In a groundbreaking clinical trial, the monoclonal antibody omalizumab has been found to significantly reduce allergic reactions to multiple foods in children with food allergies. The study, which involved a 16-week course of treatment, demonstrated that nearly 67% of participants could consume a single dose of 600 milligrams (mg) or more of peanut protein—equivalent to about 2.5 peanuts—without experiencing a moderate or severe allergic reaction. This is a stark contrast to less than 7% of participants who received a placebo.
Key Findings:
- Omalizumab increased the threshold for allergic reactions to peanut, tree nuts, egg, milk, and wheat.
- The treatment was effective for children as young as 1 year old.
- Similar outcomes were observed for cashew, walnut, and hazelnut at a threshold dose of 1,000 mg protein or more.
This suggests that omalizumab could offer a significant protective measure for children and adolescents who accidentally consume foods they are allergic to, despite efforts to avoid them. The findings were presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting and published in The New England Journal of Medicine.
Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID), emphasized the stress and constant vigilance required by individuals with food allergies and their caregivers. She highlighted the importance of the findings, stating, "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."
The trial, known as OUtMATCH, is funded by NIAID with additional support from Genentech and Novartis Pharmaceuticals Corporation, which are collaborating to develop and promote omalizumab, marketed as Xolair. The study involved 177 children and adolescents aged 1 to 17 years and three adults aged 18 to 55 years, all with confirmed allergies to peanut and at least two other common foods.
How Omalizumab Works:
- It binds to the allergy-causing antibody immunoglobulin E (IgE) in the blood.
- Prevents IgE from arming key immune cells responsible for allergic reactions.
- Renders these cells much less sensitive to stimulation by any allergen.
Trial Outcomes:
- 66.9% of omalizumab-treated participants could consume at least 600 mg of peanut protein without a moderate or severe allergic reaction.
- Similar results were observed for milk, egg, cashew, wheat, walnut, and hazelnut at a threshold dose of 1,000 mg protein or more.
- Many participants could consume more than 600 mg of peanut protein, with some tolerating up to 6,044 mg, equivalent to about 25 peanuts.
Future Directions: The first 60 participants who completed the initial stage entered a 24-week open-label extension of omalizumab injections, with most maintaining or increasing the amount of food protein they could consume without an allergic reaction. Further information about the ongoing OUtMATCH trial is available at ClinicalTrials.gov under study identifier NCT03881696.
This research represents a significant step forward in the management of food allergies, offering hope to millions of children and their families for a safer and less stressful life.