AR101, an investigational biologic oral immunotherapy drug derived from peanuts, reduced symptom severity and induced desensitization in children and adolescents with peanut allergies, according to research published in the New England Journal of Medicine.
A team of researchers for the Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization (PALISADE, ClinicalTrials.gov Identifier: NCT02635776) conducted an international, randomized, double-blind, placebo-controlled, phase 3 clinical trial to determine the efficacy and safety of AR101 in reducing allergic symptoms associated with peanut allergy in children and adolescents.
The primary outcome measured was the percentage of individuals aged 4 to 17 years who were able to ingest ≥600 mg peanut protein without dose-limiting symptoms.
The investigators screened 842 patients aged 4 to 55 years with allergic dose-limiting symptoms at ≤100 mg of peanut protein for eligibility; 750 of these patients were aged 4 to 17 years. A total of 551 eligible participants were then randomly assigned in a 3:1 ratio to be administered either AR101 or placebo; 496 participants were aged 4 to 17 years.
Over the course of 12 months, dose increased throughout the study in phases: the initial phase involved supervised dose escalation of AR101 from 0.5 mg to 6 mg occurring on 1 day; the increasing-dose phase, during which the dose of AR101 was increased every 2 weeks from 3 mg to 300 mg; and a 24-week maintenance phase with a steady dose of 300 mg.
Of the 372 pediatric participants in the AR101 group, 250 individuals (67.2%) were able to ingest ≥600 mg of peanut protein without dose-limiting symptoms compared with 5 of the 124 (4.0%) of the pediatric participants in the placebo group (difference, 63.2 percentage points).
Maximum symptom severity during the exit food challenge was reported as moderate in 25% and severe in 5% of participants in the AR101 group and moderate in 59% and severe in 11% of participants in the placebo group.
More than 95% of pediatric participants experienced adverse events: mild events were reported in 34.7% of the AR101 group and in 50.0% of the placebo group, while moderate events were reported in 59.7% of the AR101 group and in 44.4% of the placebo group. Severe events were reported in 4.3% of the AR101 group and in 0.8% of the placebo group. No significant efficacy was reported in participants aged ≥18 years.
“In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo,” the authors concluded.
Vickery BP, Vereda A, Casale TB, et al; for the PALISADE Group of Clinical Investigators. AR101 oral immunology for peanut allergy. N Engl J Med. 2018;379(21):1991-2001.