Peanut allergies: the skin patch shows promise in toddlers

CNN
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A ‘peanut patch’ showed promising results in a late-stage clinical trial in toddlers with peanut allergies, according to a new study.

Researchers from French biopharmaceutical company DBV Technologies and institutions around the world conducted a randomized, double-blind trial of the Viaskin Peanut patch in children aged 1 to 3 years who had been diagnosed with peanut allergy, they said. reported Wednesday in the New England Journal of Medicine.

The trial involved 362 toddlers from eight countries; 244 were randomly assigned to receive the Viaskin patch – which contains 250 micrograms of peanut protein, the equivalent of about 1/1000th of a peanut – and 118 received a placebo patch. They wore the patches between their shoulder blades daily for a year before being screened for peanut problems.

After 12 months, two-thirds of the children who used the Viaskin patch and one-third of the placebo group had reached the trial’s primary endpoint. Children with a less sensitive allergy could safely tolerate peanut protein equivalent to eating three or four peanuts, and children who were more sensitive could tolerate eating the equivalent of one peanut.

The researchers also noted “a shift towards less severe food challenge reactions” in the Viaskin group, DBV said in A press release.

Almost all of the young study participants experienced side effects, the most common being application site reactions such as redness, itching and swelling. Serious events were reported in 21 children who used the Viaskin patch and three in the placebo group.

During the study, a dangerous allergic reaction known as anaphylaxis was reported in 7.8% of Viaskin recipients and 3.4% of children who received the placebo. Only four of the reactions were considered treatment-related. Eight participants dropped out of the trial due to adverse events.

The researchers note that their study has several limitations, including that children with a history of severe allergic reactions were excluded for safety reasons and that there was a lack of racial diversity among the participants.

It’s estimated that 2.5% of American children may have peanut allergies, and only about 20% will eventually outgrow them. An oral treatment called Palforzia is approved for children ages 4 to 17 with peanut allergies, but there are no options available for younger children.

“Parents and caregivers eagerly await FDA-approved treatment options for this age group,” DBV CEO Daniel Tassé said in the press release.

The study’s lead author, Dr. Matthew Greenhawt of Colorado Children’s Hospital, said in the press release that the results were “significant progress.”

“I see peanut allergic patients daily in my clinical practice. I speak with parents who experience increased anxiety and reduced quality of life due to fear of life-threatening reactions,” he said. “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 have serious quality implications. of life.”

In an editorial published alongside the study, Dr. Alkis Togias of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases noted that “peanut allergy can be very significantly reduced if peanuts are introduced into the diet from 4 to 6 years. months of age. Health care providers around the world are now advising such an introduction, but there are questions about dosage, age, frequency and duration, he said.

“Toddlers are of particular interest because their immune systems have a plasticity that may theoretically allow for higher efficacy and longer lasting benefits of allergen immunotherapy after treatment is discontinued,” wrote Togias, who did not. not participated in the new research.

Compared to oral therapy, he said, skin patches may have less protective effect but a better safety profile.

Still, he said, the results of the Viaskin trial “are very good news for toddlers and their families as the next step toward a future with more treatments for food allergies.”