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.
Fleischer DM, Greenhawt M, Sussman G, et al. Effect of epicutaneous immunotherapy vs placebo on reaction to peanut protein ingestion among children with peanut allergy: The PEPITES randomized clinical trial. [Published online ahead of print February 22, 2019]. JAMA. doi:10.1001/jama.2019.1113.