A recent study has shown promising results in the treatment of peanut allergies in toddlers.
The Viaskin Patch, developed by French biopharmaceutical firm DBV Technologies, was tested in a randomized double-blind trial on 362 children aged 1 through 3 who had been diagnosed with a peanut allergy.
The results, published in The New England Journal of Medicine, revealed that after wearing the patch for a year, two-thirds of the children who used it could safely tolerate peanut protein, while only one-third of the placebo group could do so.
Lead researcher Dr. Matthew Greenhawt of Children's Hospital Colorado said the findings are a meaningful advancement that 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.
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Throughout the study, a dangerous allergic reaction known as anaphylaxis was reported in 7.8% of Viaskin recipients and 3.4% of children who got the placebo. Only four of the reactions were deemed to be related to treatment, indicating that the Viaskin Patch offers a safer treatment option for peanut allergies in toddlers.
DBV Technologies CEO Daniel Tassé said that parents and caregivers eagerly await FDA-approved treatment options for this age group, as an estimated 2.5% of US children may have peanut allergies, and only about 20% will eventually outgrow them, according to the Associated Press.
While an oral treatment called Palforzia is approved for 4- to 17-year-olds with peanut allergies, there are no available options for younger children.
Application-site reactions were the most common adverse events reported among the young study participants. Nearly all of them had adverse events, with 21 children who used the Viaskin Patch reporting serious events and three in the placebo group reporting serious events.
The researchers, however, noted "a shift towards less severe food challenge reactions" in the Viaskin group, according to a DBV news release.
Limitations of the Viaskin Patch
According to CNN, the 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 also important to note that the study was funded by DBV Technologies and several of the researchers involved in the trial were employees of the company.
The study's primary endpoint was met by 66% of the children who used the Viaskin Patch, which features 250 micrograms of peanut protein, equivalent to about 1/1000th of one peanut, while only 33% of the placebo group met the endpoint.
Kids with mild allergies could handle peanut protein that is equal to having three to four peanuts, while those with more severe allergies could tolerate the same amount of protein as eating one peanut, without experiencing any adverse effects.
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Introducing Peanuts Early Can Help Reduce Allergy
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 introducing peanuts into a child's diet as early as 4 to 6 months of age can substantially reduce peanut allergy.
Healthcare providers around the world now advise such an introduction, but there are still questions about dosage, age, frequency, and duration, he said.
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 wrote in the editorial.