Controlled ingestion of peanut protein could help build tolerance in peanut allergy sufferers, according to a new study published in the New England Journal of Medicine. The oral immunotherapy drug, called AR101, is derived from peanut protein.
“The results of this landmark trial are likely to lead to the first FDA-approved treatment for food allergy in 2019,” says Christina E. Ciaccio, MD, MSc, associate professor of pediatrics and medicine at the University of Chicago Medicine Comer Children's Hospital and study co-author. “At UChicago Medicine Comer Children’s Hospital, we were thrilled to be part of this pivotal trial and for the opportunity to change the lives of these children and their families.”
Researchers in 10 countries across North America and Europe conducted the trial, known as the Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization trial (PALISADE). Of 496 eligible participants ages four to 17 years old, 372 received the AR101 oral medication, while the remainder received a placebo drug. At the end of the trial, more than two thirds of the group taking the active drug were able to tolerate a dose of peanut protein equivalent to about two peanut kernels.
“Almost six million American children are currently living with a life-threatening food allergy,” says Ciaccio. “Every three minutes, a food allergy reaction sends someone to the emergency room, contributing to the total annual cost of caring for children with food allergy of nearly $25 billion. Despite this, not a single treatment for food allergy has been approved by the FDA.”
According to the study, oral immunotherapy for peanut allergy has been recommended against in most clinical settings because past trials have been limited by small sample sizes and differing methodologies. The PALISADE trial has shown, however, that oral immunotherapy can be a successful treatment option. Participants of the PALISADE trial were instructed to continue the standard of care for peanut allergy, which meant eliminating peanuts from their diets and carrying self-injectable epinephrine (an emergency medical treatment for accidental exposure).
Now, we can provide a safety net to kids that will prevent an allergic reaction if they accidentally take a bite of a peanut-containing food.
Christina E. Ciaccio, MD, MSc
Qualifying participants started with a one-day supervised increase in dosage from 0.5 mg of peanut protein up to 6 mg, an increase every two weeks from 3 mg to 240 mg, and a 24-week “maintenance phase” at 300 mg. When adverse reactions occurred, the study protocol allowed for adjustments to the dosing schedule. Compared to the placebo group, participants who took AR101 had less severe allergy symptoms.
“Before this treatment, families were living with constant anxiety that one wrong bite would send their loved one to the emergency room, or worse,” says Ciaccio. “Now, we can provide a safety net to kids that will prevent an allergic reaction if they accidentally take a bite of a peanut-containing food.”
The study was funded by Aimmune Therapeutics, Inc. and can be found here.
Asthma is hurting children on Chicago's South Side. In some South Side neighborhoods, up to 59 percent of kids have the dangerous respiratory condition — compared with a rate of only nine percent across the United States.
Health leaders in the area are fighting to do something about it. The University of Chicago Medicine's Urban Health Initiative and Comer Children’s Hospital are leading a collaboration of health providers to develop the South Side Pediatric Asthma Center. The objective of the center is to create and advance an innovative and high-quality system of care for pediatric asthma management on the South Side.
Through the South Side Pediatric Asthma Center, UChicago Medicine and partner institutions have adopted a pediatric asthma management model to standardize patient education, establish one-stop asthma care on the South Side, support asthma care in the community through community health workers, and host provider and community education events.