The trial involved 362 children with peanut allergy from ages 1 to 3 in eight countries, including the United States, Canada and Australia. Nearly 85 percent of the toddlers completed the trial; most of those who did not were withdrawn by their parent or guardian. The trial involved a toddler wearing either a peanut patch containing 250 micrograms of peanut protein — about 1/1,000th of a peanut — or the placebo patch between their shoulder blades every day for a year.
Among the children who wore the peanut patch, called Viaskin, two-thirds were able to tolerate a higher amount of peanut protein at the end of the year. (A third of the placebo group were also able to tolerate higher amounts; some children outgrow peanut allergy.)
For parents and caregivers of young children with peanut allergy, the patch could be a useful tool to defend those under age 4 against potentially life-threatening accidental consumption or exposure in areas such as cafeterias and playgrounds. Peanut allergy is one of the most common allergies among children, and there is no cure for food allergies, according to the Centers for Disease Control and Prevention.
A drug used to treat peanut allergy in children ages 4 to 17 was approved by the Food and Drug Administration in 2020, but the therapy, called Palforzia, has struggled to gain traction with consumers, as it is costly and requires a battery of medical appointments to begin treatment. Nestlé bought the company that developed the drug, but is now trying to sell it amid disappointing takeup, Barron’s reported, citing Nestlé chief executive Mark Schneider’s comments at an investor conference.
In a news release on Wednesday, DBV Technologies expressed hope that the newly published data could help the Viaskin patch secure FDA approval.
The study’s lead author, Matthew Greenhawt, who specializes in allergies and immunology at Children’s Hospital Colorado, said in the news release that the trial “shows that, if approved, the Viaskin Peanut patch has the potential to give new hope to toddlers and their families who currently have no approved treatment options and must instead rely on avoidance, which can severely impact quality of life.”
But the phase three trial had various limitations, the study acknowledged, including the exclusion of children with severe peanut allergies because of safety concerns. It also lacked diversity, as most of the toddlers in the trial — 65 percent in the peanut patch group and 59 percent in the placebo group — were White. Only one child identified as Black was included in each group. (The study said the lack of diversity was “consistent with other food-allergy treatment studies.”)
Nearly all of the participants experienced “adverse events” during the trial, such as itching or swelling at the site of the patch. One “serious adverse event” — periorbital edema, or swelling around the eyes — associated with the peanut patch was reported in that group, with the majority of the adverse events characterized as mild or moderate. Four anaphylactic reactions related to the peanut patch were reported.
Alkis Togias, chief of the allergy, asthma and airway biology branch within a division of the National Institutes of Health, said in an editorial accompanying the study that it was “important to consider the pros and cons” of treatments such as the skin patch versus “oral peanut immunotherapy,” which involves consuming small amounts of peanuts to reduce the severity of the allergy. Togias, who was not involved in the study, noted that a separate trial of oral immunotherapy appeared to have been more successful at protecting against allergic reactions, but cautioned that it was difficult to compare two separate studies.
Still, he said, the peanut patch trial was “very good news for toddlers and their families as the next step toward a future with more treatments for food allergies.”