The world’s first treatment for potentially fatal peanut allergies could be available to kids as early as next year, thanks to a successful experiment on peanut-tolerance that will be published Thursday in the prestigious New England Journal of Medicine.
The research team, led by UNC-Chapel Hill pediatrics professor Wesley Burks, showed that most children with peanut allergies can build up resistance by ingesting miniscule amounts of peanut and incrementally increasing the daily dosage. In the year-long clinical trial, involving 551 kids in the United States and Europe, two-thirds of the kids were able to train their immune systems to tolerate the equivalent of eating two peanuts, with very minor side effects.
Successfully building up tolerance for two peanuts signals a breakthrough for 1 percent of American children who are dealing with the life-complicating allergy, in which a bite of a candy bar or a cookie could cause the throat to constrict and the skin to break out in hives. For the most sensitive kids, mere skin contact with a surface that contains peanut residue is enough to trigger anaphylaxis, a severe allergic reaction that often requires a rescue shot of epinephrine and a precautionary visit to the hospital emergency room.
“Families live in fear their child will accidentally eat something with a peanut in it,” Burks said in a phone interview.
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Tricking your body to be able to handle a peanut, or even two, is no easy task. Of the kids aged 4 to 17 years who participated in the test, 80 withdrew for a variety of reasons: 43 had adverse events, including one requiring emergency hospitalization. In 31 cases, parents or guardians pulled the kids out of the study. Sixteen of the kids dropped out because of stomach discomfort from the regimen that starts out with 3 milligrams of peanut protein, equivalent to 1/100th of a peanut.
The kids who took the powdered peanut protein had to avoid strenuous exercise 2 hours before and after their dose. As a safety precaution the kids could not go to sleep for 2 hours after dosing.
And ingesting the protein isn’t exactly a barrel of monkeys, said Courtney Doi, a Mebane resident whose 11-year-old daughter Meredith is involved in a parallel safety study that ends in December.
“She swears it tastes awful — in pudding, in ice cream — she hates it,” Doi said in a phone interview. “She had stomach aches and threw up a few times. It was hard and we weren’t sure we’d be able to stay with the study.”
Burks’ research tested a product called AR101, a powdered form of protein extracted from peanuts, as a potential drug to develop peanut resistance. AR101 is being developed by Aimmune Therapeutics, a Brisbane, Cal.-based pharmaceutical company.
The results of the clinical trial, conducted at 66 sites in 10 countries, including UNC-Chapel Hill’s Food Allergy Institute and Asthma & Allergy Specialists in Charlotte, were presented Sunday in Seattle at a conference of the American College of Allergy, Asthma & Immunology.
Almost all the kids had some kind of adverse event, although usually relatively mild. At the end of a year, three-fourth of the kids could tolerate the equivalent of one peanut, two-thirds of the kids tolerated two peanuts, and about half could tolerate three peanuts in one sitting.
In the “exit food challenge,” in which the kids’ tolerance levels were put to the test, 10 percent of the kids taking the peanut drug (as opposed to a placebo), had reactions severe enough to require a rescue shot of epinephrine.
Aimmune expects to apply for approval from the U.S. Food & Drug Administration this year, with a commercial launch expected in mid-2019. The medication, once approved, would come in pill form.
A French company is developing a rival product, called the Viaskin peanut patch, which would also launch next year if approved by the FDA.
Burks said the cost for AR101 hasn’t been announced yet. It would be taken daily, as in the clinical trial, until the child builds up resistance. It’s not clear yet if the child would continue taking the medication daily for the rest of their lives, or if they could maintain resistance with weekly doses.
Meredith Doi, the Mebane 6th-grader in the ongoing safety study, has worked her way up to tolerating the equivalent of one peanut. Her mom, Courtney Doi, said that is enough to protect her daughter from accidentally ingesting peanut residue in school, at a birthday party or at a restaurant.
“That’s really to keep her immune system thinking it’s okay,” Doi said. “It’s for my peace of mind.”