ATLANTA (January 10, 2019) - Children’s Healthcare of Atlanta, in collaboration with its research partner Emory University, was recently selected as an OUtMATCH clinical trial site to test whether omalizumab, an FDA-approved treatment for asthma, could be effective at protecting patients with multiple food allergies.
There is currently no FDA-approved treatment to reduce food allergy risk, which affects an estimated eight percent of children in the U.S. Anyone with an allergy must carefully avoid exposure, and those experiencing multiple food allergies are more likely to consume a food allergen accidentally, increasing their risk for a life-threatening adverse reaction.
“This study will be the largest trial to tackle the major unmet medical need associated with multiple food allergies, which affect 30 to 40 percent of food allergy patients,” said Brian Vickery, M.D., principal investigator for OUtMATCH at Children’s and associate professor at the Emory University School of Medicine.
Food allergies occur when the immune system reacts abnormally to certain foods, sometimes producing a severe response called anaphylaxis, which can be deadly. Often, rescue medications like epinephrine are used during a reaction, but there is no approved treatment to help stop reactions from occurring in the first place.
“Emergency room visits for food anaphylaxis nearly quadrupled in the U.S. from 2007 to 2016,” said Vickery, who also serves as director of the Food Allergy Program at Children’s. “Almost 30,000 patients will experience a reaction requiring an emergency room visit each year.”
OUtMATCH is an abbreviation for “Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults,” the name of the study. The five-year trial, taking place at 10 sites nationwide, will test omalizumab injections in 225 children and adults ages 2 to 56, but most sites will primarily study children. Vickery and his team will enroll 20 to 25 participants up to age 21 with a peanut allergy and at least two other food allergies, including cow’s milk, egg white, wheat, cashew, hazelnut or walnut. They will test omalizumab alone and in combination with oral immunotherapy, a method for gradually introducing food that causes an allergic reaction. The final stage of the trial will focus on individualizing treatment regimens.
The research is sponsored by the National Institute of Allergy and Infectious Disease of the National Institutes of Health and will be administered through the Consortium of Food Allergy Research. Children’s was approved to begin enrolling patients on October 30. To learn more, visit www.choa.org/foodallergy.