Peanut Patch Desensitized Peanut Allergic Children

A new study involving Children’s Hospital of Philadelphia (CHOP) researchers found that daily use of a “peanut patch” for one year was effective in desensitizing a majority of peanut-allergic toddlers, reducing the likelihood of an allergic reaction upon accidental exposure. The research was published in the New England Journal of Medicine.

“Currently there are no FDA-approved peanut allergy treatments for patients under the age of 4, so this study is exciting news,” said study co-author Terri F. Brown-Whitehorn, MD, an attending physician in the Division of Allergy and Immunology and site Principal Investigator. “Although an allergy patch won’t necessarily work for all toddlers, this study shows that it could be one more tool in an allergist’s toolbox to help prevent a life-threatening allergic reaction.”

Peanut allergies affect approximately 2% of children in the United States, Canada, and other Western countries. The allergy is a significant cause of pediatric anaphylaxis, a rare but severe allergic reaction that, if left untreated, can result in death. The possibility of such a severe reaction might cause anxiety and emotional repercussions in patients and their family. Treatments that desensitize children to peanuts, such that an accidental exposure to a small amount of the allergen does not result in an anaphylactic reaction, have the potential to not only make allergic children safer, but also to improve their quality of life.

Peanut oral immunotherapy (OIT) is available for children under the age of four in non-commercialized forms, although it is not FDA approved. OIT can desensitize allergic youngsters to peanuts by consuming extremely little amounts of the allergen over time. However, OIT entails strict dose regimens, side effects, and the modest but probable risk of allergic responses.

Researchers have been looking into the use of epicutaneous immunotherapy (EPIT), which entails placing a patch with a small quantity of allergen on a child’s back, exposing the immune system to a very low dose of allergen with a considerably lower risk of a systemic reaction. Other trials have demonstrated that this strategy is helpful in children aged 4-11, but researchers intended to establish the product’s safety and efficacy in toddlers aged 1-3.

In a phase 3 clinical trial, 362 patients aged 1 to 3 were randomly assigned to one of two groups: 244 received the peanut patch and 118 received a placebo patch. Before treatment, the researchers established a baseline for how much peanut caused a reaction; 67 people reacted to less than 10 mg of peanut and 295 reacted to more than 10 mg. It is worth noting that one peanut has 250 mg of peanut protein. The goal was to test if those with a lower baseline could tolerate one peanut after a year of EPIT, replacing the patch every day, and if those with a higher baseline could eventually tolerate three to four peanuts.

After a year of treatment, 67% of those wearing the interventional patch were able to tolerate the recommended peanut dose, compared to 33.5% of those wearing the placebo patch. Furthermore, regardless of their baseline at the outset of the experiment, 64.2% of those randomized into the peanut patch group could tolerate the equivalent of three to four peanuts. Although symptom severity was distributed evenly among both groups at the start of the study, at the end of the experiment, the distribution switched to fewer severe symptoms in the interventional group than placebo.

“It is so exciting to see how successful this study has been for many of our patients here at CHOP,” said Courtney Rooney, RN, BSN, lead research nurse and coordinator of all epicutaneous studies performed at CHOP. “The most rewarding part is seeing how grateful these patients and families are.”

“This study builds upon years of research we have done at CHOP trying to expand the options available to those with severe food allergies,” Dr. Brown-Whitehorn said. “We hope the data in this study not only eventually leads to an FDA approval of this product but also provides of a proof of concept for other life-threatening food allergies beyond those involving peanuts.”

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