Among children with peanut allergy, epicutaneous immunotherapy induced a statistically significant response compared with placebo in a phase 3, randomized, double-blind trial conducted at 31 sites in 5 countries. However, it did not meet the prespecified lower bound of the confidence interval (CI) criterion for a positive trial result. Participants included 356 peanut-allergic children aged 4-11 years without a history of a severe anaphylactic reaction developing objective symptoms during the double-blind, placebo-controlled food challenge at an eliciting dose of ≤300 mg of peanut protein. Interventions included daily treatment with peanut patch containing either 250 µg of peanut protein (n=238) or placebo (n=118) for 12 months. The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose. Researchers found:

• Among 356 participants (median age 7 years, 61.2% male) randomized, 89.9% completed the trial with mean treatment adherence at 98.5%.
• The responder rate was 35.3% with peanut-patch treatment vs 13.6% with placebo.
• However, the prespecified lower bound of the CI threshold was not met.