An experimental “peanut patch” is showing some promise for toddlers who are highly allergic to peanuts. The patch, called Viaskin, was tested on children ages one to three for a late-stage trial, and the results show that the patch helped children whose bodies could not tolerate even a small piece of peanuts safely eat a few. The findings were published May 10 in The New England Journal of Medicine.
Peanut allergies are a common and dangerous food allergy that affects about 2.5 percent of children in the United States. In children with allergies, their immune system overreacts to peanut-containing foods, which triggers everything from hives, to wheezing, to airway obstruction that can lead children hospitalized or worse. About 20 percent of these children will outgrow the allergy over time, but the majority must avoid peanuts for the rest of their lives. Additionally, they must carry rescue medication in the form of an injectable epinephrine divide like an EpiPen to prevent a severe allergic reaction if peanuts are accidentally eaten.
Peanut products and traces of peanuts can be found in a surprising number of foods: from candies to dipping sauces to ice cream. There is currently no cure for such an allergy. The only treatment is a peanut powder that protects against a severe reaction in children over 4 years-old. First approved by the Food and Drug Administration in 2020, the “oral immunotherapy” called Palforzia is consumed daily by children ages four to 17 to keep up their protection. It is now being tested in children under age four.
France’s DBV Technologies, makers of the new patch, is pursuing this skin-based immunotherapy treatment as an alternative way to desensitize the body and on younger children.
The trial of this new patch included 362 toddlers from eight countries. 244 of them were randomly assigned to receive the Viaskin patch. The patch contains 250 micrograms of peanut protein which is the equivalent of roughly 1/1000th of one peanut. 118 children received a placebo patch. They wore the patches every day for a year before undergoing screening.
After one year, two-thirds of the children who used the patch and one-third of the placebo group met the trial’s primary endpoint. The participants with a less sensitive peanut allergy could safely tolerate the peanut protein equivalent of eating three or four peanuts. Children who were more sensitive to peanut proteins could tolerate the equivalent of consuming one peanut.
If more patch testing works out, “this would fill a huge unmet need,” Matthew Greenhawt, an allergist at Children’s Hospital Colorado who helped lead the study told the Associated Press.
Almost all of the participants did have some adverse events, most commonly reactions at the application site like swelling, itching, and redness. Serious events were reported in 21 children who had the Viaskin patch and three that were in the placebo group. Anaphylaxis–a very dangerous allergic reaction–was reported in 7.8 percent of the patch recipients and 3.4 percent of the placebo group. The parents of eight participants pulled their children from the study due to the adverse events.
The study does have several limitations including that young children with a history of severe allergic reactions were excluded due to safety concerns. Additionally, there was a lack of racial diversity among the study’s participants.
“Peanut allergy can be very substantially reduced if peanut is introduced into the diet as early as 4 to 6 months of age,” Alkis Togias of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases wrote in an editorial published alongside the study. “Toddlers are of particular interest since their immune systems have plasticity that can theoretically allow for higher efficacy and longer-lasting benefits from allergen immunotherapy after therapy is discontinued.”
Togias also cited that skin patches may be less protective, but have a better safety profile compared to an oral medication, but still said that the findings, “are very good news for toddlers and their families as the next step toward a future with more treatments for food allergies.”