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Introduction <p>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).</p> Methods <p>Eligible patients were randomized 1:1 to receive stapokibart 300&#xa0;mg (loading dose 600&#xa0;mg) (<i>n</i>&#xa0;=&#xa0;251) or placebo (<i>n</i>&#xa0;=&#xa0;249) every 2&#xa0;weeks (Q2W) for 16&#xa0;weeks. Subsequently, both groups received stapokibart 300&#xa0;mg Q2W for 36&#xa0;weeks and were followed-up for 8&#xa0;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&#xa0;≤&#xa0;4 and&#xa0;≤&#xa0;1, DLQI score&#xa0;≤&#xa0;5, and POEM score&#xa0;≤&#xa0;7 over 52-week treatment.</p> Results <p>A higher proportion of patients in the stapokibart group achieved weekly average of daily PP-NRS score&#xa0;≤&#xa0;4 compared with the placebo-stapokibart group at week 16 (49.8% vs. 24.2%, <i>p</i>&#xa0;&lt;&#xa0;0.0001); the proportion at week 52 increased to 84.9% and 80.9%, respectively. Weekly average of daily PP-NRS score&#xa0;≤&#xa0;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&#xa0;≤&#xa0;5 was 46.2% versus 28.8% at week 16 (<i>p</i>&#xa0;&lt;&#xa0;0.0001) and 68.7% versus 73.6% at week 52 in the stapokibart versus placebo-stapokibart groups. POEM score&#xa0;≤&#xa0;7 was achieved in 45.8% versus 22.5% of patients at week 16 (<i>p</i>&#xa0;&lt;&#xa0;0.0001) and 67.8% versus 62.7% at week 52.</p> Conclusion <p>Stapokibart significantly improved PROs in adults with moderate-to-severe AD through 52-week treatment.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT05265923.</p>

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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

  • 期刊论文

  • 发表日期：

    2025年7月12日

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  • 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

摘要

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.