In promising news for young toddlers with peanut allergies, a new study involving researchers from Children’s Hospital of Philadelphia (CHOP) found that daily use of a “peanut patch” for one year was effective in desensitizing a majority of peanut-allergic toddlers, lessening the likelihood of an allergic reaction upon accidental exposure. The findings were published today 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.”
Approximately 2% of children in the United States, Canada and other western countries suffer from peanut allergies. The allergy is a common cause of pediatric anaphylaxis, a rare but severe allergic reaction that can lead to death if untreated. The potential for such a severe reaction can lead to fear and psychosocial effects among patients and their families. Treatments that desensitize children to peanuts, so that an accidental exposure to a small amount of the allergen would not trigger an anaphylactic reaction, have the potential not only to make allergic children safer but also improve their quality of life.
Peanut oral immunotherapy (OIT) is available in non-commercialized forms for children under the age of 4, although it is not FDA approved. OIT can desensitize allergic children to peanuts by having them consume very small but increasing amounts of the allergen over time. However, OIT involves regular, demanding dosing schedules, side effects, as well as the small but possible risk of allergic reactions.
As an alternative, researchers have been investigating the use of epicutaneous immunotherapy (EPIT), which involves a patch containing a small amount of allergen that is placed on a child’s back, exposing the immune system to a very low level of allergen with much less risk of a systemic reaction. Other studies have shown this approach to be effective in children aged 4-11, but researchers wanted to establish the safety and efficacy of the product in toddlers aged 1-3.
In a phase 3 clinical trial, 362 patients between the ages of 1 and 3 were randomized into two groups: 244 received the peanut patch, and 118 received a placebo patch. The researchers set a baseline of how much peanut caused a reaction before treatment; 67 participants reacted to less than 10 mg of peanut and 295 reacted to more than 10 mg. Of note, one peanut contains 250 mg of peanut protein. The goal was to see if those with a lower baseline could tolerate approximately one peanut after 12 months of EPIT, changing the patch daily, and if those with a higher baseline could eventually tolerate approximately three to four peanuts.
After a year of treatment, a significantly larger percentage of those wearing the peanut patch were able to tolerate the required peanut dose – 67% of those wearing the interventional patch versus 33.5% of those wearing the placebo patch. In addition, 64.2% of those who were randomized into the peanut patch group could tolerate the equivalent of three to four peanuts, regardless of their baseline at the start of the trial. Although symptom severity was spread evenly across both groups at the start of the trial, the distribution shifted to less severe symptoms in the interventional group versus placebo by the end of the trial.
“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.”
Contact: Amanda DiPaolo Bradley, The Children’s Hospital of Philadelphia, or firstname.lastname@example.org