Peer-reviewed article
Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results
David Mark Fleischer, Wayne G. Shreffler, Dianne Elizabeth Campbell, Todd David Green, Sara Anvari et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study followed children with peanut allergy who received epicutaneous immunotherapy (EPIT) for three years. After two additional years of treatment beyond the initial trial, over half of children could tolerate doses of at least 1000 mg of peanut protein, compared to 40% after one year. The treatment was well-tolerated with high compliance and no serious safety concerns in years two and three.
Key points
- 51.8% of children reached an eliciting dose of ≥1000 mg at month 36, compared with 40.4% at month 12
- Median cumulative reactive dose increased from 144 mg to 944 mg over the study period
- 13.5% of children tolerated the full 5444 mg food challenge dose
- Local skin reactions at the patch site were common but decreased over time
- No treatment-related epinephrine use occurred in years 2 or 3, with high compliance (96.9%) and low withdrawal rate (1%)
Limitations
This was an open-label extension study without a control group after month 12, so it cannot definitively prove that continued treatment causes the improvement. The study included only children who completed the initial trial and enrolled in the extension, which may represent a more motivated or tolerant population.
Abstract
BACKGROUND: The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). OBJECTIVE: We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. METHODS: Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. RESULTS: Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose 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 were low (1%). CONCLUSIONS: 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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention