Xolair was superior to oral immunotherapy in both effectiveness and fewer side effects for people with one or more food allergies.
RT’s Three Key Takeaways
- The Phase 3 OUtMATCH study showed Xolair was more effective and had fewer side effects than multi-allergen oral immunotherapy (OIT) for treating food allergies, with 36% of Xolair-treated patients tolerating at least 2,000 mg of peanut protein and two other allergens compared to 19% in the OIT group.
- Stage 3 preliminary results indicated that many patients successfully introduced allergenic foods into their diets after stopping Xolair, though success rates varied by food type and some patients returned to avoidance due to adverse events.
- Xolair became the first FDA-approved treatment to reduce allergic reactions from accidental food exposure, but it is not a replacement for emergency treatment and patients must continue avoiding known food allergens.
New data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provide further evidence supporting the role of Xolair (omalizumab) for the treatment of one or more food allergies. Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches. OIT involves ingesting the food allergen, initially with a very small amount and gradually increasing the amount. These findings were largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.
Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient’s diet after stopping Xolair. These findings were featured as late-breaking symposiums at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities,” said R. Sharon Chinthrajah, MD, OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research. “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.”
“These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are deeply grateful to the leading research institutions who partnered with us on this groundbreaking study, along with the inspiring dedication of the study’s participants and their families.”
In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein (about eight peanuts) and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group (odds ratio=2.6, P=0.031).
After Stage 1 of the OUtMATCH study, which served as the basis for the FDA approval of Xolair for the treatment of food allergies, 117 patients (median age: 7 years) moved on to Stage 2, where they all initially received 8 weeks of open-label Xolair. Patients were then randomised to receive either multi-allergen OIT or placebo OIT while continuing Xolair for another 8 weeks. After that, the OIT group switched to placebo injections for an additional 44 weeks while the other group continued Xolair with placebo OIT.
After the full treatment period, patients were re-challenged with their three study-specific foods (peanut and two other foods from milk, egg, wheat, cashew, hazelnut, and/or walnut). The primary endpoint was tolerance of 2,000 mg or more for all three foods, which was met. Superiority was also demonstrated for numerous secondary endpoints, including tolerating two or more foods (P=0.004). These findings were largely driven by the high rates of AEs in the OIT group. Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%) and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.
The first 60 patients (median age: 8.5 years) from Stage 1 of the OUtMATCH study entered a 24-week open-label extension followed by Stage 3, which included dietary consumption of allergenic foods, rescue oral immunotherapy or food avoidance, depending on the results of the final food challenge and patient preferences. Patients were no longer receiving Xolair.
Each of the 60 patients received a treatment plan for each of their three study allergens. Of the 180 treatment plans, 82% (n=148) of initial treatment plans included dietary consumption of allergenic foods. After 12 months of follow-up, many patients were able to introduce allergenic foods in dietary form, although success rates were higher for milk, egg and wheat (61-70%) than for peanuts and tree nuts (38-56%). Success was defined as tolerating a median daily consumption of at least 300 mg of allergenic protein. The study found that reduced consumption of allergenic foods appeared to be related to symptoms and other factors (such as taste and aversion), with no clear predictors of dietary consumption success. Many patients returned to avoidance due to AEs and other factors. AEs included anaphylaxis, epinephrine use and two cases of eosinophilic esophagitis possibly related to dietary consumption. Stage 3 is ongoing and study investigators are continuing to analyse data from additional patients who completed Stage 2 and then entered Stage 3.
On February 16, 2024, the FDA approved Xolair for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
