Food allergic patients have better outcomes with omalizumab than oral immunotherapy
Milwaukee, WI – Food allergy treatment with omalizumab resulted in better outcomes with fewer adverse effects than oral immunotherapy according to new research being presented at the 2025 AAAAI / WAO Joint Congress in San Diego, CA, later this month.
“Both omalizumab and oral immunotherapy (OIT) are used to treat multi-food allergy, but the two treatments have previously never been directly compared. In this study we found that omalizumab was superior to OIT in the treatment of multi-food allergy, but that these differences were largely driven by the high rate of adverse events and study discontinuation in the OIT-treated participants,” said Robert A. Wood, MD, FAAAAI, lead author of the OUtMATCH study and Director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.
Researchers compared omalizumab and oral immunotherapy (OIT) to evaluate differences in their effectiveness for treating multi-food allergy. In OUtMATCH Stage 2, 117 participants were randomized to receive either double-blind multi-allergen OIT and placebo omalizumab or to receive omalizumab and placebo OIT. All participants initially received 16 weeks of open-label omalizumab, and at week 9 the OIT and placebo-OIT were initiated and escalated to the maintenance goal of 1000mg for each participant’s study-specific foods. At week 16, participants transitioned to double-blind injection therapy, either receiving omalizumab or a placebo, for 44 weeks before being re-challenged to a cumulative amount of 8044mg of protein for their study-specific foods. The protocol-defined primary endpoint was a tolerance of at least 4044mg for all three allergic foods.
Of the participants, 55% were male with a median age 7 years old. By the end of the study, 88% of participants in the omalizumab group completed Stage 2 while only 51% of participants in the OIT group completed the trial. In the intent-to-treat analysis of the primary endpoint, researchers found that omalizumab was superior to OIT with a success rate of 36% compared to only 19% with OIT. Omalizumab was also found to be superior to OIT for tolerance of two or more food allergens.
None of the omalizumab group experienced serious adverse events compared to 30.5% in the OIT group. Similarly, there were no adverse events leading to treatment discontinuation for the omalizumab group compared to 22.0% of the OIT group, and adverse events treated with epinephrine occurred in 6.9% of the omalizumab group compared to 37.3% in the OIT group. While omalizumab was found to be superior to multi-allergen OIT in the treatment of multi-food allergy, these differences were driven largely by the higher rates of adverse events in the OIT-treated participants, despite both groups having received omalizumab treatment at the start of the trial.
An additional study evaluating the introduction of allergenic foods, after receiving treatment with omalizumab, was also performed, finding that most patients were able to reintroduce allergenic foods.
“The results of Stage 1 of the OUtMATCH study led to the FDA approval of omalizumab for food allergy. Here we provide results about the first 60 participants who stopped omalizumab and then introduced allergenic foods after a food challenge. We found that most participants were able to introduce allergens in a retail food form, but reactions did occur, and many returned to strict avoidance,” said lead author Jennifer A. Dantzer, MD, FAAAAI, Assistant Professor of Pediatrics at Johns Hopkins University School of Medicine.
In this research, the first 60 participants completing the placebo-controlled Stage 1 of OUtMATCH entered a 24-week open-label omalizumab extension, followed by Stage 3 where they ceased the use of omalizumab. Stage 3 could include dietary consumption, rescue oral immunotherapy or food avoidance, depending on the results of the final food challenge and participant preferences.
Of the 60 participants, 58% were male with a median age of 8.5 years old. The tested foods included peanut, cashew, egg, milk, walnut, hazelnut and wheat, and 82% of initial treatment plans included dietary consumption. The research found that consumed food protein declined over 12 months, except for wheat, with greater variability for egg, milk and wheat relative to nuts. For participants who started dietary consumption, success was defined as a median daily consumption of more than 300mg food protein by quarterly intervals over 12 months, with overall greater success for milk, egg and wheat at a rate of 61% to 70% compared to peanut and tree nuts at a rate of 38% to 56%. The study found that reduced consumption appeared related to both symptoms and other factors such as taste and aversion, with no clear predictors of dietary consumption success. Adverse events included episodes of anaphylaxis and epinephrine use and two cases of EoE related to dietary consumption.
In food introduction following 24-48 weeks of omalizumab, most participants were able to introduce allergenic food in a dietary form, although adverse reactions did occur, and many participants returned to avoidance.
Visit aaaai.org to learn more about food allergies. Research presented at the 2025 AAAAI / WAO Joint Congress, February 28 – March 3 in San Diego, CA, is published in an online supplement to The Journal of Allergy and Clinical Immunology (JACI).
The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists and other professionals with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI is the go-to resource for patients living with allergies, asthma and immune deficiency disorders.
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Candace Archie, Communications & Public Relations Manager
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