The FDA has approved omalizumab for reduction of food allergy reactions.
Two thirds of patients taking omalizumab monotherapy were able to eat at least six times their reaction threshold for peanut allergy, as well as significantly increasing their threshold for some other common food allergens, a US study has found.
On the strength of the OUtMATCH study, the FDA has now approved omalizumab (Xolair, Novartis) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in patients aged one year and older with IgE-mediated food allergy.
Around 180 participants aged one to 55 years old who had reaction thresholds of 100mg or less to peanut protein and 300mg or less to at least two other foods such as cashew, milk and eggs were enrolled in the OUtMATCH study.
Findings were presented at the recent American Academy of Allergy, Asthma and Immunology Annual meeting in February and published in NEJM.
Patients were randomised 2:1 to receive subcutaneous omalizumab, a monoclonal anti-IgE antibody currently approved to treat allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria, or placebo injection.
Omalizumab was given every two to four weeks for 16-20 weeks, based on the dosage and frequency indicated for individual weight and total IgE levels.
Of the 118 patients in the treatment group, 67% reached the primary endpoint of ingesting 600mg or more of peanut protein (approximately four peanuts) without dose-limiting symptoms occurring, compared to only 7% of the placebo group.
And 44% of the treatment group were able to consume even more, ingesting a cumulative 6044mg of peanut protein (approximately 25 peanuts) — more than the typical accidental exposure amount.
The key secondary endpoints were ability to consume 1000mg of cashew, milk and eggs in single doses without dose-limiting symptoms. There was a significant improvement to the reaction threshold for participants receiving omalizumab compared with the placebo group (cashew, 41% vs 3%; milk, 66% vs 10%; and egg, 68% vs 0%).
A large percentage of participants were able to consume multiple allergens without adverse effects, with 80% able to consume a cumulative dose of 1044mg of one allergen, 69% able to consume 1044mg of two allergens, and 47% able to consume 1044mg of three allergens.
“This finding could be important for persons who have multiple food allergies, because this amount of food protein is larger than a whole nut, a bite of a baked good, or a sip of milk,” the authors noted.
“Omalizumab could provide day-to-day protection irrespective of the specific food allergy.”
Presented today at #AAAAI24:
— NEJM (@NEJM) February 25, 2024
In this trial involving 180 persons with food allergies, omalizumab was effective in increasing the reaction threshold for peanut and other common food allergens. Full trial results: https://t.co/FKbAqMmw6p pic.twitter.com/ozNMX8ixxm
There are no immunotherapy options in Australia for food allergy. Current practice relies on food avoidance and emergency exposure response.
In the US, there is one oral immunotherapy approved for the treatment of peanut allergy, but researchers say it is a burdensome treatment associated with a high incidence of adverse effects, prompting the need for alternative therapies to be developed.
This placebo comparison is only the first stage of the trial. It will be followed by a 52-week study of comparing omalizumab with oral immunotherapy, and then a final stage of long-term ongoing allergen consumption in the home after discontinuing treatment.
Injection site reactions were more common in the treatment group than the placebo group, and there was only one incidence of a serious adverse event in which elevated liver enzyme levels occurred. After evaluation, it was determined that it was unlikely to have been caused by omalizumab.
The New England Journal of Medicine 2024, online February 25
