ArticleJournal of the European Academy of Dermatology and Venereology : JEADV2026
Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis.
Article in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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- Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
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10 authors.
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Abstract
backgroundDupilumab, a human monoclonal anti-interleukin-4/13 antibody, is approved for treating severe atopic dermatitis (AD) in children aged 6 months-5 years. It received approval for an Early Access Program (EAP) for children by the French Health Authority in October 2022.
objectivesThis EAP aims to evaluate the effectiveness and safety of dupilumab in children (aged 6 months-5 years) with severe AD requiring systemic treatment.
methodsCumulative data from the French EAP were analysed. Children with severe AD were administered dupilumab 200 and 300 mg (children ≥5 to <15 kg and ≥15 to <30 kg, respectively) every 4 weeks via a pre-filled syringe. The Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) 50/75/90, Pruritus-Numerical Rating Scale (P-NRS), Infants' Dermatitis Quality of Life Index (IDQOL; for children aged <4 years) and Children's Dermatology Life Quality Index (CDLQI; for children aged ≥4 years) scores were assessed at baseline and follow-up months (M) 1, 3 and 6. Safety was evaluated.
resultsA total of 198 children were enrolled (<2 years old: N = 27 [13.6%]; ≥2 years old: N = 171 [86.4%]). Of the 116 evaluated patients (exposed patients with at least ≥1 follow-up form), 83.7% achieved an IGA score of 0/1, 94.4%/75.0%/44.4% achieved an EASI 50/75/90, respectively, and 67.6% achieved a ≥4-point improvement in the P-NRS scores, at M6. The mean ± SD reduction from treatment initiation to M6 in the IGA, EASI and P-NRS scores was -2.1 ± 1.2, -17.5 ± 11.6 and -4.4 ± 2.8, respectively. The mean ± SD IDQOL and CDLQI scores reduced numerically from treatment initiation to M6 by -6.9 ± 6.6 and -8.8 ± 7.3, respectively. Safety was consistent with the established safety profile of dupilumab.
conclusionsThe effectiveness and safety profile of dupilumab in children (aged 6 months-5 years) with severe AD were consistent with those reported in children with moderate-to-severe AD in clinical studies.
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