Researchers at Children’s Healthcare of Atlanta recently participated in the international, multicenter, Phase 3 EPITOPE trial to determine the safety and efficacy of epicutaneous, meaning “on the skin”, immunotherapy (EPIT) for children ages one to three years of who have been diagnosed with peanut allergy.
Brian Vickery, MD, Director of the Food Allergy Program at Children’s, is a co-author of this publication in the New England Journal of Medicine, having participated as a site Principal Investigator in this global study. The results show that 12 months of treatment with DBV Technologies’ Viaskin™ Peanut patch desensitized toddlers to peanuts, decreasing the chance of experiencing an allergic reaction after an accidental peanut exposure.
“This new treatment approach could be a game-changer for young children suffering from peanut allergies, if it were to become approved for clinical use,” said Dr. Vickery. “Because the patch dose is given on the skin and not as a shot or an oral treatment, the risks are low, and the approach is very patient-friendly. Families of young peanut-allergic children currently have no treatment options, and often struggle with keeping their children safe during routine daily activities. If approved, EPIT may help them feel safer going about their normal daily activities and hopefully improve quality of life.”
After one year of treatment, Viaskin Peanut was superior to placebo in desensitization, with treatment responder rates of 67.0% and 33.5%, respectively. Additionally, less severe food challenge reactions were seen following 12 months of treatment. Similar to previous studies of Viaskin Peanut in children, the most common side effects were local skin reactions, which decreased in frequency and severity over time. Low rates of treatment-related anaphylaxis and epinephrine use were observed.
Viaskin Peanut is currently under clinical investigation but has the potential to help modify young children’s food allergy by desensitizing the immune system to an allergen and would provide an additional treatment option for young patients and their families. There are currently no FDA approved treatment options for peanut-allergic children under four years of age.