NEJM Publishes Highly Positive Study Data on OIT Biologic for Peanut Allergy

Faith Castro
November 22, 2018

The treatment is not a cure, and the regimen may not appeal to everyone with food allergies.

A large study provides the strongest evidence that children and teenagers can be desensitized to peanut allergies through controlled, escalating exposure to a substance that could otherwise trigger a life-threatening reaction - an advance that specialists said was likely to herald the development of new food allergy drugs.

It found those not usually able to tolerate exposure to even a tenth of a single peanut could "eventually cope with two whole peanuts".

Farmer's Cross, Cork first showed signs of his allergy to peanuts as a toddler when his face and eyes swelled up.

According to the study, oral immunotherapy for peanut allergy has been recommended against in most clinical settings because past trials have been limited by small sample sizes and differing methodologies. For the study, 551 participants with peanut allergies were given either a placebo or AR101 for six months, followed by six months of maintenance therapy.

It involved giving the child small doses of peanut flour and gradually increasing it to boost tolerance over time.

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"On average, the participants were able to tolerate a 100-fold higher dose of peanut at the end of the study than they did at the beginning".

Allergies to foods are on the rise and have been linked to various factors such as antibiotic use and breastfeeding.

By the end of the study, the patient's "reactions from the [OFCs] were much milder than prior to treatment", Dr. Tilles adds. The median dose of peanut that participants could tolerate at the start of the study was only 10 mg. More than 11 percent of children dropped out of the study due to adverse symptoms, and almost all of the children-even those in the AR101 group-had an adverse event during the trial period. One-third of the participants were assigned to the control (placebo) group, and the remainder were given daily doses of protein powder.

"These treatments really have the potential to transform people's lives", Brian Vickery, the study's lead author and director of the Children's Healthcare of Atlanta Food Allergy Program, tells Scutti.

Peanut allergy, a potentially life-threatening condition, has doubled over the last two decades and affects about 1 in 50 children in the UK. The agency has granted the treatment an expedited approval process, and AR101 could become available to patients by the summer of 2019. "If that happens, people who receive and are able to tolerate this treatment should be protected from accidental exposures".

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