Study results, announced Sunday at a conference in Seattle, may lead to approval of what could be the first oral medication that ameliorates reactions in children with severe peanut allergies.
Ever since a bite-size peanut-butter cracker made him sputter and cough and break out in hives when he was a toddler, Carter Grodi has been under doctors’ orders to stay away from peanuts. He brought his own cupcake to school birthday parties, learned to read food labels and turned 15 without ever tasting a Kit Kat, Twix or Three Musketeers bar, all of which may contain traces of peanut because they are made in facilities that process the nuts.
But last year, Carter, now 16, gorged on those candies for the first time without having a reaction. He had just completed a yearlong clinical trial of an oral immunotherapy regimen that aims to reduce children’s sensitivity to peanut allergens by gradually exposing them to peanut protein over the course of six months, starting with minute amounts that are carefully measured and increased incrementally under medical supervision as tolerance develops.
The goal of the treatment is not to cure the allergy or enable children to eat peanut butter sandwiches, but to reduce the risk that an accidental exposure to trace amounts will trigger a life-threatening reaction in someone with a severe allergy, and relieve the fear and anxiety that go along with severe peanut allergies.
The results, announced Sunday at a conference of the American College of Allergy, Asthma & Immunology in Seattle, may lead to approval of what could be the first oral medication that ameliorates reactions in children with severe peanut allergies.
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After six months of treatment followed by six months of maintenance therapy, two-thirds of the 372 children who received the treatment were able to ingest 600 milligrams or more of peanut protein — the equivalent of two peanuts — without developing allergic symptoms. By contrast, only 4 percent of the 124 children who had been given a placebo powder were able to consume the same amount of peanut without reacting.
The treatment does not work for everyone. Though only 4.3 percent of children receiving the active drug experienced side effects categorized as severe, compared with less than 1 percent of the children on placebo, 20 percent of the children in the active treatment group withdrew from the study, more than half of them because of adverse events. Fourteen percent of those on active treatment received injections of epinephrine, a drug used in emergencies, including one child who experienced anaphylaxis and required three EpiPen injections. By contrast, only 6.5 percent of those on the placebo received epinephrine.
Demand for the new drug is expected to be high, and though it is made of peanuts, advocates for people with peanut allergies are already expressing concern about how it will be priced and whether it will be covered by insurance.
One in 50 U.S. children is allergic to peanuts. Peanut allergies are believed to cause more deaths from anaphylaxis, a constriction of the airways, than any other food allergy. Deaths are rare, and the precise number is not known. Patients do not generally outgrow peanut allergies, so they must be vigilant throughout their lives.
The double-blinded, placebo-controlled trial of the drug, called AR101 and developed by Aimmune Therapeutics, is to be published Thursday in The New England Journal of Medicine. Aimmune Therapeutics designed and sponsored the clinical trial, which was carried out at multiple medical centers. Five of the 13 authors of the paper are company employees, and the others serve on the company’s scientific advisory board, for which they are compensated.
Experts who were not involved in the trial said the outcomes exceeded their expectations, calling the results “potentially lifesaving.” But they also cautioned that the treatment does not cure peanut allergies and should not be attempted at home. They emphasized that children who complete the regimen need to continue to eat a peanut-free diet and may need to keep up maintenance therapy with minute doses of peanut, possibly for the rest of their lives.
“This is not the cure, but it is a good first step,” said Dr. James R. Baker Jr., chief medical officer of Food Allergy Research & Education, a nonprofit advocacy group that focuses on food allergies, noting the results were better than he expected. Until now, he said, “We’ve had nothing, nothing to give these poor kids that can keep them from having these reactions and put them in a much more positive outlook on life. It’s just a wonderful thing to have.
“The fact that the kids were eating the equivalent of a peanut a day pretty much tells you that if they accidentally eat a peanut, they won’t have a life-threatening reaction,” Baker said.
For children like Carter Grodi, a junior in high school in Ocala, Florida, who completed the treatment a year ago and continues to ingest a small amount of peanut every day to maintain his low-level tolerance, the treatment was transformative, making it easier to go out with friends and make plans to go away for college.
“I can just go to college, meet a bunch of kids, go sit in a place another kid was the day before and not have to wipe off the desk, and not worry about what my friends are eating around me,” he said. “To me, a peanut was like a weapon, like you have a gun to your head and you could have the trigger pulled any time. There’s not really that gun anymore.”