In a groundbreaking head-to-head trial comparing treatment approaches for food allergies, Xolair® (omalizumab) has demonstrated superior efficacy and safety compared to multi-allergen oral immunotherapy (OIT). The findings, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, mark a significant advancement in food allergy treatment options.
Superior Efficacy and Safety Profile
The Phase III OUtMATCH study revealed that 36% of patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without allergic reactions, compared to 19% in the OIT group (odds ratio=2.6, P=0.031). The study involved 117 patients with a median age of 7 years.
The safety data particularly favored Xolair, with striking differences in adverse events between the treatment groups. While the Xolair group reported no serious adverse events, the OIT group experienced:
- 30.5% serious adverse events
- 22% treatment discontinuation rate
- 37.3% requiring epinephrine treatment
"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," stated Dr. R. Sharon Chinthrajah, OUtMATCH co-lead study investigator from Stanford School of Medicine.
Post-Treatment Food Introduction Results
The study's Stage 3 preliminary results, involving 60 patients (median age 8.5 years), provided insights into maintaining treatment benefits after discontinuing Xolair. The findings showed varying success rates for different allergens:
- 61-70% success rate for milk, egg, and wheat
- 38-56% success rate for peanuts and tree nuts
Success was defined as tolerating a median daily consumption of at least 300 mg of allergenic protein. However, researchers noted that some patients returned to allergen avoidance due to adverse events and other factors, including taste aversion.
Clinical Impact and Market Position
Xolair's recent FDA approval in February 2024 positioned it as the first and only approved medicine for reducing allergic reactions in patients aged 1 year and older with IgE-mediated food allergies. This development addresses a significant medical need, considering that food allergies affect approximately 17 million Americans, with over 30,000 annual emergency room visits due to food-related anaphylaxis.
"These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community," said Dr. Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Treatment Protocol and Availability
Xolair is administered via subcutaneous injection, with options for healthcare provider administration or self-injection after initial treatment in a healthcare setting. The medication works by targeting and blocking immunoglobulin E (IgE), thereby reducing allergic inflammatory responses.
While the treatment shows promising results, healthcare providers emphasize that patients must continue avoiding their known food allergens, as Xolair is not intended for emergency treatment of allergic reactions or anaphylaxis.
