This article is part of Pulmonology Advisor‘s coverage of the American Academy of Allergy, Asthma & Immunology annual meeting, taking place in San Francisco, California. Our staff will report on medical research related to asthma, allergy, and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI 2019.
SAN FRANCISCO — Patients who were actively treated with AR101, an investigational oral biologic with a characterized peanut protein profile, reported accidental exposure to peanut less often, had fewer associated adverse events, and required less rescue medication compared with placebo, according to research findings presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) held February 22-25 in San Francisco.
In the phase 3 clinical trial Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE; ClinicalTrials.gov Identifier: NCT02635776) of experimental peanut desensitization, researchers recorded accidental food allergen exposure, related adverse events, and associated rescue medication in patients aged 4 to 17 years. Participants were selected if they had a reaction to ≤100 mg peanut protein via a screening double-blind placebo-controlled food challenge.
At the time of enrollment, 66% of participants reported food allergies other than peanut. Of the actively-treated patients, 20.7% reported 106 accidental exposures during the study, with 8.9% of patients attributing the exposures to peanut and 22.6% of patients to other foods. In patients given placebo, 32.3% reported 56 accidental exposures: 12.1% attributed the exposures to peanut and 22.6% attributed the exposures to other foods.
Adverse events occurred in 7.8% of the actively-treated patients vs 11.3% of the placebo group. In the active treatment group, 6.5% required treatment vs 10.5% in the placebo group. In addition, peanut exposures leading to adverse events were lower in the maintenance vs up-dosing period in the patients who were actively treated with AR101.
The researchers noted that if participants experienced only mild or no symptoms, it is possible that the number of exposures were underreported.
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Hourihane JO’B, Lieberman JA, Bird JA, et al. Accidental exposure to peanut and other food allergens: results from a phase 3, randomized, double-blind, placebo-controlled trial (PALISADE). Presented at: Annual Meeting of the American Academy of Allergy, Asthma & Immunology; February 22-25, 2019; San Francisco, CA. Abstract 804.