EPITOPE STUDY RESULTS: PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EPICUTANEOUS IMMUNOTHERAPY IN PEANUT-ALLERGIC TODDLERS

Abstract

<h3>Introduction</h3> No approved peanut allergy treatments exist for children <4 years old. This study aimed to assess the efficacy and safety of epicutaneous immunotherapy with a patch containing 250 µg peanut protein among peanut-allergic children ages 1-3 years. <h3>Methods</h3> In a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial (EPITOPE), peanut-allergic children developing symptoms meeting stopping criteria during double-blind, placebo-controlled food challenge (DBPCFC) at an eliciting dose (ED) ≤300 mg peanut protein were randomized 2:1 to 12 months of daily treatment with the peanut patch (n=244) or placebo patch (n=118). The primary outcome was the percent difference in responders between active and placebo, determined by DBPCFC ED at baseline and Month 12. Safety was assessed by treatment-emergent adverse event (TEAE) rate. <h3>Results</h3> Of 362 participants randomized (median age: 2.5 years, 68.8% male), 84.8% completed treatment. The primary efficacy endpoint was met by 67% receiving active peanut patch vs. 33.5% receiving placebo (difference=33.4%; 95% CI: 22.4–44.5% [p<i><</i>0.001]). Additionally, 64.2% active vs. 29.6% placebo recipients (difference=34.7%; [p<i><</i>0.001]) achieved a peanut protein ED ≥1000 mg. The majority of TEAEs were mild or moderate application site reactions. Serious TEAEs occurred in 8.6% peanut patch vs. 2.5% placebo recipients, with 1.6% (n=4) peanut patch subjects experiencing treatment-related anaphylaxis, and 3.3% (n=8) peanut patch subjects discontinuing due to a TEAE. <h3>Conclusions</h3> Twelve months of epicutaneous immunotherapy with a patch containing 250 µg peanut protein was associated with a statistically significant response vs. placebo among peanut-allergic children aged 1-3 years. Rates of treatment-related anaphylaxis and discontinuations due to TEAEs were low.