Antibody Treatment Shows Positive Results in Protecting Children Against Accidental Exposure to Food Allergens

A monoclonal antibody, omalizumab, was shown to increase the amount of peanut, tree nuts, egg, milk, and wheat that multi-food allergic children could consume without having a moderate or severe allergic reaction after a 16-week course.

Around 67% of participants who completed the antibody treatment “could consume a single dose of 600 milligrams (mg) or more of peanut protein, equivalent to 2.5 peanuts, without a moderate or severe allergic reaction, in contrast with less than 7% of participants who received placebo.” The treatment protected against egg, milk, wheat, cashew, walnut, and hazelnut “at a threshold dose of 1,000 mg protein or more” as well.

On Feb. 16, the Food and Drug Administration (FDA) “approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adults and children aged 1 year and older with food allergy.” However, the FDA emphasizes that the antibody is “not approved for the emergency treatment of allergic reactions.”

NIAID is funding a multi-stage trial called “Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults, or OUtMATCH” across 10 locations in the United States. The first stage of the trial, which was designed “to see if taking omalizumab increased the threshold for the amount of food that caused allergic reactions,” yielded positive results.

In the first stage of the trial, people who had allergic reactions from small amounts of food allergens were split into a group that received a 16 to 20 week omalizumab treatment and a group that received a placebo. Indeed, 79 of the 118 omalizumab-treated children and adolescents, or 66.9%, “could consume at least a single dose of 600 mg or more of peanut protein without a moderate or severe allergic reaction during the post-treatment challenge, in contrast with four out of 59 children or adolescents, or 6.8%, who received placebo.”

Of the participants who received omalizumab without a moderate or severe allergic reaction, 67% “consumed a cumulative dose of 1,044 mg of peanut protein, or about four peanuts,” and 44% “ate a cumulative dose of 6,044 mg of peanut protein, or about 25 peanuts.” In addition, “most participants who had received omalizumab in the first stage maintained or increased the amount of food protein they could consume without an allergic reaction during the extension.”

NIH’s website has the news release.