Xolair Demonstrates Efficacy Reducing Multi-Food Allergic Reactions

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Following its approval by the FDA last week as the first drug indicated to treat multiple food allergies in patients as young as 1 year of age, data published in the New England Journal of Medicine (NEJM) demonstrated the ability of Novartis’ and Genentech’s Xolair (omalizumab) to significantly reduce severe reactions to several food allergies.¹ Findings from the pivotal Phase III OUtMATCH study show that the monoclonal antibody increased the amount of peanuts, milk, egg, wheat, and tree nuts patients could be exposed to before triggering a moderate to severe allergic reaction in those with multi-food allergies.²

On February 16, Xolair was approved to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy.³

“Over the past 35 years, I have seen how debilitating food allergies can be for patients and their loved ones, as they are consumed by the fear of accidental exposure,” OUtMATCH trial principal investigator Robert Wood, MD, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center, said in a press release. “While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy. The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure.”¹

OUtMATCH evaluated whether Xolair is as effective and safe as monotherapy in patients with multiple food allergies. Investigators sought to enroll individuals aged 1 to 55 years who experienced an allergic reaction to a food challenge of 100 mg or less of peanut protein and 300 mg of at least two other foods—cashew, milk, egg, walnut, wheat, or hazelnuts.

“Living with food allergy requires constant vigilance and has detrimental effects on nutrition, quality of life, personal finances, and health care utilization. Current management recommendations rely on food avoidance and emergency treatment if accidental exposure occurs,” the authors wrote. “Only one treatment has been approved by the Food and Drug Administration, an oral immunotherapy product for peanut allergy. Although oral immunotherapy has been shown to induce desensitization to specific food allergens, it is a burdensome therapy associated with a high incidence of adverse reactions. The development of therapeutic strategies that could address allergies to multiple foods simultaneously, reduce reactions to accidental exposures, and improve overall quality of life would be an important advance for affected persons.”²

Investigators randomly assigned 180 individuals in a 2:1 ratio, of whom 177 were aged 1 to 17 years, to receive Xolair or placebo administered subcutaneously every two to four weeks for 16 to 20 weeks, with the food challenges repeated after this point. The trial’s primary endpoint was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms, with key secondary endpoints that included consuming at least 1000 mg each of cashew, milk, and egg in single doses without dose-limiting symptoms.²

The trial data showed that a statistically significant (p<0.001) greater proportion of those administered Xolair could consume at least 600 mg of peanut protein and at least 1,000 mg of milk, egg, and cashew protein without triggering a moderate to severe allergic reaction compared to placebo. Further, a greater proportion of those in the Xolair cohort could consume at least 1,000 mg of walnut, hazelnut, and wheat protein without triggering a moderate to severe allergic reaction.

“These levels of protection are likely to exceed those that would be needed for the amounts of food that are typically encountered during accidental exposure, which highlights the possible use of omalizumab as monotherapy to reduce the daily risk of food allergic reactions while recognizing that this protection would require ongoing dosing as well as continued avoidance of allergenic foods,” the study authors wrote.²

The investigators noted that additional research will be needed to investigate the potential of disease modification with early and prolonged use of Xolair.

“Living with food allergies has a profound impact on patients and their families, causing significant stress and requiring constant vigilance,” OUtMATCH co-lead study investigator R. Sharon Chinthrajah, MD, associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research, said in the release. “The OUtMATCH study demonstrated that anti-IgE therapy increased most patients’ threshold for an allergic reaction. This presents an important new treatment option for patients and families in its potential to reduce the risk of allergic reactions from accidental exposures they may face in day-to-day life.”¹

References

1. New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies. Genentech. News release. February 25, 2024. Accessed February 26, 2024. https://www.gene.com/media/press-releases/15020/2024-02-25/new-england-journal-of-medicine-publishe

2. Wood R. et al. Omalizumab for the Treatment of Multiple Food Allergies. Journal Article. New England Journal of Medicine. 10.1056/NEJMoa2312382 [doi] 4100-https://www.nejm.org/doi/full/10.1056/NEJMoa2312382.

3. FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis. News release. February 16, 2024. Accessed February 26, 2024. https://www.novartis.com/us-en/news/media-releases/fda-approves-xolair-omalizumab-first-and-only-medicine-children-and-adults-one-or-more-food-allergies#:~:text=EAST%20HANOVER%2C%20N.J.%2C%20Feb.,patients%20aged%201%20year%20and