After 1 year of wearing a peanut patch as immunotherapy for their peanut allergy, 35% of participating children (aged 4 to 11 years) were able to tolerate a significantly higher dose of peanuts before experiencing an allergic reaction, according to results from an international, phase 3 randomized clinical trial published in the Journal of the American Medical Association (JAMA). The peanut patch had a favorable safety profile.

The study used two definitions of responders to the peanut patch. One group of responders increased their symptom-eliciting dose, from 1/30th of a peanut or less at the start of the study, to one peanut or more after 12 months with the peanut patch. The second group of responders increased their eliciting dose from over 1/30th of a peanut and up to one peanut at baseline, to over three peanuts (at least 1,000 mg) after 12 months of immunotherapy. In a supplemental analysis, when such stringent criteria were not used, 62% of children who wore the peanut patch increased their eliciting dose after 12 months.

“The positive results are reassuring, suggesting that the peanut patch could reduce severe allergic reactions from accidental exposure to small amounts of peanut, as might be the case when a product is made on shared equipment with peanuts,” says study author Jacqueline Pongracic, MD, head of allergy and immunology at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics at Northwestern University Feinberg School of Medicine. “While not a cure, this kind of protection would make a huge difference in the lives of children with peanut allergy.”

Peanut allergy is the most common food allergy in the United States, affecting over 1.6 million children, and it accounts for the majority of deaths related to food allergy. Currently, there are no approved treatments. The standard of care is strict elimination diet and timely administration of rescue medications in case of an allergic reaction from accidental exposure.

In the study, systemic allergic reactions to the peanut patch were rare and none were severe. The patch was mostly associated with mild redness and swelling at the site of application, an effect that tended to resolve over a few months. Treatment adherence was high (over 98%).

“It is possible that we will see higher response rates to the peanut patch after children wear it for a longer period of time,” says Dr. Pongracic. An earlier phase 2 trial showed a response rate of 68% after 3 years of wearing the peanut patch in children 6 to 11 years of age. Dr. Pongracic and colleagues currently are conducting an extension study to determine if efficacy improves with more time in children 4 to 11 years of age.

The phase 3 study was sponsored by DBV Technologies and conducted under an investigational new drug application to the US FDA and clinical trial approvals in Canada and European countries.