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QUANTITATIVE RISK REDUCTION THROUGH EPICUTANEOUS IMMUNOTHERAPY (EPIT): RESULTS FROM THE PEPITES PHASE III TRIAL

https://doi.org/10.1016/j.anai.2018.09.032Get rights and content

Introduction

Peanut allergy prevalence is increasing world-wide and currently no FDA-approved treatment is available. Epicutaneous immunotherapy (EPIT) with Viaskin Peanut (VP250) is being studied in peanut-allergic subjects using a novel single-dose (250 microgram peanut protein) patch. Phase II and III clinical trials have demonstrated a statistically significant benefit of VP250 over placebo through increased eliciting doses on double-blind, placebo-controlled food challenges (DBPCFC). As cross-contamination exposures to peanut through packaged goods are a leading concern and cause of allergic reactions, we aimed to quantify "real world" benefits of EPIT in the pediatric (4-11 years old) peanut-allergic population enrolled in a VP250 Phase III trial.

Methods

Quantitative risk assessments were conducted simulating accidental exposures to peanut protein in peanut-allergic individuals consuming selected packaged foods (cookies, croissants, doughnuts, ice cream). Clinical data from the PEPITES (Peanut EPIT Efficacy and Safety) Phase III trial were utilized to calculate the population relative risk reduction geometric mean for active (n= 238) and placebo (n=118) groups.

Results

Geometric mean relative risk reductions for children were calculated between 74.7% and 96.6% in the active group, depending on the assumptions, versus less than 2.5% in the placebo group under any conditions.

Conclusions

VP250 has previously been found to offer a statistically significant benefit over placebo when assessed on DBPCFC. Here we demonstrate substantial reduction in allergic reaction risk due to unexpected exposure to peanut protein in packaged food products in a pediatric population treated with VP250. EPIT with VP250 seems to provide clinically relevant benefit to the peanut-allergic pediatric population.

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