In treating multi-food allergies, especially in those with severe allergic reactions to even tiny doses of common food allergens, a recent clinical trial on omalizumab—marketed as Xolair—has found that it is more successful than oral immunotherapy (OIT). Underfunded by the National Institute of Allergy and Infectious Diseases (NIAID), the study indicated that omalizumab was better accepted by participants, which resulted in less therapy stopping than OIT.
Considered a commonly utilized method for treating food allergies in the United States, OIT entails progressively ingesting rising amounts of an allergen to desensitize the immune system. But this approach sometimes has major adverse effects, which makes it challenging for some people to keep on the therapy. By the end of the OUtMATCH trial—a novel study—36% of omalizumab recipients could tolerate at least 2 grams of peanut protein (equal to around eight peanuts) and two other allergens. By contrast, just 19% of individuals undergoing OIT reached the same degree of tolerance.
Appreciating the Study Results
Published in The Journal of Allergy and Clinical Immunology and presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress, the study draws attention to a major OIT issue: its great frequency of allergic reactions and unacceptable side effects. Many of the OIT recipients suffered from severe allergic responses, which caused one in four to stop their medication. But when researchers eliminated those who stopped out, both therapy groups showed the same degree of allergy sensitivity.
Director of NIAID, Dr. Jeanne Marrazzo underlined that for those with severe multi-food allergies, this study offers a novel and safer substitute. “People with very sensitive multi-food allergies used solely oral immunotherapy as their sole therapy choice. Given most people tolerate omalizumab quite well, this study indicates it is a good substitute. If adverse effects connected to treatment are not a concern, oral immunotherapy is still a good choice,” she said.
Omalizumab’s Mechanism
Bonding to immunoglobulin E (IgE), an antibody in charge of allergic reactions, omalizumab works. The medication greatly lowers sensitivity to allergens by stopping IgE from activating immune cells, therefore lessening of allergic reactions. Treating multi-food allergies, the OUtMATCH trial provides the first direct comparison between omalizumab and OIT.
Along with three people aged 18 to 55 years, the experiment included 177 children and adolescents ages 1 to 17 who had confirmed allergies to at least two other common allergens, including milk, eggs, wheat, cashews, walnuts, or hazelnuts, together with confirmed allergies to minute amounts of peanut and at least two other common allergens. Before being randomly split in two groups, the subjects received omalizumab injections for eight weeks.
Group A underwent eight weeks of omalizumab and multi-allergen OIT then 44 weeks of OIT with placebo injections.
For 44 weeks Group B kept getting omalizumab injections along with a placebo OIT.
This approach guaranteed that neither researchers nor participants knew who belonged in which group, therefore removing any result bias.
Why Omalizumab Exceeded OIT:
Of the 59 OIT-treated group members surveyed throughout the trial, 29—15 due to allergic reactions and 14 for other reasons—such as trouble eating the study foods—discontinuated medication. By contrast, seven members of the omalizumab-only group (Group B) departed the trial because of participation obligations rather than side effects.
Researchers checked whether participants could handle two other allergens and at least two grammes of peanut protein at the end of the treatment session. Comparatively to just 19% in the OIT-treated group, the data revealed that 36% of individuals in the omalizumab-only group effectively tolerated all three allergens. Analyzing just those who finished therapy, however, both groups displayed identical tolerance.
The results imply that although OIT can still be beneficial, its great side effect frequency reduces its success. Conversely, omalizumab seems to offer a better and safer substitute for those with extreme food allergies.
Future Consequences and Continuous Research
Under the direction of researchers from Johns Hopkins University and Stanford University, the OUtMATCH trial keeps looking at how omalizumab affects treatment for food allergies over long terms. NIAID funds the study; further assistance comes from pharmaceutical companies Genentech and Novartis, who produce and distribute omalizumab for the trial.
With food allergies growing more common, this finding gives millions of people experiencing potentially fatal allergic responses hope. Omalizumab offers a safer and more efficient alternative for patients all around since it has the ability to lower severe allergic reactions with less side effects, so transforming food allergy therapy.
