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SAN DIEGO, CA – A groundbreaking clinical trial has revealed that omalizumab (Xolair) demonstrates superior efficacy compared to oral immunotherapy (OIT) in treating individuals with severe multi-food allergies. The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), found that omalizumab resulted in a higher percentage of participants tolerating significant amounts of common food allergens.
The research, presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress, and published in The Journal of Allergy and Clinical Immunology, focused on individuals with extreme sensitivity to multiple food allergens.
The trial compared omalizumab, a medication that blocks the allergy-causing antibody immunoglobulin E, with OIT, a common treatment involving gradual exposure to increasing doses of allergens.
Results indicated that 36% of participants receiving an extended course of omalizumab could tolerate at least 2 grams of peanut protein, and two other allergens, by the end of the treatment period, compared to only 19% of those receiving multi-food OIT.
“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, M.D., M.P.H., director of NIAID. “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.”
The researchers attributed the difference primarily to the high rate of allergic reactions and intolerable side effects among OIT participants, leading 25% to discontinue treatment. However, when those who discontinued were excluded, both groups showed similar tolerance levels.
The study involved 177 children and adolescents, and three adults, all with severe allergies to multiple foods. Participants were divided into two groups, one receiving omalizumab and OIT, and the other receiving omalizumab and a placebo.
During the study, 29 participants in the OIT group discontinued therapy due to allergic reactions, while no participants in the omalizumab-only group experienced similar side effects.
“These results showed that omalizumab was more effective than OIT at treating multi-food allergy in people who originally had a very low tolerance to common food allergens,” the researchers noted.
The trial, known as OUtMATCH, provides valuable insights into alternative treatment options for individuals with severe multi-food allergies.
Further information about the OUtMATCH trial is available at ClinicalTrials.gov under study identifier NCT03881696.
Disclaimer: This news article is based on information from a clinical trial and should not be considered medical advice. Individuals with food allergies should consult with a qualified healthcare professional for personalized diagnosis and treatment. The information presented here is for informational purposes only and does not substitute professional medical guidance. Treatment options and their effectiveness can vary, and it is crucial to discuss any potential therapies with a doctor.
