Xolair Outperforms Oral Immunotherapy in Landmark Food Allergy Study

Roche's asthma drug Xolair (omalizumab) has demonstrated superior efficacy and safety compared to oral immunotherapy (OIT) in treating adults and children with multiple food allergies, according to new data from the Phase III OUtMATCH trial. The results, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, further solidify Xolair's position as the leading treatment option for food allergies.

Head-to-Head Trial Results

The OUtMATCH study, the first of its kind to directly compare Xolair with OIT, met its primary endpoint in Stage 2. Thirty-six percent of patients treated with Xolair monotherapy were able to tolerate at least 2,000 mg of peanut protein—equivalent to approximately eight peanuts—and two other food allergens without developing allergic reactions. In contrast, only 19% of participants in the OIT group achieved the same outcome, with the difference being statistically significant (p=0.031).

Dr. R. Sharon Chinthrajah, OUtMATCH co-lead study investigator and professor of medicine at Stanford, commented on the findings: "These results 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."

Safety Profile and Adverse Events

The study highlighted significant differences in the safety profiles of the two treatments. More than 30% of OIT participants experienced serious adverse events (AEs), with 22.2% discontinuing treatment due to toxicities. Notably, no Xolair-treated patients developed severe side effects or had to drop out of the study.

The disparity in safety was further emphasized by the rates of AEs requiring epinephrine treatment: 37% in the OIT group compared to only 7% in the Xolair arm. Roche attributed Xolair's advantage to the "high rates of adverse events leading to study discontinuation in the OIT-treated group."

Long-Term Efficacy and Food Introduction

Preliminary results from Stage 3 of the OUtMATCH study provided insights into the long-term effects of Xolair treatment. Many participants who discontinued Xolair were able to introduce allergenic foods into their diets, with varying degrees of success. Milk, egg, and wheat appeared to be more tolerable compared to peanuts and tree nuts.

However, the study also revealed that many patients eventually had to resume avoiding their allergic foods "due to AEs and other factors," including anaphylaxis and the need for epinephrine treatment. This phase of the study is ongoing, with researchers continuing to monitor the long-term outcomes of Xolair treatment.