Safety and Efficacy of Treatment with Dupilumab for up to 2 Years in Infants and Young Children with Atopic Dermatitis - PubMed

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Dupilumab treatment for up to 2 years in infants and young children (6 months to 5 years) with moderate-to-severe atopic dermatitis (AD) demonstrated sustained efficacy, with 92.1% achieving a 75% reduction in Eczema Area and Severity Index (EASI-75) and a mean 49.0% reduction in affected body surface area by week 104.
The safety profile was consistent with prior studies, with 87.8% experiencing treatment-emergent adverse events (TEAEs), mostly mild to moderate; only one serious drug-related TEAE (pinworm infection) occurred without treatment discontinuation, and one non-serious drug-related severe urticaria led to discontinuation.
This open-label extension study (LIBERTY AD PED OLE) supports long-term continuous use of weight-tiered dupilumab dosing (200 mg or 300 mg every 4 weeks) in pediatric patients, with improvements in quality of life and no new safety concerns identified over the 2-year period.

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