A study recently published in the New England Journal of Medicine found that a 16-week course of treatment with omalizumab increased the amount of peanut, tree nuts, egg, milk and wheat that children as young as 1 year old with multi-food allergies could consume without an allergic reaction. Children's Hospital of Philadelphia (CHOP) served as one of the clinical trial sites that led to the FDA approval of omalizumab for people with food allergy.
The study found that nearly 67% of study participants who completed treatment with omalizumab could consume a single dose of 600 mg or more of peanut protein (about 2.5 peanuts) without experiencing a moderate or severe allergic reaction, compared with less than 7% of participants who received the placebo. Similar outcomes were seen for the consumption of egg, milk, wheat, cashew, walnut and hazelnut, with a threshold of 1,000 mg of protein or more.
While omalizumab will not cure food allergies, the study suggests that the medication, which has been approved by the FDA since 2003 to treat moderate to severe persistent allergic asthma in certain individuals, has the potential to protect children and adolescents if they accidentally eat a food that contains one of these allergens despite efforts to avoid them.
"Accidental exposure to a food allergen is one of the most common concerns among parents of children with food allergies, so this medication provides families with an additional option to help reduce the impact of an allergic reaction," said Jonathan Spergel, MD, PhD, Chief of the Allergy Program at CHOP and co-author on the study.
On February 16, 2024, the Food and Drug Administration approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adults and children aged 1 year and older with food allergy. The FDA approval was based on data from a planned interim analysis of the OUtMATCH clinical trial. People taking omalizumab still need to avoid foods they are allergic to. Omalizumab is not approved for the emergency treatment of allergic reactions, including anaphylaxis.
The OUtMATCH trial is funded by NIAID and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health, under award numbers UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004408, UM1AI130570, UM1AI130839, UM1AI130936, UM1TR004406, UL1TR002535, UM1TR004399, UL1TR001878, UM1AI130781, UL1TR002378, and UL1TR003107.
