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A “peanut patch” showed promising results in a late-phase clinical trial in young children with peanut allergies, according to a new study.
Researchers at French biopharmaceutical firm DBV Technologies and institutions around the world conducted a randomized, double-blind trial of the Viaskin Peanut patch in children ages 1 to 3 who had been diagnosed with a peanut allergy, they reported Wednesday in The New England Journal. of Medication.
The trial involved 362 young children from eight countries; 244 were randomly assigned to receive the Viaskin patch, which contains 250 micrograms of peanut protein, the equivalent of about 1/1000 of a peanut, and 118 received a placebo patch. They wore the patches between their shoulder blades daily for a year before being tested for peanut challenges.
After 12 months, two-thirds of the children using the Viaskin patch and one-third of the placebo group had achieved the trial’s primary endpoint. Children with a less sensitive allergy could safely tolerate the equivalent of eating three or four peanuts in peanut protein, and children who were more sensitive could tolerate the equivalent of eating one peanut.
The researchers also noted “a shift toward less severe food challenge reactions” in the Viaskin group, DBV said in a press release.
Almost all of the young study participants had adverse events, the most common being application site reactions such as redness, itching and swelling. Serious events were reported in 21 children using the Viaskin patch and three in the placebo group.
Over the course of the study, a dangerous allergic reaction known as anaphylaxis was reported in 7.8% of those who received Viaskin and 3.4% of children who received the placebo. Only four of the reactions were considered related to treatment. Eight participants withdrew from 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 is 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 are eagerly awaiting 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 Children’s Hospital of Colorado, said in the news release that the findings are a “significant advance.”
“I see peanut-allergic patients in my clinical practice every day. I speak to parents who are experiencing increased anxiety and decreased quality of life due to fear of life-threatening reactions,” she said. “The Viaskin Peanut patch has the potential to bring new hope to young children and their families who currently have no approved treatment options and must rely on avoiding them, which can severely impact quality of life.”
In an editorial Published in conjunction with the study, Dr. Alkis Togias, of the National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology, and Transplantation, noted that “peanut allergy can be substantially reduced if peanuts are introduced into the diet as early as soon as 4 to 6 months of age.” Health care providers around the world now recommend such an introduction, but there are questions about dosage, age, frequency and duration, he said.
“Young children are of particular interest as their immune systems have a plasticity that may theoretically allow greater efficacy and longer lasting benefits of allergen immunotherapy after therapy is discontinued,” wrote Togias, who was not involved in the new study. investigation.
Compared with oral therapy, he said, skin patches may have less protective effect but a better safety profile.
Still, he said, the Viaskin trial findings “are very good news for young children and their families as the next step toward a future of more food allergy treatments.”
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