Therapy Lowers Infection Rates in Children, Adolescents With Atopic Dermatitis
February 28, 2022
Treatment with dupilumab did not increase overall infection risk in children and adolescents with atopic dermatitis and was associated with lower skin infection rates compared with placebo, according to findings published in Pediatric Dermatology.
"Patients with moderate-to-severe atopic dermatitis have increased risk of cutaneous and extracutaneous infections," researchers wrote in the study background. "Dupilumab has previously been associated with reduced risk of serious/severe infections and non-herpetic skin infections in adults with moderate-to-severe atopic dermatitis."
To assess infection rates in pediatric patients with atopic dermatitis, researchers conducted a pooled analysis of data from two phase 3 clinical trials. One trial randomized adolescents between the ages of 12 and 17 with moderate-to-severe atopic dermatitis to treatment with dupilumab monotherapy or placebo. The other randomized children between ages 6 and 11 with severe atopic dermatitis to dupilumab with concomitant topical corticosteroids or placebo.
A total 612 children and adolescents were included in the pooled analysis, 407 of whom received dupilumab. Among them, 261 received dupilumab at approved doses and 146 received other studied doses of dupilumab.
The analysis found numerically lower overall infection rates with dupilumab versus placebo. Exposure-adjusted rates, measured as patients with at least one infection per 100 patient-years, were 227 with placebo, 173 with dupilumab at approved doses, 206 with dupilumab at other doses, and 184 with all dupilumab doses, researchers reported.
Total skin infections, too, were numerically lower with dupilumab. Exposure-adjusted rates, reflecting patients with at least one skin infection per 100 patient-years, were 67 with placebo, 30 with dupilumab at approved doses, 46 with dupilumab at other doses, and 36 with all dupilumab doses, the study found.
Paller AS, Beck LA, Blauvelt A, et al. Infections in children and adolescents treated with dupilumab in pediatric clinical trials for atopic dermatitis-a pooled analysis of trial data. Pediatr Dermatol. Published online January 26, 2022. doi:10.1111/pde.14909