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

Abstract

BackgroundPeanut allergy is a common, life‐threatening food allergy in children. We evaluated whether dupilumab, which blocks the activity of interleukin (IL)‐4/IL‐13, enhances the efficacy of oral immunotherapy (OIT) AR101 in pediatric patients with peanut allergy.MethodsA Phase II, multicenter, randomized, double‐blind study was conducted in the USA (NCT03682770) in pediatric patients (6–≤ 17 years old) with confirmed peanut allergy. Patients were randomized 2:1 to receive dupilumab + OIT or placebo + OIT during a 28–40‐week up‐dosing period. Patients in the dupilumab + OIT group were re‐randomized 1:1 and received dupilumab + OIT or placebo + OIT during 24‐week OIT maintenance, undergoing a 2044 mg (cumulative) of peanut protein double‐blind, placebo‐controlled food challenge (DBPCFC) following up‐dosing, maintenance, and at 12‐week post‐treatment follow‐up.ResultsThe study enrolled 148 patients, 123 of whom were included in the modified full analysis set, with a mean age of 11.1 years. Dupilumab + OIT treatment (n = 84) led to a 20.2% increase (p < 0.05) in the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein following the up‐dosing period versus placebo (OIT alone, n = 39). Following the OIT maintenance period, continuous dupilumab treatment improved the number of patients who passed a DBPCFC to 2044 mg (cumulative) of peanut protein versus patients continuously on OIT alone (16.6% difference [95% CI −9.7, 42.8], p = 0.2123). Safety was consistent with known dupilumab safety profile.ConclusionsDupilumab provided a modest increase efficacy of OIT in children and adolescents with peanut allergy, though it did not provide protection against OIT‐related anaphylaxis.Trial RegistrationClinicalTrials.gov identifier: NCT03793608