A wearable patch could prevent severe allergic reactions in toddlers with peanut allergies, according to the results of a promising clinical trial.
The late-stage trial, which involved more than 200 children ages 1 to 3 with peanut allergies, found that after wearing the experimental patch around 22 hours a day for a year, 67% were able to tolerate 300 to 1,000 milligrams of peanut protein — the equivalent of one to four peanuts. The findings were published Wednesday evening in the New England Journal of Medicine.
“Amazingly, not only did it raise the amount of peanut [tolerance] in these children, but the nature of the reaction also changed. There was a decrease in the number of severe reactions,” said Dr. Matthew Greenhawt, the study’s lead author and director of the Food Challenge and Research Unit at Children’s Hospital Colorado.
The patch, a product called Viaskin from biopharmaceutical company DBV Technologies, contains a small dose of peanut protein equal to about 1/1,000th of a peanut kernel. A new patch is applied each day and worn between the shoulder blades so the skin absorbs the protein. Immune cells then carry the protein to other parts of the body, where they help suppress the allergic response, according to the company.
There are no approved treatments for children under 4 with peanut allergies. The Food and Drug Administration has approved one for those ages 4 to 17, however: a powder called Palforzia that can be mixed with foods like applesauce, yogurt or pudding. The powder is similarly meant to lower the risk of severe allergic reactions by increasing kids' tolerance to peanuts over time.
The Viaskin trial, however, is the first to study a non-oral option for this younger age group.
Dr. Pharis Mohideen, DBV Technologies’ chief medical officer, said the goal of Viaskin isn’t to get kids to tolerate peanut-butter-and-jelly sandwiches or eliminate an allergy altogether.
“We’re trying to build a protective layer for them so that if there is an accidental peanut exposure, they won’t have a reaction, or that reaction will be very mild and not send them to the emergency room,” he said.
Getting kids with an allergy to a point where they can tolerate several peanut kernels, Mohideen added, is “absolutely life-changing” and would ease parents’ anxiety about taking their kids to restaurants or on airplanes.
“If a label says ‘may contain peanuts,’ but you know you can tolerate a full peanut kernel, the likelihood that that product is safe is pretty high,” he said.
About 1 in 50 children in the U.S. have a peanut allergy. A 2018 report determined that the prevalence of peanut allergies in the country tripled in the previous two decades, but the reasons for the trend aren’t fully clear.
Up to 20% of people with a peanut allergy eventually outgrow it, though some people’s allergies worsen over time.
In the Viaskin trial, four of the participating toddlers developed anaphylaxis — an allergic response often characterized by difficulty breathing, swelling in the throat, pale skin, blue lips, fainting or dizziness. The reactions weren't considered severe, though three required epinephrine, an injection more commonly known as an EpiPen.
Greenhawt said most side effects in the trial were localized skin reactions.
Other research into peanut allergy interventions is ongoing. Researchers at the UNC School of Medicine recently completed a Phase 2 trial in children ages 1 to 11 that involved putting a tiny amount of peanut protein under the tongue. Out of 47 kids who completed the treatment, 70% were able to tolerate the equivalent of around three peanuts, and 36% were able to tolerate the equivalent of around 16 peanuts.
Viaskin is also being studied in children ages 4 to 7 and has previously been studied in adolescents and adults. But Greenhawt said the patch seems to be most effective in toddlers because younger kids’ immune systems are more malleable.
Dr. Kanwaljit Brar, a pediatric allergy and immunology specialist at Hassenfeld Children’s Hospital at NYU Langone, said most of her patients with peanut allergies are babies and toddlers. Her older pediatric patients have seen improvements from Palforzia, she added, but it’s not suitable for everyone because it requires doctors’ visits every two weeks and isn’t covered by all insurance providers.
The patch could eliminate some of those barriers to access, Brar said. "I actually have a daughter with a peanut allergy, and this would be a great option for someone like me who’s a really busy parent," she said.
Mohideen said DBV Technologies eventually plans to submit Viaskin to the FDA for approval, but added that the agency has asked the company to gather more safety data about the patch in both toddlers and children before it applies. There is no specific timeline for completing an application yet, he said.