Dupilumab Effective and Safe for Severe Atopic Dermatitis in Infants and Young Children: Study

A new study published in the Journal of the European Academy of Dermatology & Venerology showed that in children with severe atopic dermatitis (AD) between the ages of 6 months and 5 years, dupilumab demonstrated notable effectiveness and a favorable safety profile, which is in line with results previously documented in older pediatric and adult populations.

A human monoclonal anti-interleukin-4/13 antibody called dupilumab is authorized for the treatment of severe atopic dermatitis in children. In October 2022, the French Health Authority approved it for an Early Access Program (EAP) for youngsters. This EAP assessed the safety and efficacy of dupilumab in children (6 months to 5 years old) with severe AD who need systemic therapy.

Analysis was done using cumulative data from the French EAP. Every 4 weeks, children with severe AD were given dupilumab 200 and 300 mg using a pre-filled syringe (children weighing ≥5 to <15 kg and ≥15 to <30 kg, respectively). At baseline and follow-up months (M) 1, 3, and 6, 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 under 4 years), and Children's Dermatology Life Quality Index (CDLQI; for children over 4 years. Safety was assessed.

A total of 198 children (<2 years old: N = 27 [13.6%]; ≥2 years old: N = 171 [86.4%]) were enrolled. 83.7% of the 116 assessed patients (exposed patients with at least one follow-up form) had an IGA score of 0/1, 94.4%/75.0%/44.4% had an EASI score of 50/75/90, and 67.6% had a P-NRS score improvement of at least 4 points, at M6.

The IGA, EASI, and P-NRS scores decreased by an average of −2.1 ± 1.2, −17.5 ± 11.6, and −4.4 ± 2.8, respectively, from the start of therapy to M6. From the start of therapy to M6, the mean ± SD IDQOL and CDLQI scores decreased numerically by −6.9 ± 6.6 and −8.8 ± 7.3, respectively. Safety was in line with dupilumab's recognized safety profile. Overall, the EAP's 6-month follow-up outcomes were in line with those seen in dupilumab randomized clinical trials including children with moderate-to-severe AD between the ages of 6 months and 5 years.

Source:

Lasek, A., Bellon, N., Mallet, S., Aubert, H., Vera, C., Achour, L., Thénié, C., Prescilla, R., Abasq-Thomas, C., & Barbarot, S. (2025). Dupilumab treatment in children aged 6 months to 5 years with severe atopic dermatitis. Journal of the European Academy of Dermatology and Venereology, jdv.70268. https://doi.org/10.1111/jdv.70268