Omalizumab Beats OIT in First Head-to-Head Multi-Food Allergy Trial: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On March 13, 2025, we reported on the first-ever head-to-head trial of omlizumab (Xolair; Genentech, Novartis) and multi-allergen oral immunotherapy (OIT) for the treatment of food allergies presented at the 2025 American Academy of Allergy, Asthma, and Immunology meeting.

The study

Researchers presented data from stage 2 and stage 3 of the NIH-sponsored phase 3 Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH) trial.

Stage 2 of the OUtMATCH study was the first head-to-head trial comparing omlizumab to OIT. A total of 117 patients (55% male; median age, 7 years) received omalizumab for 16 weeks. At 9 weeks, patients also began receiving multi-food OIT or placebo OIT, with doses increasing to 1000 mg of each allergen. Participants continued to receive omalizumab or began receiving a placebo at 16 weeks, which continued through 44 weeks, followed by a challenge with a cumulative dose of 8044 mg of their allergens.

Stage 3 of the OUtMATCH study provided preliminary data on introducing allergenic foods after discontinuing omalizumab. Among 60 participants, 82% (n=148) were initially advised to consume allergenic foods.

The findings

OUtMATCH stage 2 results showed that 36% of patients treated with omalizumab monotherapy could tolerate at least 2000 mg of peanut protein and the same amount of 2 additional food allergens without an allergic reaction, compared to 19% in the OIT group (OR 2.6, P =.031). Omazlizumab-treated participants also showed the ability to tolerate at least 2 allergenic foods (P =.004). Investigators also reported significantly higher rates of adverse events (AEs) in the OIT group, including serious AEs (30.5% vs 0% for omalizumab), AEs leading to treatment discontinuation (22% vs 0%), and AEs requiring epinephrine (37.3% vs 6.9%). The tolerability outcome suggests a safety profile for omalizumab that is superior to OIT for persons with multiple food allergies.

Stage 3 results showed that after 12 months of follow-up, many participants were able to introduce allergenic foods, with higher success rates for milk, egg, and wheat (61% to 70%) compared to peanuts and tree nuts (38% to 56%). Stage 3 is ongoing, with further analysis expected, including of Stage 2 completers who entered Stage 3.

Author's comments

"Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities. These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients.”

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