Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China

BackgroundAtopic dermatitis (AD), a common chronic inflammatory skin disorder in children, often shows limited response to conventional therapies with potential adverse effects.MethodsThis real-world study evaluated dupilumab—a monoclonal antibody targeting IL-4/IL-13 signaling—in 59 Chinese pediatr...

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Main Authors: Yue Xu, Bowen Li, Wenge Wang
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Immunology
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Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2025.1644875/full
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author Yue Xu
Yue Xu
Bowen Li
Wenge Wang
author_facet Yue Xu
Yue Xu
Bowen Li
Wenge Wang
author_sort Yue Xu
collection DOAJ
description BackgroundAtopic dermatitis (AD), a common chronic inflammatory skin disorder in children, often shows limited response to conventional therapies with potential adverse effects.MethodsThis 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 33-week 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 treatment-emergent adverse events (TEAEs).ResultsAt Week 16, 68.97% (40/58) achieved EASI-75, accompanied by significant symptom relief (68.17% itch reduction; 77.4% quality-of-life 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.ConclusionThese 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.
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spelling doaj-art-8caac70b9a614ff1a312bbc671ee92522025-08-20T02:39:45ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-07-011610.3389/fimmu.2025.16448751644875Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from ChinaYue Xu0Yue Xu1Bowen Li2Wenge Wang3Graduate School of Hebei North University, Zhangjiakou, Hebei, ChinaPediatric Department, Air Force Medical Center, PLA, Beijing, ChinaGraduate School of Hebei North University, Zhangjiakou, Hebei, ChinaPediatric Department, Air Force Medical Center, PLA, Beijing, ChinaBackgroundAtopic dermatitis (AD), a common chronic inflammatory skin disorder in children, often shows limited response to conventional therapies with potential adverse effects.MethodsThis 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 33-week 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 treatment-emergent adverse events (TEAEs).ResultsAt Week 16, 68.97% (40/58) achieved EASI-75, accompanied by significant symptom relief (68.17% itch reduction; 77.4% quality-of-life 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.ConclusionThese 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.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1644875/fulldupilumabpediatric atopic dermatitisdupilumab-induced paradoxical flaredupilumab-associated pustular dermatitisreal-world study
spellingShingle Yue Xu
Yue Xu
Bowen Li
Wenge Wang
Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
Frontiers in Immunology
dupilumab
pediatric atopic dermatitis
dupilumab-induced paradoxical flare
dupilumab-associated pustular dermatitis
real-world study
title Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
title_full Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
title_fullStr Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
title_full_unstemmed Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
title_short Effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis: a real-world study from China
title_sort effectiveness and safety of dupilumab in the treatment of pediatric atopic dermatitis a real world study from china
topic dupilumab
pediatric atopic dermatitis
dupilumab-induced paradoxical flare
dupilumab-associated pustular dermatitis
real-world study
url https://www.frontiersin.org/articles/10.3389/fimmu.2025.1644875/full
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