BackgroundManagement 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.MethodsAfter 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.ResultsOf 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.ConclusionLong‐term treatment with stapokibart demonstrated a sustained efficacy and favorable safety profile in adults with moderate‐to‐severe AD.

中文翻译：

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stapokibart 治疗中度至重度特应性皮炎的长期疗效和安全性：3 期试验的 52 周结果


背景中度至重度特应性皮炎 （AD） 的管理需要长期治疗。Stapokibart 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 IL-4 和 IL-13 的共享受体，它们是 AD 的关键致病驱动因素。在一项关键的 3 期试验 （NCT05265923） 中，接受 stapokibart 的成年 AD 患者比例显著高于≥安慰剂，湿疹面积和严重程度指数 （EASI-75;66.9% vs. 25.8%） 和研究者整体评估 （IGA） 评分为 0/1，降低 ≥2 分（44.2% vs. 16.1%）。在此，我们报告了该试验中 stapokibart 的长期 （52 周） 疗效和安全性。方法完成 16 周双盲治疗后，stapokibart 组和安慰剂组患者均进入 36 周维持治疗期，每 2 周接受 stapokibart 300 mg。在整个维持期间允许同时使用局部药物治疗 AD。结果476 例进入维持期的患者中，430 例完成了治疗。在第 52 周时，92.5% 的持续 stapokibart 患者和 88.7% 的患者分别达到 EASI-75;IGA 评分为 0 或 1，分别有 67.3% 和 64.2% 的患者降低 ≥2 分;67.3% 和 60.5% 的患者每日峰值瘙痒数字评定量表 （PP-NRS） 的每周平均值分别降低了 ≥4 分。在 52 周的治疗期间，88.1% 的患者报告了治疗中出现的不良事件，大多数是轻度或中度。结论stapokibart 长期治疗在成人中度至重度 AD 患者中显示出持续的疗效和良好的安全性。