By Markita Lewis, RD, MS
On February 16, 2024, the Food and Drug Administration (FDA) approved Xolair (omalizumab) to be used for reducing allergic reactions to multiple foods after accidental exposure.
While not a cure for food allergy, Xolair is currently the first and only FDA-approved medication to reduce the severity of IgE-mediated allergic reactions in certain adults and children ages 1 year or older with one or more food allergies. Xolair is a monoclonal anti-IgE antibody injection, which is a treatment made of one type of antibody that helps reduce the activity of the specific protein called IgE involved in allergic reactions. Prior to its approval for reducing food allergy reactions, Xolair was used for certain patients with moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis.
“The National Peanut Board is proud to have supported research that improved the understanding of this treatment for peanut and other food allergies,” said NPB President and CEO Ryan Lepicier. “Since 2001, America’s peanut farmers have been committed to being part of the solution for peanut allergies. This FDA approval provides another option for food allergic individuals and their families to improve their quality of life with less fear of life-threatening reactions.”
The efficacy of Xolair for reducing allergic reactions in food-allergic adults and children was studied in the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (OUtMATCH) trial. Initial results of the study were published online in February in the New England Journal of Medicine, and it is the first of three planned stages of the study.
The OUtMATCH trial is a multicenter double-blind, randomized, and placebo-controlled study. Participants of the study included individuals ages 1 to 55 years with a history of a severe allergy to peanuts (acute reaction after a dose of 100 mg of peanut protein or less) and an acute reaction after consumption of 300 mg or less of two other protocol-specified foods (cashew, milk, egg, walnut, wheat and hazelnut). Inclusion in the study also considered body weight and serum IgE levels for dosing.
The primary outcome of the study was for participants to be able to tolerate 600 mg of peanut protein. The main secondary outcome was tolerance of consuming at least 1000 mg of cashew, milk and egg protein. Other secondary outcomes included observing tolerances of increasing doses of a single food, two foods, and three allergic foods during the food challenges.
Participants were randomized in a 2:1 ratio (n = 118 omalizumab, n = 59 placebo) to receive doses of omalizumab based on their weight and total IgE levels or a placebo every 2 to 3 weeks for a total of 16 to 20 weeks.
At the food challenge stage of the trial, 67% of the subjects who received Xolair were able to tolerate eating a 600 mg dose of peanut protein (approximately 4 peanuts) without moderate to severe side effects compared to placebo (7%), with decreasing effectiveness at higher doses (up to 4000 mg, or equivalence to 25 peanuts). Other protocol-tested foods had similar differences in the efficacy of omalizumab compared to placebo. The study also found some effectiveness in Xolair in participants trying two or three allergenic foods at once.
While this new approval is exciting news in the world of food allergy management, this treatment may not be for everyone. In the study, 14% of participants were still unable to tolerate more than 30 mg of peanut protein without a severe reaction after treatment. Additional limitations to this trial include having only three adult participants, a mostly non-Hispanic and white cohort, and exclusion of people with high baseline IgE levels.
Patients on Xolair are still recommended to avoid foods that they are allergic to, and under guidance of an allergist may choose other treatment options for management of their allergies. This medication also is not intended for immediate emergency treatment of allergic reactions, including anaphylaxis.
Overall, Xolair provides a new opportunity for individuals with food allergies to help prevent severe allergic reactions in the event of accidental exposure. As the OUtMATCH study enters its second stage, the allergy community hopes to learn more about omalizumab’s role in food allergy treatment.