AR101 Oral Immunotherapy for Peanut Allergy

Abstract

To determine if AR101 is a safe and effective treatment to prevent peanut reactions due to accidental exposure.Participants (496, 4–17 years old) were randomly assigned 3:1 to receive AR101 (peanut-derived investigational drug) or placebo (oat flour). The majority of the participants had a history of peanut anaphylaxis (72%), asthma (53%), and multiple food allergies (66%). All participants had dose-limiting symptoms at a dose of 100 mg of peanut protein in a double-blind placebo-controlled food challenge at baseline.Participants began a 1-day supervised dose escalation phase from 0.5 to 6 mg. The dose was then increased gradually every 2 weeks from 3 to 300 mg. A maintenance dose of 300 mg was continued for 24 weeks.A double-blind placebo-controlled food challenge was done at the end of the trial. Among the participants, 250 of the 372 (67.2%) in the active drug group and 5 of 124 (4%) in the placebo group were able to tolerate a dose of 600 mg or more of peanut protein without dose-limiting symptoms. The key secondary endpoints were tolerating 300 mg (76.6%) or 1000 mg (50.3%) compared with those in the placebo group (8.1% and 2.4%, respectively). Severe reactions occurred in 4.3% of the active drug group and 0.8% of the placebo group. Participants in the active treatment group compared with placebo had a higher incidence of gastrointestinal events (85.8% vs 69.4%), respiratory tract events (81.2% vs 71.8%), skin reactions (66.9% vs 55.6%), and immune system concerns (68.9% vs 8.9%). Overall, 43 (11.6%) in the active treatment group and 3 (2.4%) in the placebo group withdrew because of adverse events. Gastrointestinal symptoms causing study withdrawal occurred in 6.5% of the active treatment group and 1.2% of the placebo group. During the course of the trial, 52 participants (14%) in the active drug group and 8 participants (6.5%) in the placebo group were given epinephrine for grade 1 or 2 reactions; of these, the majority (92.7%) was treated with a single dose of epinephrine.Overall, 67% of the participants 4 to 17 years old were able to tolerate 600 mg of peanut protein (2 kernels) during the exit food challenge.These data are important, and AR101 will give health care providers a standardized way forward to treat this potentially life-threatening condition. It is hopeful that the product will be US Food and Drug Administration approved by the time this synopsis is published.