Peanut allergy is a severe and potentially life-threatening food allergy. But, the landmark phase 3 PALISADE trial published Nov. 22, 2018 in the New England Journal of Medicine has provided a breakthrough and brought hope for children and adolescents who have peanut allergy.
The trial showed that oral immunotherapy 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.
Researchers from Evelina London Childrens Hospital and Kings College London screened 551 participants with peanut allergy for the trial; of these, 496 were aged 4 to 17 years, who were randomly assigned, in a 3:1 ratio, to receive placebo or AR101, a peanut-derived investigational biologic oral immunotherapy drug in an escalating-dose program. Doses were gradually increased every two weeks for a period of six months, before continuing on a “maintenance dose” of peanut for a further six months.
The results showed that 67.2% (250/372) of those on AR101 treatment were able to ingest a dose of at least 600 mg of peanut protein (a whole peanut kernel contains approximately 250–300 mg of peanut protein), without dose-limiting symptoms, at the exit food challenge as compared to only 4.0% (5/124) of the placebo-treated participants.
Adverse events were seen in 95% of participants in both groups.
AR101 also showed a favorable safety profile. The maximum severity of symptoms was moderate in 25% of those in the active-drug group and 59% of the participants in the placebo group and severe in 5% and 11%, respectively, during the exit food challenge.
A total of 34.7% of the participants in the active-drug group had mild events vs 50.0% of those in the placebo group; 59.7% and 44.4% of the participants, respectively, had moderate grade events and 4.3% and 0.8%, respectively, had severe grade events.
Efficacy was not shown in the participants 18 years of age or older.
(Source: PALISADE Group of Clinical Investigators. AR101 oral immunotherapy for peanut allergy. N Engl J Med. 2018 Nov 18. doi: 10.1056/NEJMoa1812856. [Epub ahead of print]