Phase III Study: Xolair Outperforms Oral Immunotherapy for Food Allergies

In a significant development for food allergy sufferers, a Phase III study has shown that Xolair (omalizumab) may be more effective and safer than oral immunotherapy (OIT) for treating multiple food allergies. The study, conducted by the National Institute of Allergy and Infectious Diseases (NIAID) and other collaborators, compared the efficacy and safety of omalizumab as monotherapy and as an adjunct therapy to multi-allergen oral immunotherapy in food-allergic children and adults.

The OUtMATCH trial enrolled 462 participants, aged 1 to 55 years, who were allergic to peanuts and at least two other trial-specified foods. The primary end point was the ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms.

The results were compelling: 67% of children and adolescents receiving omalizumab met the primary end-point criteria, compared to only 7% in the placebo group (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons).

Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group. This suggests that omalizumab may be a safer and better-tolerated treatment option for food allergies, particularly in children and adolescents.



The findings of this study have important implications for the treatment of food allergies. Omalizumab, as a monoclonal anti-IgE antibody, works by blocking the binding of IgE to receptors on cells, which in turn stops the release of the chemicals responsible for allergy symptoms. This mechanism of action makes it an attractive option for treating multiple food allergies, as it can reduce the risk of severe reactions to accidental exposures.

In contrast, oral immunotherapy requires eating gradually increasing doses of a food allergen, which can be time-consuming and inconvenient. In the OUtMATCH trial, a quarter of participants receiving OIT discontinued treatment due to adverse events, highlighting the burden of this treatment approach.

The cost-effectiveness of omalizumab treatment compared to oral immunotherapy will ultimately depend on individual patient preferences, insurance coverage, and the specific clinical context. However, the shorter treatment duration, lower incidence of side effects, and potential long-term benefits of omalizumab make it an attractive option for many patients.

In conclusion, the Phase III study of Xolair for the treatment of multiple food allergies has shown that omalizumab may be more effective and safer than oral immunotherapy. With its shorter treatment duration, lower incidence of side effects, and potential long-term benefits, omalizumab offers hope for improved quality of life for food allergy sufferers. As the study results are further analyzed and disseminated, it will be important for healthcare providers and patients to consider the potential benefits and risks of each treatment option.