Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

To assess the safety and tolerability of an epicutaneous peanut immunotherapy patch (Viaskin Peanut 250μg [VP250]) in a population of children with peanut allergy.

The study enrolled 393 children aged 4 to 11 years with physician-diagnosed peanut allergy, including those with a history of anaphylaxis. The participants had a high prevalence of other allergic conditions and 72.3% had prior anaphylaxis to peanut.

REALIZE is a multicenter, phase 3 trial consisting of a 6-month, randomized, double-blind, placebo-controlled trial (the safety outcomes from which were reported in this paper) followed by an open-label treatment period. Participants in this trial were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months. Parent diaries were maintained to monitor adverse events.

Local skin reactions were reported in all participants receiving VP250 and 83.8% of participants receiving placebo. Epinephrine-treated allergic reactions attributed to VP250 were reported in 2.4% (n = 7). There were no cases of severe anaphylaxis. Only 1.4% of participants discontinued VP250 because of adverse events.

The REALIZE study demonstrated that VP250 is safe, well tolerated, and associated with high adherence to treatment in peanut-allergic children.

Immunotherapy for the treatment of food allergy is a rapidly growing area of research and an increasing number of allergists now employ oral immunotherapy. These data from the REALIZE clinical trial provides evidence of the safety and tolerability of epicutaneous immunotherapy with VP250 (a patch containing peanut protein) for peanut-allergic children. Efficacy studies are emerging with promising results on efficacy. This suggests that a patch worn on the skin may be an alternative way to desensitize children with food allergy in the future.