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

Open AccessPublished:November 27, 2021DOI:https://doi.org/10.1016/j.jaip.2021.11.017
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      HIGHLIGHTS BOX

      • What is already known about this topic?
      • In previous phase 2b and 3 clinical trials, epicutaneous immunotherapy (EPIT) with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children.
      • What does this article add to our knowledge?
      • This article provides additional information on the safety profile of EPIT with Viaskin Peanut 250 μg in a setting that approximates potential real-world use.
      • How does this study impact current management guidelines?
      • The safety data for Viaskin Peanut 250 μg reported herein are consistent with previous phase 2b and 3 studies, which may further support the use of EPIT as a new potential treatment option for peanut allergy.

      ABSTRACT

      Background

      Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin™ Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children.

      Objective

      To examine the safety of VP250 in children, using a study design approximating potential real-world use.

      Methods

      REALISE is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported.

      Results

      Three hundred ninety-three children were randomized 3:1 to receive VP250 (n=294) or placebo (n=99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued due to adverse events. Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall adverse event rates were similar among participants with and without history of peanut anaphylaxis.

      Conclusions

      In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

      KEY WORDS

      ABBREVIATIONS:

      AEs (adverse events), DBPCFC (double-blind placebo-controlled food challenge), EPIT (epicutaneous immunotherapy), ICH GCP (International Council for Harmonisation Good Clinical Practice), IgE (immunoglobulin E), IgG4 (immunoglobulin G4), MedDRA (Medical Dictionary for Regulatory Activities), NIAID (National Institute of Allergy and Infectious Diseases), OIT (oral immunotherapy), psIgE (peanut-specific IgE), Q1 (quarter 1), Q3 (quarter 3), RDBPCT (randomized), double-blind (placebo-controlled trial), SAEs (serious adverse events), SD (standard deviation), SPT (skin prick test), TEAEs (treatment-emergent adverse events)