Peanut allergies are believed to be on the rise in children, but there is currently no FDA-approved treatment for the potentially life-threatening condition. Now, ground-breaking research offers hope that a treatment—though not a cure—for peanut allergies is on the horizon.
As Roni Caryn Rabin reports for the New York Times, a study carried out by the biopharmaceutical company Aimmune Therapeutics exposed children to incrementally increasing amounts of peanut protein over the course of six months. By the end of the trial, two-thirds of children who were given the treatment, dubbed AR101, were able to tolerate 600 milligrams of peanut protein—the equivalent of two peanuts—without experiencing allergic symptoms.
Published in the New England Journal of Medicine, the study involved 551 participants, 496 of whom ranged in age from four to 17. Of these, 372 participants were given AR101, while another 124 children were given a placebo. A majority of the participants had a history of anaphylaxis, a severe and life-threatening allergic reaction.
At the start of the trial, the active-drug group was fed just three milligrams of AR101 for two weeks. Under medical supervision, the dose was gradually increased over the course of six months, exposing the children to higher and higher amounts of peanut protein until a dosage of 300 milligrams was reached. The children then underwent six months of maintenance therapy at 300 milligrams for another six months.
After a year of taking AR101, the children were tested to see how much peanut protein they could tolerate. Within the active-drug group, 67.2 percent of children were able to ingest 600 milligrams of peanut protein, compared to just four percent of the placebo group. Twenty-five percent of children who had received AR101 experienced moderate symptoms during a food challenge at the end of the treatment, versus 59 percent of participants who had been given a placebo. For five percent of the AR101 group and 11 percent of the placebo group, symptoms were severe.
But the fact that a majority of the AR101 group was able to tolerate the equivalent of two peanuts without symptoms is tremendously encouraging, experts say. Many children with peanut allergies and their families have to be constantly vigilant about peanut exposure. AR101 does not eliminate the allergy—children still won’t be able to eat their fill of Reese’s and Snickers—and patients may have to continue taking maintenance doses throughout their lives. But the treatment could offer the peace of mind that accidentally consuming a small amount of peanuts won’t trigger a reaction.
“It isn’t a cure like an antibiotic that makes a bug go away and it’s not there anymore,” Michael Perkin, a clinical epidemiologist and pediatric allergy consultant at the University of London who wrote a companion editorial to the study, tells Rabin. He adds, however, that “psychologically it makes a massive difference if you can keep your kid from living in fear. These kids can eat enough peanut that parents no longer will have to worry about their teenage daughter kissing someone who’s eaten peanut butter.”
Not all of the participants responded well to the trial. More than 11 percent of children dropped out of the study due to adverse symptoms, and nearly all of the children—even those in the AR101 group—had an adverse event during the trial period. The treatment process required a significant commitment; AR101 had to be administered every day, and after each dose, children were required to rest for two hours. They could not take a nap, however, for fear that they would experience a reaction while sleeping.
The participants were kept under close medical watch, and experts caution that parents should not try to increase their child’s peanut tolerance at home.
“The ability to flake off the right amount of peanut or buy a bag of peanut flour to do it is going to be fraught with potential hazards,” Perkin tells Sarah Boseley of the Guardian. “If a parent’s hand wavers they could end up with 10 or 20 or 50 times the dose and trigger a significant reaction.”
Aimmune Therapeutics plans to submit an application for marketing approval of AR101 to the FDA in December, reports CNN’s Susan Scutti. The agency has granted the treatment an expedited approval process, and AR101 could become available to patients by the summer of 2019.
“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. “I have seen it happen firsthand: the sense of relief [families] get when a child becomes desensitized.”