Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities

Abstract

Background: There is a high prevalence rate of atopic comorbidities, including atopic dermatitis (AD), asthma, and concomitant food allergy (CFA), in children with peanut allergy.

Objective: To evaluate whether concomitant atopic comorbidities affect the safety and efficacy of VIASKIN peanut patch (patch containing 250 µg peanut protein [VP250]).

Methods: EPITOPE was a phase 3, double-blind, placebo-controlled trial designed to assess treatment response to VP250, as measured by eliciting dose at 12 months, in children with peanut allergy aged 1 to 3 years. This subgroup analysis assessed response rates for prespecified subgroups, including children with asthma, AD/eczema, and CFA. The safety profile of VP250 was evaluated by atopic condition in all randomized participants who received at least 1 dose.

Results: Responder rates were significantly greater with VP250 vs placebo, irrespective of the presence of atopic conditions. There was no significant interaction effect between participants with an atopic comorbidity and those without. The safety profile was generally similar across subgroups without any additional safety signals. There was no clinically meaningful change in severity of AD in those receiving VP250, regardless of baseline AD status. Rates of anaphylaxis were higher in those with AD or CFA receiving VP250 vs those without; however, these imbalances were also observed in the placebo group.

Conclusion: The results suggest that 12 months of treatment with VP250 was effective in desensitizing children with peanut allergy aged 1 to 3 years, with no difference in efficacy and a favorable safety profile, regardless of the presence of atopic comorbidities.

Trial registration: ClinicalTrials.gov Identifier: NCT03211247.