Omalizumab outperforms oral immunotherapy in treating multi-food allergy

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A new clinical trial has found that omalizumab (Xolair; Genetech, Novartis) is more effective than oral immunotherapy (OIT) in treating multi-food allergy in individuals with severe allergic reactions to small amounts of common food allergens.^1,2

The trial demonstrated that 36% of participants who received an extended course of omalizumab could tolerate at least 2g of peanut protein—equivalent to about 8 peanuts—and 2 other food allergens, compared to 19% of participants who received multi-food OIT. The lower success rate for OIT was largely attributed to the high rate of allergic reactions and other intolerable side effects, which led a quarter of OIT participants to discontinue treatment.

When accounting only for participants who completed therapy, both treatment groups had the same proportion of individuals able to tolerate at least 2g of all 3 food allergens.

“People with highly sensitive multi-food allergy previously had only one treatment option—oral immunotherapy—for reducing their allergic response to moderate amounts of those foods,” said Jeanne Marrazzo, MD, MPH, director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which funded and sponsored the study. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.”

Omalizumab works by binding to immunoglobulin E (IgE), the antibody responsible for allergic reactions, thereby reducing immune cell sensitivity to allergens. The study is the second stage of an ongoing clinical trial, OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults), conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR).

The trial enrolled 177 children and adolescents (ages 1 to 17) and 3 adults (ages 18 to 55) across 10 locations in the United States. Participants were confirmed to have severe allergies to less than half a peanut and similarly small amounts of at least 2 other common allergens, including milk, egg, cashew, wheat, hazelnut, or walnut. After completing an initial 16-week omalizumab treatment phase, 117 individuals entered the second stage of the trial.

Participants were randomly assigned to 1 of 2 groups: 1 receiving omalizumab injections and multi-allergen OIT for 8 weeks, followed by placebo injections and continued OIT for 44 weeks; and the other receiving omalizumab injections and placebo OIT for the full treatment period. The study was double-blinded, meaning neither participants nor investigators knew who was in each group.

High rates of allergic reactions were observed among those undergoing OIT, leading 29 of 59 participants in the OIT-treated group to discontinue therapy.

Of these, 15 withdrew due to severe allergic reactions or other intolerable symptoms, while 14 left for other reasons such as aversion to the study foods or the trial's demands.

In contrast, none of the participants receiving only omalizumab experienced allergic reactions severe enough to discontinue treatment, though 7 left the study primarily due to its logistical burden.

By the end of the treatment period, 51% of the OIT-treated group and 88% of the omalizumab-only group completed therapy. Among all participants, 36% of those receiving omalizumab could consume at least 2g of their 3 allergens without reaction, compared to 19% in the OIT group. However, when considering only those who completed therapy, the success rate was the same for both groups.

Disclosure:

The trial received funding from NIAID, with additional support from Genentech and Novartis Pharmaceuticals Corporation, which collaborated on the development of omalizumab and supplied the medication for the study.

References

1. National Institute of Allergy and Infectious Diseases. Omalizumab treats multi-food allergy better than oral immunotherapy. Eurekalert. March 2, 2025. Accessed March 26, 2025. https://www.eurekalert.org/news-releases/1075094

2. RA Wood et al. Treatment of multi-food allergy with omalizumab compared to omalizumab-facilitated multi-allergen OIT. Journal of Allergy and Clinical Immunology DOI: 10.1016/j.jaci.2024.12.1022 (2025)