使用Stapokibart治疗52周的中度至重度特应性皮炎成人患者的患者报告结局：一项3期试验的事后分析
Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial.
作者信息
Zhao Yan, Zhang Litao, Wu Liming, Yang Bin, Wang Jinyan, Li Yumei, Diao Qingchun, Li Jingyi, Sun Qing, Zhu Xiaohong, Man Xiaoyong, Wang Lihua, Feng Yanyan, Cai Tao, Zeng Huiming, Li Linfeng, Lu Jianyun, Ren Hong, Li Fuqiu, Lu Qianjin, Tao Xiaohua, Xiao Rong, Ji Chao, Liang Chao, Qiu Yanping, Chen Bo, Zhang Jianzhong
机构信息
Department of Dermatology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.
出版信息
Adv Ther. 2025 Jul 12. doi: 10.1007/s12325-025-03284-7.
INTRODUCTION
Atopic dermatitis (AD) significantly impairs quality of life and requires long-term management. This post hoc analysis aimed to evaluate the effect of stapokibart (an anti-IL-4Rα antibody) on patient-reported outcomes (PROs) in adults with moderate-to-severe AD from a phase 3 trial (NCT05265923).
METHODS
Eligible patients were randomized 1:1 to receive stapokibart 300 mg (loading dose 600 mg) (n = 251) or placebo (n = 249) every 2 weeks (Q2W) for 16 weeks. Subsequently, both groups received stapokibart 300 mg Q2W for 36 weeks and were followed-up for 8 weeks. Main PROs analyzed included percentage change from baseline in the Dermatology Life Quality Index (DLQI) and the Patient-Oriented Eczema Measure (POEM) scores, response rates of weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) score ≤ 4 and ≤ 1, DLQI score ≤ 5, and POEM score ≤ 7 over 52-week treatment.
RESULTS
A higher proportion of patients in the stapokibart group achieved weekly average of daily PP-NRS score ≤ 4 compared with the placebo-stapokibart group at week 16 (49.8% vs. 24.2%, p < 0.0001); the proportion at week 52 increased to 84.9% and 80.9%, respectively. Weekly average of daily PP-NRS score ≤ 1 was achieved in 35.2% and 32.1% of patients in stapokibart and placebo-stapokibart groups, respectively, at week 52. The stapokibart group had greater improvements in DLQI and POEM scores compared with the placebo-stapokibart group over weeks 4-16, and the improvements continued during maintenance period in both groups. The proportion of patients achieving DLQI score ≤ 5 was 46.2% versus 28.8% at week 16 (p < 0.0001) and 68.7% versus 73.6% at week 52 in the stapokibart versus placebo-stapokibart groups. POEM score ≤ 7 was achieved in 45.8% versus 22.5% of patients at week 16 (p < 0.0001) and 67.8% versus 62.7% at week 52.
CONCLUSION
Stapokibart significantly improved PROs in adults with moderate-to-severe AD through 52-week treatment.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT05265923.
引言
特应性皮炎（AD）严重影响生活质量，需要长期管理。这项事后分析旨在评估司他泊单抗（一种抗IL-4Rα抗体）对一项3期试验（NCT05265923）中中度至重度AD成人患者报告结局（PROs）的影响。
方法
符合条件的患者按1:1随机分组，每2周（Q2W）接受一次司他泊单抗300mg（负荷剂量600mg）（n = 251）或安慰剂（n = 249），共16周。随后，两组均每2周接受一次司他泊单抗300mg，持续36周，并随访8周。分析的主要PROs包括皮肤科生活质量指数（DLQI）和患者导向性湿疹评估（POEM）评分相对于基线的变化百分比、在52周治疗期间每日峰值瘙痒数字评定量表（PP-NRS）评分≤4和≤1、DLQI评分≤5以及POEM评分≤7的每周平均反应率。
结果
在第16周时，司他泊单抗组达到每日PP-NRS评分≤4的每周平均患者比例高于安慰剂-司他泊单抗组（49.8%对24.2%，p < 0.0001）；在第52周时，该比例分别增至84.9%和80.9%。在第52周时，司他泊单抗组和安慰剂-司他泊单抗组分别有35.2%和32.1%的患者达到每日PP-NRS评分≤1。在第4至16周期间，司他泊单抗组在DLQI和POEM评分方面的改善大于安慰剂-司他泊单抗组，且在两组的维持期改善仍持续。在第16周时，司他泊单抗组和安慰剂-司他泊单抗组达到DLQI评分≤5的患者比例分别为46.2%对28.8%（p < 0.0001），在第52周时分别为68.7%对73.6%。在第16周时，达到POEM评分≤7的患者比例分别为45.8%对22.5%（p < 0.0001），在第52周时分别为67.8%对62.7%。
结论
通过52周的治疗，司他泊单抗显著改善了中度至重度AD成人患者的PROs。
试验注册
ClinicalTrials.gov标识符，NCT05265923。
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