A recent clinical trial has demonstrated that omalizumab, marketed as Xolair, is more effective than oral immunotherapy (OIT) in treating multi-food allergy, particularly in individuals with severe allergic reactions to very small amounts of common food allergens. The study found that a significant proportion of participants who received omalizumab could tolerate larger amounts of multiple allergens, compared to those who received OIT, the most common treatment for food allergies in the United States.
Key Findings
In this study, 36% of participants who received an extended course of omalizumab were able to tolerate at least 2 grams of peanut protein (equivalent to about eight peanuts) and two other allergens by the end of the treatment period. In contrast, only 19% of participants who underwent multi-food OIT reached this threshold.
The researchers attributed the superior results of omalizumab to a higher rate of allergic reactions and intolerable side effects seen in the OIT group. These issues led to a quarter of OIT-treated participants discontinuing therapy. When the analysis excluded those who discontinued, however, both treatment groups showed similar results, with the same proportion able to tolerate 2 grams of all three allergens.
This study, published in an online supplement of The Journal of Allergy and Clinical Immunology, was also presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress in San Diego on March 2, 2025.
Omalizumab’s Mechanism of Action
Omalizumab works by binding to immunoglobulin E (IgE), an antibody responsible for allergic reactions. By preventing IgE from activating immune cells, omalizumab significantly reduces the immune system’s sensitivity to allergens. This helps mitigate the allergic response and allows individuals to tolerate greater amounts of food allergens without experiencing severe reactions.
Trial Design and Results
The clinical trial, called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), was conducted at 10 locations across the United States. The trial involved 177 children and adolescents aged 1 to 17 years, and three adults aged 18 to 55 years, all of whom had confirmed allergies to small amounts of common allergens like peanut, milk, egg, cashew, wheat, hazelnut, or walnut.
After completing the first stage of the trial, 117 participants entered the second stage. In this stage, all participants received omalizumab injections for eight weeks. They were then randomly divided into two groups. Group A received both omalizumab injections and multi-food OIT, while Group B received omalizumab injections with placebo OIT. The treatment period for both groups lasted 52 weeks, with participants in Group A receiving OIT during the initial months alongside omalizumab injections.
Despite the use of omalizumab in the early phase of OIT to enhance safety, 29 out of 59 participants in Group A discontinued the therapy, largely due to allergic reactions or intolerable side effects related to OIT. On the other hand, no participants in Group B experienced side effects from omalizumab that led to discontinuation, though seven dropped out for other reasons, such as the burden of the study. Ultimately, 30 participants from Group A (51%) and 51 participants from Group B (88%) completed the treatment period.
Treatment Outcomes
After the trial period, participants were tested for their ability to consume at least 2 grams of peanut protein and two other allergens without experiencing an allergic reaction. Among participants who completed the therapy, 36% of Group B (the omalizumab-only group) were able to tolerate 2 grams of all three allergens, while 19% of Group A (the OIT group) reached the same threshold. These findings confirm that omalizumab was more effective than OIT at treating multi-food allergies in participants with initially low tolerance to common allergens.
Significance of the Study
Dr. Jeanne Marrazzo, M.D., M.P.H., director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the study’s funder, emphasized that omalizumab is a promising alternative for people with multi-food allergies, especially for those who cannot tolerate the side effects associated with OIT. While oral immunotherapy remains a viable option for some, omalizumab offers a safer, more tolerable solution for many patients, making it an important alternative for treatment.
Ongoing Research and Funding
This trial is part of a broader, ongoing investigation into omalizumab’s effectiveness in treating multi-food allergies. The research is funded by NIAID, with additional financial support from Genentech (a member of the Roche Group) and Novartis Pharmaceuticals Corporation, both of which supply omalizumab for the study.
The study is being conducted under the leadership of Robert Wood, M.D., and R. Sharon Chinthrajah, M.D., with collaboration from the Consortium for Food Allergy Research (CoFAR) and other academic institutions. These findings provide hope for a new, more effective treatment approach for individuals with multi-food allergies, potentially transforming the landscape of food allergy treatment in the years to come.
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