Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open‐Label, Phase II Study

Abstract

BackgroundPeanut allergy is a potentially life‐threatening food allergy in children. This study explored whether dupilumab, a human monoclonal immunoglobulin (Ig)G4 antibody that blocks the activity of interleukin (IL)‐4/IL‐13, improved safety and desensitization to peanut exposure in children with peanut allergy.MethodsA Phase II, 24‐week, multicenter, single‐arm, open‐label, proof‐of‐concept study was conducted in the USA and Canada (NCT03793608). Children/adolescents with peanut allergy received subcutaneous dupilumab 300 mg (≥ 60 kg) or 200 mg (≥ 20 to < 60 kg) every 2 weeks. The primary endpoint was the proportion of participants who passed a double‐blind placebo‐controlled food challenge (DBPCFC) with ≥ 444 mg (cumulative) of peanut protein at week 24. Secondary endpoints included safety measures (Consortium of Food Allergy Research grading system) and change from baseline in peanut‐specific (ps)‐IgG4, total IgE, and ps‐IgE.ResultsTwenty‐four participants enrolled and received dupilumab: 75.0% were male, 79.2% were white, mean (standard deviation) age was 11.7 (3.3) years. Most (95.8%) participants had not received allergen immunotherapy. Two participants (8.3%) achieved the primary endpoint and passed the DBPCFC at week 24. Fifteen participants (62.5%) reported 66 treatment‐emergent adverse events, all being mild or in moderate intensity. At the week 24 DBPCFC, 8 participants (33.3%) had a grade 2 allergic reaction (no grade 3 or above); 10 (41.7%) used adrenaline as a rescue medication. Dupilumab treatment resulted in a median reduction of total and ps‐IgE of −54% and −49%, respectively, and a 0% change in ps‐IgG4.ConclusionsDupilumab monotherapy treatment for 24 weeks did not improve desensitization to peanut exposure after food challenge.