At the College’s Annual Scientific Meeting, new research presented showed promise for a treatment to help people with severe peanut allergy tolerate accidental peanut exposure. The abstract titled Age-Related Findings from the Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization (PALISADE) Study, was presented by Stephen Tilles, MD, FACAAI, College past president. The results of the study were published in the New England Journal of Medicine. The study shows it is possible for some people with peanut allergy to protect themselves from accidental ingestion by building up their tolerance to peanut over time.
“We’re excited about the potential to help people with peanut allergy protect themselves against accidentally eating a food with peanut in it,” says Dr. Tilles. “The treatment involved building up a daily dose of peanut protein to the equivalent of one peanut per day. At the end of the study, two-thirds of the participants were able to tolerate a single dose of the equivalent of two peanuts per day after.”
Study participants ranged in age from 4 to 55 years, most were 4 to 17, and all had been previously diagnosed with peanut allergy. One third of the participants were given a placebo, while the remaining two-thirds were given peanut protein powder in increasing amounts throughout the study. The PALISADE study was the largest double-blind, placebo-controlled peanut allergy trial ever conducted. Overall, about eight out of 10 of the 551 participants who were randomized to active treatment ended up tolerating six months of a daily dose of 300 mg of peanut (the equivalent of about one peanut a day). The average accidental exposure amounts to about half a peanut.
The primary objective of the study was met, including that 67% of the actively-treated 4-17 year-old participants were able to tolerate a single dose of at least 600 mg of peanut (about two peanuts), compared to only 4% of those treated with placebo. The study was geared specifically for ages 4-17 years and the treatment effect in that age group was the most significant. Among the 10% of PALISADE participants who were ages 18-55, there was a trend toward a treatment effect though additional studies to assess a significant effect in this age group are needed.
The symptom severity and epinephrine use during oral challenges at the end of the study was blunted among the actively-treated participants. Adverse events led to withdrawal from the study in 10-17% of actively-treated and 0-2.9% of placebo recipients across the age groups. There were no life-threatening adverse events during the entire study, and the frequency and severity of adverse events was as expected. Rate of withdrawals from the study due to gastrointestinal issues and the single case of eosinophilic esophagitis were lower than expected.
“In this highly-allergic population, treatment with AR101 resulted in significant clinical desensitization and had an acceptable safety profile,” said Dr. Tilles. “Publication of these phase 3 data in the New England Journal of Medicine is an exciting step toward the goal of providing FDA-approved options for peanut-allergic patients.”
While researchers admit the results of the study aren’t a quick-fix and do not mean that peanut-allergic patients will be able to eat peanuts, it demonstrates a huge breakthrough. The study authors are hoping that the treatment will be approved by the FDA and available in the second half of 2019.
There are currently no approved treatment options for peanut allergy. If this treatment is approved by the FDA, it will be available by prescription, and people with peanut allergy will need to continue taking it to stay protected against accidental consumption. Once someone stops the treatment, there is no longer a protective effect.