Peking University People's Hospital, Beijing, China.
Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.
Allergy. 2025 May;80(5):1348-1357. doi: 10.1111/all.16368. Epub 2024 Oct 25.
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.
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.
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-week treatment period, 88.1% of patients reported treatment-emergent adverse events, most were mild or moderate.
Long-term treatment with stapokibart demonstrated a sustained efficacy and favorable safety profile in adults with moderate-to-severe AD.
中重度特应性皮炎（AD）的管理需要长期治疗。司他泊基巴特是一种靶向白细胞介素-4受体α亚基（IL-4Rα）的人源化单克隆抗体，IL-4Rα是AD关键致病驱动因子IL-4和IL-13的共同受体。在一项关键的3期试验（NCT05265923）中，接受司他泊基巴特治疗的成年AD患者中，达到湿疹面积和严重程度指数（EASI-75；66.9%对25.8%）自基线改善≥75%以及在第16周时研究者整体评估（IGA）评分为0/1且降低≥2分（44.2%对16.1%）的比例显著高于接受安慰剂治疗的患者。在此，我们报告该试验中司他泊基巴特的长期（52周）疗效和安全性。
在完成16周双盲治疗后，司他泊基巴特组和安慰剂组的患者均进入为期36周的维持治疗期，每2周接受300mg司他泊基巴特治疗。在整个维持期允许联合使用治疗AD的局部用药。
进入维持期的476例患者中，430例完成了治疗。在第52周时，继续使用司他泊基巴特的患者和从安慰剂转换为司他泊基巴特的患者中分别有92.5%和88.7%达到EASI-75；分别有67.3%和64.2%的患者IGA评分为0或1且降低≥2分；分别有67.3%和60.5%的患者每日峰值瘙痒数字评定量表（PP-NRS）每周平均值降低≥4分。在52周的治疗期内，88.1%的患者报告了治疗期间出现的不良事件，大多数为轻度或中度。
司他泊基巴特的长期治疗在中重度AD成人患者中显示出持续的疗效和良好的安全性。
