A recent clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) has demonstrated that omalizumab, a monoclonal antibody, can significantly reduce allergic reactions to multiple foods in children. The study, presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting and published in The New England Journal of Medicine, showed that a 16-week course of omalizumab increased the threshold for allergic reactions to peanut, tree nuts, egg, milk, and wheat in children as young as 1 year old. This suggests the drug's potential to protect against reactions from accidental exposure.
OUtMATCH Trial Results
The multi-stage trial, known as Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), enrolled 177 children and adolescents (ages 1-17) and three adults (ages 18-55) with confirmed allergies to peanut and at least two other common foods. Participants were randomized to receive either omalizumab or placebo injections for 16 to 20 weeks. Following the treatment period, participants underwent oral food challenges to assess their tolerance to various allergens.
The results indicated that 66.9% of omalizumab-treated children and adolescents could consume at least 600 mg of peanut protein without a moderate or severe allergic reaction, compared to only 6.8% in the placebo group. Similar results were observed for milk, egg, cashew, wheat, walnut, and hazelnut at a threshold dose of 1,000 mg protein or more. Many omalizumab-treated participants could tolerate even higher doses, with 67% consuming a cumulative dose of 1,044 mg of peanut protein (about four peanuts) and 44% consuming 6,044 mg (about 25 peanuts).
Clinical Implications and FDA Approval
"People with food allergies and their caregivers need to maintain constant vigilance to avoid foods that could cause a potentially life-threatening allergic reaction. This is extremely stressful, especially for parents of young children," said Jeanne Marrazzo, M.D., M.P.H., director of NIAID. "Although food avoidance remains critical, the findings reported today show that a medicine can help reduce the risk of allergic reactions to common foods and may provide protection from accidental exposure emergencies."
On February 16, 2024, the Food and Drug Administration (FDA) approved omalizumab for reducing allergic reactions, including anaphylaxis, from accidental exposure to one or more foods in adults and children aged 1 year and older with food allergy. This approval was based on data from an interim analysis of the Phase 3 NIAID trial. It is important to note that individuals taking omalizumab still need to avoid foods they are allergic to, as the drug is not approved for emergency treatment of allergic reactions.
Mechanism of Action
Omalizumab functions by binding to immunoglobulin E (IgE) in the blood, preventing it from activating immune cells responsible for allergic reactions. This reduces the sensitivity of these cells to allergens.
The OUtMATCH trial is ongoing at 10 locations across the United States, with further outcomes to be published in the future. The trial is funded by NIAID with additional support from Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation, who collaborate to develop and promote omalizumab (Xolair).
