Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy

To investigate whether dupilumab improves the efficacy of peanut oral immunotherapy (OIT) in pediatric patients.The study included 148 patients aged 6 to 17 years with confirmed peanut allergy who experienced dose-limiting symptoms at or before the challenge dose of peanut protein during a screening double-blind, placebo-controlled food challenge (DBPCFC) and had no symptoms with placebo.This was a double-blind, randomized controlled trial. Eligible patients were randomized 2:1 into 2 groups: dupilumab + OIT and placebo + OIT for the 24- to 36-week up-dosing phase. Patients in the treatment group were then rerandomized 1:1 to receive either dupilumab + OIT or placebo + OIT during a 24-week maintenance phase. Following maintenance, all patients underwent a peanut protein DBPCFC. Those who passed the food challenge completed a higher-dose challenge at a 12-week post-treatment follow-up.Adjunctive therapy with dupilumab increased the rate of passing a food challenge after the up-dosing phase by 20.2% compared with placebo. Patients who continued dupilumab during the maintenance phase had a higher rate of passing the DBPCFC than those in the continuous placebo or dupilumab-to-placebo switch groups. Biomarkers, including total immunoglobulin E (IgE) and OIT-induced peanut-specific IgE, were reduced in the dupilumab group. OIT-related symptoms were lower in the dupilumab group during the up-dosing phase.Dupilumab is a safe, well-tolerated medication that, when used as an adjunct to peanut OIT, improves desensitization and increases the proportion of patients who successfully pass a peanut food challenge.Peanut allergy affects millions of children and can be life-threatening. The Food and Drug Administration recently approved OIT for peanuts, offering a promising treatment through gradual exposure to increasing doses of peanut protein. However, OIT carries risks—from mild allergic reactions to anaphylaxis—particularly during the initial dose escalation and up-dosing phase. This study demonstrates that adding dupilumab enhances both the efficacy and safety of peanut OIT, helping address common concerns patients and caregivers may have. It also opens the door for broader use of biologics to support food allergy treatment, not just symptom management.