12 Months of Treatment with EPIT Superior to Placebo in Desensitizing Children to Peanuts
This multi-site clinical trial was conducted in part at the NC TraCS Clinical and Translational Research Center (CTRC).
The study, called EPITOPE, led by senior author A. Wesley Burks, MD, CEO of UNC Health and dean of the UNC School of Medicine, and contributing author Edwin Kim, MD, MS, associate professor of pediatrics in the Division of Pediatric Allergy and Immunology at the UNC School of Medicine, shows superior results in desensitizing children to peanuts. Results were recently published in the New England Journal of Medicine.
Peanut allergy affects approximately two percent of children in the United States, Canada, and other westernized countries, with a rapidly rising prevalence over the past 20 years. Currently there are no FDA approved treatment options for peanut-allergic children under the age of 4 years, but further research into the safety, efficacy, and tolerability of epicutaneous immunotherapy (EPIT) could play a significant role in novel options for immunotherapy.
The EPITOPE trial, led by senior author A. Wesley Burks, MD, CEO of UNC Health and dean of the UNC School of Medicine, evaluating the safety profile of Viaskin, a novel form of EPIT, among peanut-allergic toddlers shows that after 12 months of treatment in children aged 1-3 years, the treatment was found to be statistically superior to placebo in desensitizing participants to peanuts, increasing the peanut dose triggering allergic symptoms. Edwin Kim, MD, MS, associate professor of pediatrics in the Division of Pediatric Allergy and Immunology at the UNC School of Medicine is also a contributing author to the paper.
"These are very encouraging results and move us closer to a treatment option for this increasingly prevalent and serious allergic condition," said Burks. "We hope this will be available to patients in the not too distant future."
"With feeding guidelines now recommending the introduction of peanut in the first year of life, we are diagnosing peanut allergy earlier and earlier,” said Kim. “The EPITOPE trial shows that the Viaskin peanut patch may not only be an effective treatment option but importantly a simple and safe option in this very young age group.”
Published in the New England Journal of Medicine, results showed that more than one-third (37-percent) of Viaskin Peanut-treated participants in the EPITOPE trial, sponsored by DBV Technologies, a clinical-stage biopharmaceutical company, reached a cumulative reactive dose ≥3444 mg. Viaskin, a patch-based non-oral immunotherapy, is a potential new class of treatment that harnesses the immune properties of the skin. It has the potential to help modify individuals' underlying food allergy by desensitizing the immune system to an allergen. Viaskin Peanut is currently under clinical investigation and is not yet approved by the U.S. Food and Drug Administration or any other regulatory agencies. If approved, Viaskin Peanut would provide an additional treatment option to offer patients and families for whom the standard of care alone—allergen avoidance and use of rescue medication—may not be enough.
EPITOPE was a Phase 3, randomized, double-blind, placebo-controlled trial designed to allow participants to go about their normal daily activities without restrictions. After one year of treatment, Viaskin Peanut resulted in statistically superior desensitization compared with placebo, with treatment responder rates of 67.0% and 33.5%, respectively. Additionally, a shift towards less severe food challenge reactions was seen following 12 months of treatment. Similar to previous studies of Viaskin Peanut in children, the most common adverse events (AEs) were local application site reactions, which decreased in frequency and severity over time. Low rates of treatment-related anaphylaxis and epinephrine use were observed. This study demonstrated that 12 months of daily EPIT with a patch containing 250 µg peanut protein (1/1000th of one peanut) was sufficient to decrease the likelihood of experiencing an allergic reaction following accidental peanut exposure. Viaskin Peanut was well-tolerated by a majority of participants and had low discontinuations due to AEs and high compliance rates.
Originally published at news.unchealthcare.org.