The Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of moderate to severe atopic dermatitis in pediatric patients aged 6 months to 5 years whose disease is not adequately controlled with topical therapies or when those therapies are not advisable.
The approval was based on data from the phase 3 LIBERTY AD PRESCHOOL study (ClinicalTrials.gov Identifier: NCT03346434), which evaluated the safety and efficacy of Dupixent added to low potency topical corticosteroids (TCS) vs low potency TCS alone in 162 children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. In the study, patients received Dupixent 200mg (weight ≥5 to <15kg) or 300mg (weight ≥15 to <30kg) subcutaneously every 4 weeks.
Results showed that 28% of patients treated with Dupixent achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) compared with 4% of the placebo group (primary endpoint; treatment difference, 24% [13-34]). Moreover, 53% of Dupixent-treated patients experienced at least a 75% improvement from baseline on the Eczema Area and Severity Index (coprimary endpoint outside of the United States) vs 11% of placebo patients.
Additionally, 48% of patients on Dupixent achieved a clinically meaningful reduction in itch, (defined as at least a 4-point improvement in the Worst Scratch/Itch numerical rating scale) vs 9% of placebo patients.
The safety profile of Dupixent in children aged 6 months to 5 years was similar to that observed in atopic dermatitis trials involving patients 6 years of age and older. Long-term safety was assessed in a 52-week open-label extension study of 180 pediatric patients 6 months to 5 years of age; findings showed a consistent safety profile with that observed in older patients.
“Until today, treatment options in the US for infants and children under the age of 6 suffering from moderate to severe atopic dermatitis have been limited to topical steroids, which may be associated with significant safety risks when used long-term,” said Naimish Patel, MD, Senior Vice President, Head of Global Development, Immunology and Inflammation at Sanofi. “This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease.”
Dupixent, an interleukin-4 receptor alpha antagonist, is already indicated for the treatment of moderate to severe atopic dermatitis in patients 6 years of age and older; for maintenance treatment of severe asthma in patients 12 years of age and older; for chronic rhinosinusitis with nasal polyps in patients 18 years of age and older; and for the treatment of eosinophilic esophagitis in patients 12 years of age and older weighing at least 40kg.
- FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. News release. Regeneron Pharmaceuticals, Inc. Accessed June 7, 2022. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-first-biologic-medicine-0
- Dupixent. Package insert. Regeneron Pharmaceuticals, Inc.; 2022. Accessed June 7, 2022. https://www.regeneron.com/downloads/dupixent_fpi.pdf