Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).
Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.
Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.
Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.
Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source