Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results

Abstract: Background We previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT™) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250μg) in a 12-month randomized controlled study (PEPITES) of peanut-allergic children aged 4-11 years. Objective To assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) open-label extension PEOPLE study. Methods Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250μg, subjects who had received DBV712 250μg in PEPITES underwent Month-36 double-blind, placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment. Results 198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36. At Month 36, 51.8% (73/141) of subjects reached an eliciting dose (ED) of ≥1000 mg, compared with 40.4% (57/141) at Month 12. 75.9% (107/141) demonstrated increased ED compared to baseline. 13.5% (19/141) tolerated the full DBPCFC of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. 18 subjects underwent an optional SU assessment; 14/18 (77.8%) maintained an ED of ≥1000 mg at Month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%). Conclusion These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.