Patched Up

Epicutaneous immunotherapy for peanut allergy has the potential to desensitize children ages 1 to 3 to peanuts as well as reduce allergic reactions to accidental exposure, says research published in The New England Journal of Medicine, co-authored by Le Bonheur Allergist/ Immunologist Jay Lieberman, MD.  

“The children who participated in this trial at our site all had excellent response and were all able to tolerate large amounts of peanut at the end of the study,” said Lieberman. “The hope with this patch, based on the results of this study, would be that very young children diagnosed with peanut allergy in the first couple years of life could use this patch to treat the allergy in a very safe way.”  

Currently, no approved treatment exists for peanut allergy in children younger than 4, but early peanut consumption can reduce the risks of severe allergic reactions while the immune system is still developing. The Viaskin patch, the medication tested in the EPITOPE trial, delivers 250 micrograms of peanut protein through a patch that is placed between the shoulders of the child daily for 12 months. The primary goal of the study was to desensitize the allergic children to peanuts, which was measured by an increase in the amount of peanut required to induce a reaction in the child.  

The study was held at 51 sites, including Le Bonheur, with a total of 350 patients — 233 receiving the intervention dose and 117 the placebo. Researchers measured how many patients in both groups reached a predetermined endpoint. The two endpoints measured were patients with a baseline eliciting dose of more than 10 mg of peanut protein and a post-treatment eliciting dose of at least 1000 mg of peanut protein (three to four peanuts) or a baseline eliciting dose of 10 mg or less and a post-treatment eliciting dose of at least 300 mg (one peanut).  

After 12 months, 67% of the intervention group and 33.5% of the placebo group met one of the two endpoints. In addition, the most severe allergic reaction symptoms had shifted to be less severe in the intervention group. At baseline, the mild, moderate and severe symptoms in the two groups were balanced. The most common adverse events were skin reactions at the site of the patch. Anaphylaxis occurred in 19 children in the intervention group (four of which were determined to be a result of the patch) and four in the placebo.  

The EPITOPE trial has now entered into a 24-month open label extension to continue following treatment response and determine the best duration for maximum treatment response. Le Bonheur will also participate in the VITESSE study, which will evaluate the Viaskin patch for children 4 to 7 years with peanut allergy. “Many new medications are being studied for peanut allergy, so we are hopeful that in the coming years, we will have more than one treatment option to offer families,” said Lieberman. “Le Bonheur will also be a site for future peanut allergy studies, so we are excited about that.” 

Le Bonheur Allergist/Immunologist Jay Lieberman, MD, was co-author on a study showing the efficacy of a patch-based medication to desensitize children ages 1 to 3 with peanut allergy. This medication has the potential to be the first peanut allergy treatment for children younger than 4 years.