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

IF 4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-07-12 DOI:10.1007/s12325-025-03284-7

Yan Zhao, Litao Zhang, Liming Wu, Bin Yang, Jinyan Wang, Yumei Li, Qingchun Diao, Jingyi Li, Qing Sun, Xiaohong Zhu, Xiaoyong Man, Lihua Wang, Yanyan Feng, Tao Cai, Huiming Zeng, Linfeng Li, Jianyun Lu, Hong Ren, Fuqiu Li, Qianjin Lu, Xiaohua Tao, Rong Xiao, Chao Ji, Chao Liang, Yanping Qiu, Bo Chen, Jianzhong Zhang

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Abstract

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.

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接受Stapokibart治疗超过52周的中度至重度特应性皮炎成人患者报告的结果：一项3期试验的事后分析

引言：特应性皮炎（AD）严重影响生活质量，需要长期治疗。这项事后分析旨在评估stapokibart（一种抗il - 4r α抗体）对中度至重度AD成人患者报告结局（pro）的影响，该研究来自一项3期试验（NCT05265923）。方法：符合条件的患者按1:1随机分组，每2周（Q2W）接受stapokibart 300 mg（负荷剂量600 mg）（n = 251）或安慰剂（n = 249）治疗，为期16周。随后，两组均给予stapokibart 300 mg Q2W，连续36周，随访8周。分析的主要PROs包括：52周治疗期间皮肤病学生活质量指数（DLQI）和患者导向湿疹测量（POEM）评分较基线的百分比变化、每日峰值瘙痒数值评定量表（PP-NRS）评分≤4和≤1、DLQI评分≤5和POEM评分≤7的周平均缓解率。结果：与安慰剂组相比，stapokibart组患者在第16周达到每周平均每日PP-NRS评分≤4的比例更高（49.8%比24.2%,p）。结论：stapokibart通过52周的治疗显著改善了中重度AD成人患者的pro。试验注册：ClinicalTrials.gov识别码，NCT05265923。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.