Children 1 to 3 years old undergoing a year of epicutaneous immunotherapy with a patch containing 250 µg of peanut protein showed a statistically significant response to treatment, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting, held from November 10 to 14, 2022, in Louisville, Kentucky.
Researchers for multicenter, phase 3 EPITOPE trial (ClinicalTrials.gov Identifier: NCT03211247) sought to determine a possible peanut allergy treatment for children under 4 years of age by testing the safety and efficacy of epicutaneous immunotherapy. The trial involved children with peanut allergies who met stopping criteria in a double-blind, placebo-controlled food challenge (DBPCFC) at an eliciting dose of 300mg or less of peanut protein. These children were randomly assigned at a 2:1 ratio to receive either a peanut patch for 12 months of daily treatment (n=244) or a placebo patch (n=118). Researchers’ primary outcome was percentage difference in children’s response in the active patch and placebo groups, determined by the DBPCFC eliciting dose at baseline and after 12 months of treatment. Safety was evaluated based on treatment-emergent adverse events (TEAEs).
Of the 362 children (median age, 2.5 years; 68.8% male) included in the study, 84.8% completed treatment. About 67% of children in the active peanut patch cohort and 33.5% in the placebo patch cohort achieved the primary efficacy endpoint (difference, 33.4%; 95% CI, 22.4%-44.5%; P <.001). In addition, 64.2% of children who received the active patch and 29.6% who received the placebo (difference, 34.7%; P <.001) had a peanut protein eliciting dose of 1000 mg or greater.
Most TEAEs were mild or moderate reactions at the application site. Serious TEAEs occurred in 8.6% of children using the peanut patch and in 2.5% children using the placebo patch. Among children using the peanut patch, 4 (1.6%) had treatment-related anaphylaxis and 8 (3.3%) discontinued due to a TEAE.
Researchers concluded that, “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.”
Burks A, Sindher S, Wang J, et al. EPITOPE study results: phase 3, randomized, double-blind, placebo-controlled study of epicutaneous immunotherapy in peanut-allergic toddlers. Ann Allergy Asthma Immunol. 2022;125(5):S12. doi:10.1016/j.anai.2022.08.540
This article originally appeared on Pulmonology Advisor.