ATLANTA (Nov 18, 2018) – A new study published today in the New England Journal of Medicine could lead to therapeutic treatment options for children and adolescents allergic to peanuts. Brian Vickery, MD, Director, Food Allergy Program, Children’s Healthcare of Atlanta led an international Phase 3 clinical trial studying AR101, an investigational medicine developed by Aimmune Therapeutics. The results of the trial, conducted prior to Dr. Vickery joining Children’s, show that children and adolescents highly allergic to peanuts who received active treatments of AR101 were able to tolerate higher doses of the allergen and experienced reduced symptom severity during exposure.
“Studies like this one break new ground in our understanding of peanut allergies among children,” says Dr. Vickery. “This was the largest clinical trial ever conducted in food immunotherapy, and the results suggest that the treatment could potentially protect peanut-allergic children from severe reactions due to accidental exposures, which would be life-changing for families. We are excited to be able to conduct research that could one day lead to new treatment options that improve the lives of families dealing with peanut allergies.”
There are currently no FDA approved treatment options for patients with peanut allergies, who are at risk of unpredictable and occasionally life-threatening allergic reactions. Historical recommendations for managing food allergies have been limited to advising patients to eliminate the allergen from the diet, as well as timely administration of rescue medications in the case of an accident. For the first time, the study’s AR101 treatment could replace that approach with an active form of immunotherapy, if approved by the FDA.
The randomized, double-blind, placebo-controlled study published today was conducted at 66 sites in 10 countries and examined 554 participants’ reactions to peanut exposure before and after receiving the AR101 treatment. The primary analysis was conducted in the 496 pediatric participants aged four to 17 years old, all of whom had allergic reactions to 100 mg of peanut protein (one-third of one peanut) or less prior to treatment.
After approximately one year of treatment, 67 percent of those receiving active treatment could successfully consume at least 600 mg of peanut protein (approximately two peanuts), compared to four percent in the placebo group. Treatment also resulted in a reduction in symptom severity during peanut exposure.
Adverse events were common in both active and placebo groups, and most were mild or moderate. However, the participants receiving active treatment more frequently experienced systemic allergic reactions to the treatment and withdrawal from the study, compared to the placebo group.
“Dr. Vickery’s important work to discover treatments for food allergies could be life altering not only for patients here at Children’s, but children nationwide,” said Lucky Jain, MD, and Chief Academic Officer of Children’s Healthcare of Atlanta. “His visionary leadership and expert knowledge of pediatric food allergies is essential in guiding our program to becoming a national leader in the study and treatment of food allergies.”
It is now estimated that eight percent of children in the United States are affected by food allergies. Noting the increasing number of kids affected, Children’s, in collaboration with research partner Emory University, launched the Food Allergy Program in early 2018. The program is housed in the new Children’s Healthcare of Atlanta Center for Advanced Pediatrics and features on-site research units. Building a robust clinical research program is critical in our continued effort to learn more about food allergies and develop new treatments for all food allergies, not only peanut. Based on the results of this study, Dr. Vickery plans to conduct additional research at the Center for Advanced Pediatrics.
Dr. Vickery, who is also a pediatric allergist and immunologist at Children’s and associate professor of pediatrics at Emory University School of Medicine, led this clinical study while employed by Aimmune Therapeutics. While he does have a consulting agreement in place, he is no longer employed by the company, and he does not have a financial stake in the results of the research.