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

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