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The data follow the FDA approval of omalizumab for the reduction of allergic reactions, including anaphylaxis, that can occur after exposure to 1 or more foods.
The New England Journal of Medicine published data from stage 1 of the pivotal phase 3 OUtMATCH (NCT03881696) study evaluating the efficacy and safety of omalizumab (Xolair; Genentech, Roche) for peanut and 2 other common food allergies, following a late-breaking symposium at the American Academy of Allergy, Asthma, and Immunology Annual Meeting, according to a press release from the company.1,2
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Trial Name: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
ClinicalTrials.gov ID: NCT03881696
Sponsor: National Institute of Allergy and Infectious Diseases
Completion Date (Estimated): August 2026
The study data follows the FDA approval for the reduction of allergic reactions, including anaphylaxis, that can occur after exposure to 1 or more foods for those aged 1 year and older with immunoglobulin E (IgE)-mediated food allergies, according to an article published by Pharmacy Times. This approval marks the first and only medicine approved by the FDA that reduces allergic reactions for those with 1 or more food allergies.3
“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,” Robert Wood, MD, director of the Eudowood Division of Allergy, Immunology, and Rheumatology at the Johns Hopkins Children’s Center, said in the press release.1
The OUtMATCH study showed that omalizumab increased the amount of peanuts, milk, egg, wheat, and tree nuts including cashews, hazelnuts, and walnuts, that it took to cause a moderate to severe allergic reaction for those with multi-food allergies, according to the press release. Investigators included 180 individuals aged 1 to 55 years in Stage 1 of the clinical trial who were unable to tolerate up to 100 mg of peanut protein (approximately one-third of a peanut) and up to 300 mg of at least 2 other food proteins, which included milk, egg, cashew, hazelnut, and wheat.1
The primary endpoint included a single dose of 600 mg of peanut protein, with secondary endpoints including at least 1000 mg of milk, egg, wheat, cashew, hazelnut, or walnut protein, without experiencing a moderate to severe allergic reaction, according to the press release. Patients completed 4 separate blinded food challenges, which included a placebo ingredient, to assess the ability to consume the proteins.1
Investigators found that a statistically significant higher proportion of individuals receiving omalizumab were able to consume at least 600 mg of peanut protein, at 67% for the drug and 7% for the placebo in 177 individuals, and at least 1000 mg of milk, egg, and cashew protein, without experiencing moderate to severe allergic reactions. The results showed 66% of patients taking omalizumab were able to consume milk, 67% were able to consume egg, and 41% were able to consume cashew, compared to 10%, 0%, and 3%, out of 62, 71, and 99 individuals, respectively.1
For walnuts, approximately 64% receiving omalizumab could consume the protein compared to 13% with the placebo out of 78 individuals. Individuals receiving omalizumab could consume hazelnut and wheat at 65% and 75% compared to 14% and 13% with the placebo out of 24 and 20 patients, respectively.1
“Living with food allergies has a profound impact on patients and their families, causing significant stress and requiring constant vigilance,” R. Sharon Chinthrajah, MD, associate professor of medicine at the Stanford School of Medicine’s Sean N. Parker Center for Allergy and Asthma Research, said in the press 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
Omalizumab is not approved for the emergency treatment of any allergic reaction, according to the press release.1
