A groundbreaking clinical trial sponsored and funded by the National Institutes of Health (NIH) and conducted in part at Arkansas Children's Hospital (ACH) unveiled a pioneering treatment helping children and adults with potentially life-threatening food allergies better tolerate peanut, milk, egg, wheat, and tree nuts.
The Phase 3 OUtMATCH study is published in The New England Journal of Medicine, a week after the Food and Drug Administration issued approval for omalizumab to treat multiple food allergies. It is considered the first and only medicine for children and adults with one or more food allergies.
Stacie Jones, MD, who treats allergy patients at ACH, serves as the principal investigator at Arkansas Children’s Research Institute (ACRI), one of 10 sites in the U.S. conducting the OUtMATCH study through the Consortium for Food Allergy Research. She is also a professor of pediatric allergy and immunology in the University of Arkansas for Medical Science (UAMS) College of Medicine.
“We estimate that 40% of the millions of people in the United States who cope with food allergies are allergic to multiple foods,” Jones said. “This treatment will have a tremendous impact on their quality of life. It will mean they live with less fear of an allergic reaction. This heralds an era of hope and possibility as we move toward more solutions for patients and families living with food allergy.”
The study examined 177 children and adolescents, as well as three adults, as they took injections every two to four weeks over four to five months. All the patients were allergic to peanuts and at least two other foods.
The study found that omalizumab, a monoclonal antibody, reduces allergic reactions in children and adolescents if they accidentally eat a food to which they are allergic despite efforts to avoid it. Nearly 67% of study participants who received omalizumab could eat the equivalent of 2.5 peanuts without a moderate or severe allergic reaction, compared to less than 7% of those who received a placebo. The researchers observed similar outcomes for study participants allergic to milk, egg, walnut, wheat, cashew, and hazelnut.
Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation collaborate to develop and co-promote omalizumab, marketed as Xolair, and supply it for the OUtMATCH trial.
On Feb. 16, the FDA approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. Omalizumab is not approved for the emergency treatment of allergic reactions, including anaphylaxis. People taking omalizumab for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).
Omalizumab was previously FDA-approved and prescribed at Arkansas Children’s for asthma and chronic hives. This treatment will be available for qualifying food allergy patients immediately.
This marks the second drug approved by the FDA to help people with food allergies studied by the Arkansas Children’s Food Allergy Program and their collaborators. The NIH Consortium for Food Allergy Research (CoFAR) was formed in 2005 with the Arkansas Children’s Food Allergy Program being an inaugural member. Palforzia, also studied in a clinical trial at ACH, was approved by the FDA in 2020.
“The Consortium for Food Allergy Research allows us to draw on the expertise of food allergy centers across the nation, and we partner to produce transformative outcomes for patients and families as quickly as we can,” Jones said. “The study participants in Arkansas and across the other nine sites are the reason we can move these treatments forward and see the immediate impact of collaborative research.”
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the regulatory sponsor of the OUtMATCH trial. NIAID funds the ongoing trial with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation.
The National Center for Advancing Translational Sciences (NCATS), also part of NIH, supports some of the staff, space and services used to conduct the trial.
The research described in this press release was funded by NIAID and NCATS under award numbers UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004408, UM1AI130570, UM1AI130839, UM1AI130936, UL1TR002535, UM1TR004399, UL1TR001878, UM1AI130781, and UL1TR002378.