Infections in Children Aged 6 Months to 5 Years Treated With Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis

Amy S. Paller, Elaine C. Siegfried, Michael J. Cork, Peter D. Arkwright, Lawrence F. Eichenfield, Michele Ramien, Faisal A. Khokhar, Zhen Chen, Annie Zhang, Sonya Cyr

Research output: Contribution to journalArticlepeer-review

Abstract

Background
Patients with atopic dermatitis (AD), particularly infants and young children, are at
greater risk of developing skin infections. In this study we assessed infection rates in AD patients aged 6 months to 5 years treated with dupilumab.

Methods
In LIBERTY AD PRESCHOOL, a double-blind, placebo-controlled, phase 3 clinical
trial, children aged 6 months to 5 years with moderate-to-severe AD were randomized 1:1 to subcutaneous dupilumab or placebo, with concomitant low-potency topical corticosteroids, every 4 weeks for 16 weeks. Exposure-adjusted infection rates were used to compare treatment groups.

Results
The analysis included 162 patients, of whom 83 received dupilumab and 79 received placebo. Overall infection rates were not significantly different between the dupilumab and placebo groups (rate ratio [RR] 0.75, 95% CI [0.48-1.19], P = 0.223). Non-herpetic adjudicated skin infections and bacterial infections were significantly less frequent with dupilumab vs placebo (non-herpetic skin infections: RR 0.46, 95% CI [0.21-0.99], P = 0.047; bacterial infections: RR 0.09, 95% CI [0.01-0.67], P = 0.019), and the number of patients using systemic anti-infective medication was significantly lower in the dupilumab group (RR 0.52, 95% CI [0.30-0.89], P = 0.019). There were no significant differences in the number of herpetic infections between the dupilumab and placebo groups (RR 1.17, 95% CI [0.31-4.35], P = 0.817). The number of patients with two or more infection events was significantly higher in the placebo group (RR 0.29, 95% CI [0.12-0.68], P = 0.004), and no severe or serious infections (including eczema herpeticum) were observed among patients receiving dupilumab.

Conclusions
These data suggest that dupilumab treatment in infants and children younger than 6 years with AD does not increase overall risk of infections and is associated with a reduced risk of bacterial and non-herpetic skin infections compared to placebo, resulting in a reduced need for anti-infective medication.
Original languageEnglish
Pages (from-to)163–173
JournalPediatric Drugs
Volume26
Early online date24 Jan 2024
DOIs
Publication statusPublished - 1 Mar 2024

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