AAAAI 2025: Omalizumab Shows Favorable Outcomes Versus Oral Immunotherapy in Multi‐Food Allergy Treatment

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New data indicates that treatment with omalizumab produces better outcomes and fewer adverse effects than oral immunotherapy (OIT) in people with multi-food allergies. Results from the randomized OUtMATCH stage 2 clinical trial will be presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress, being held February 28 - March 3, 2025.¹

“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,” lead author Robert A. Wood, MD, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, said in a press release.²

In the study, 117 participants (55% men; median age, 7 years) received either double-blind multi-allergen OIT with placebo omalizumab or omalizumab with placebo OIT. All participants underwent an initial 16 weeks of open-label omalizumab. At week 9, OIT (or placebo OIT) was initiated and escalated to a maintenance goal of 1000 mg for each participant’s study-specific food allergen. At week 16, participants transitioned to blinded injection therapy (omalizumab or placebo) for an additional 44 weeks before a cumulative food protein challenge of 8044 mg. The primary endpoint was defined as tolerance of at least 2000 mg of protein from all 3 foods (cumulative 4044 mg), according to the study abstract.¹

Results from the intent-to-treat analysis included²:

• Efficacy: The primary endpoint was achieved in 36% of participants in the omalizumab group compared with 19% in the OIT group (OR 2.6; P = .031). Omalizumab also demonstrated superior outcomes in tolerance of 2 or more food allergens.
• Safety: No serious adverse events occurred in the omalizumab group, whereas 30.5% of participants receiving OIT experienced serious events. Additionally, no participants in the omalizumab group discontinued treatment because of adverse events (AEs) compared with 22.0% in the OIT group. Epinephrine use was required to treat the AEs in 6.9% of the omalizumab group versus 37.3% of the OIT group.
• Study Completion: Overall, 88% of participants receiving omalizumab completed stage 2, compared with 51% in the OIT group.

In a related analysis, researchers evaluated the reintroduction of allergenic foods following omalizumab treatment. Sixty participants (58% men; median age, 8.5 years) who had completed placebo-controlled stage 1 of OUtMATCH entered a 24-week open-label omalizumab extension, followed by stage 3, during which omalizumab was discontinued. Study-specific foods included peanuts, cashews, eggs, milk, walnuts, hazelnuts, and wheat. An initial treatment plan that involved dietary consumption was implemented in 82% of these participants.²

“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,” lead author Jennifer A. Dantzer, MD, assistant professor of pediatrics at Johns Hopkins University School of Medicine, said in a press release.²

Success in dietary consumption was defined as a median daily intake of more than 300 mg of food protein at quarterly intervals over 12 months. The analysis demonstrated that, except for wheat, the median consumed protein declined over time. Success rates were higher for milk, egg, and wheat (61%–70%) compared with peanut and tree nuts (38%–56%). AEs reported during the reintroduction phase included episodes of anaphylaxis, epinephrine administration, and two cases of eosinophilic esophagitis; a number of participants ultimately reverted to strict avoidance.²

The findings from stage 2 suggest that omalizumab may offer a more favorable benefit–risk profile compared with multi-allergen OIT in the treatment of multi-food allergy, with the observed differences driven primarily by the lower incidence of adverse events and treatment discontinuation, according to the abstract.¹

References:

1. Wood R, Jones S, Dantzer J, et al. Treatment of multi-food allergy with omalizumab compared to omalizumab-facilitated multi-allergen OIT. J Allergy Clin Immunol. 2025;155(2). AB444. https://www.jacionline.org/pb-assets/Health%20Advance/journals/ymai/AAAAI_2025_LateBreaking_Abstracts-1738868845707.pdf

2. Omalizumab Is superior to oral immunotherapy in multi-food allergy treatment. News release. AAAAI. February 10, 2025. Accessed February 12, 2025. https://www.aaaai.org/about/news/news/2025/omalizumab