ORIGINAL RESEARCH article

Front. Immunol.

Sec. Autoimmune and Autoinflammatory Disorders: Autoinflammatory Disorders

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1644875

Effectiveness and Safety of Dupilumab in the Treatment of Pediatric Atopic Dermatitis: A Real-World Study from China

Provisionally accepted
Yue  XuYue Xu1,2Bowen  LiBowen Li1Wenge  WangWenge Wang2*
  • 1Graduate School, Hebei North University, Zhangjiakou, China
  • 2People's Liberation Army Air Force Special Medical Center, Beijing, China

The final, formatted version of the article will be published soon.

Atopic dermatitis (AD), a common chronic inflammatory skin disorder in children, often shows limited response to conventional therapies with potential adverse effects. This real-world study evaluated dupilumab-a monoclonal antibody targeting IL-4/IL-13 signaling-in 59 Chinese pediatric patients (aged 6 months-12 years) with moderate-to-severe AD, stratified by body weight. Over a median 33week follow-up (up to 96 weeks), we dynamically assessed efficacy metrics including Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index, alongside systematic surveillance of treatmentemergent adverse events (TEAEs). At Week 16, 68.97.0% (40/58) achieved EASI-75, accompanied by significant symptom relief (68.17% itch reduction; 77.4% quality-oflife improvement). Efficacy persisted beyond Week 16 (>58.82% sustained EASI-75) without age or sex differences. TEAEs occurred in 25.42% (15/59) of patients, primarily conjunctivitis (10.17%) and paradoxical eczema flares (5.08%). Notably, we report the first pediatric cases of acute rash exacerbation within 72 hours post-initial dose (3 patients, EASI increase: 39.90%-61.13%) and a unique late-onset pustular dermatitis with fever. These findings confirm dupilumab's sustained effectiveness and manageable safety in Chinese children with AD while highlighting the need for vigilance against early paradoxical flares and rare inflammatory reactions, providing critical real-world evidence for long-term use in this population.

Keywords: Dupilumab, Pediatric atopic dermatitis, Dupilumab-induced paradoxical flare, Dupilumab-associated pustular dermatitis, Real-world study

Received: 11 Jun 2025; Accepted: 30 Jun 2025.

Copyright: © 2025 Xu, Li and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Wenge Wang, People's Liberation Army Air Force Special Medical Center, Beijing, China

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