The results further support the overall benefit of epicutaneous immunotherapy.
David Fleischer, MD
Daily epicutaneous immunotherapy treatment for peanut allergy beyond 1 year leads to a continued response from a well-tolerated, simple-to-use regimen.
David Fleischer, MD, and colleagues assessed the interim safety and efficacy of an additional 2 years of epicutaneous immunotherapy from the ongoing five-year treatment open-label extension PEOPLE study. The team found the immunotherapy demonstrated durable, long-term clinical benefit with an additional 2 years of treatment in children 4-11 years old with peanut allergy.
The PEOPLE study is an open-label follow-up of the PEPITES study to evaluate DBV712 250 µg following up to 5 years of active treatment. Participants in the PEOPLE study received 24 months of open-label treatment if they were in the active treatment arm of PEPITES. Children 4-11 years old were initially enrolled in PEPITES.
Eligibility criteria included reacting on double-blind, placebo-controlled food challenges to an eliciting dose of <300 mg of peanut protein at baseline. Those who completed PEPITES were offered enrollment in PEOPLE. Patients with a history of severe anaphylaxis were excluded.
All participants in PEOPLE were given an unblinded daily dose of 250 µg peanut protein per patch. They were required to maintain a peanut-free diet and had epinephrine autoinjectors available.
The study population consisted of 2 groups according to the treatment allocation in PEPITES. The first group was the DBV712 250 µg group with subjects who received active treatment in both PEPITES and PEOPLE. The second group was the placebo plus DBV712 250 µg group of patients who received placebo in PEPITES and DBV712 250 µg in PEOPLE.
Fleischer and the team’s key outcomes included the percentage of DBV712 250 µg patients who reached an eliciting dose of >1000 mg after 3 years of active treatment, along with the difference between who reached the eliciting dose after 3 years and the percentage of those who reached it after 1 year of active treatment. Additional endpoints included eliciting dose at each time point, cumulative reactive dose of peanut protein, the percentage of those unresponsive to the highest dose of peanut protein, and the percentage of responders defined per the PEPITES primary outcome—subjects with baseline eliciting dose of ≤10 mg reaching ≥300 mg or baseline eliciting dose between >10 mg and ≤300 mg reaching ED of ≥1000 mg.
Of the 213 eligible patients, 198 (93%) who received DBV712 250 µg in PEPITES entered PEOPLE. Among the 198, 71% had assessable double-blind, placebo-controlled food challenges at month 36.
More than half of the patients (51.8%) reached an eliciting dose of >1000 mg at month 36, compared with 40.4% at month 12. A majority of participants (75.9%) demonstrated increased eliciting dose compared to baseline. Few (13.5%) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. The team reported the median cumulative reactive dose increased from 144 to 944 mg.
There were 18 participants who underwent an optional sustained unresponsiveness assessment. Of the, 77.8% maintained an eliciting dose of >1000 mg at month 38.
The investigators found compliance was high (96.9%) and withdrawals due to treatment-related adverse events were low (1%).
The results further support the overall benefit of epicutaneous immunotherapy, the team concluded.
The study, “Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results,” was published online in the Journal of Allergy and Clinical Immunology.