Xolair Significantly Reduces Food Allergy Reactions, Says Study

In a clinical trial, Johns Hopkins University School of Medicine researchers found that people with multiple food allergies taking Xolair (Omalizumab) could tolerate exposure to peanuts, milk, and several other allergenic foods.

The study, published February 25 in The New England Journal of Medicine, included 180 participants ages 1 to 55 with a history of allergic reactions to peanuts and at least two other foods. The participants received 16 to 20 weeks of placebo injections or omalizumab — an injectable monoclonal anti-IgE antibody used to treat asthma.

After 16 weeks of treatment, the scientists found that 67% of the participants treated with omalizumab could tolerate peanut protein at amounts equal to 2.5 peanuts, compared to 6.8% of participants given placebo injections.

Moreover, those given omalizumab could tolerate other common food allergens, including milk, egg, cashew, walnut, wheat, and hazelnut, in amounts sufficient to prevent most from reacting after accidental exposure.

The study authors say many participants treated with omalizumab could also tolerate peanut protein levels equal to roughly 15 peanuts, and about 50% could consume around 25 peanuts without experiencing a reaction.

What's more, roughly 69% of the participants could tolerate 1,044 mg of two allergenic foods, and 47% could tolerate three common food allergens.

Still, the drug's effectiveness varied. For example, 14% of the participants treated with omalizumab could not tolerate even the smallest amounts of peanut protein. Because of this, the scientists say people taking the medication will still need to avoid allergenic foods and always carry injectable epinephrine.

Robert Wood, M.D., Director of the Eudowood Division of Pediatric Allergy, Immunology, and Rheumatology, and Johns Hopkins Children's Center Professor of Pediatrics tells Healthnews that omalizumab is safe, and the only side effect noted in this study was injection site reactions such as localized redness or swelling at the injection site.

"Participants received injections every 2 weeks or every 4 weeks," Wood explains. "Dosages varied widely, mostly because the study included children from one year of age to adults."

Wood says people taking the medication would have to remain on it indefinitely, as there is no expectation the drug would provide protection after it's discontinued.

However, the cost of Xolair is around $3,663 per month on average, which may limit accessibility for many people.

In addition, Wood says an oral food challenge test under the supervision of a qualified healthcare provider is the only way to determine whether the drug is working.

"We are comfortable saying that most patients will be protected for small, accidental exposures but cannot determine the actual level of exposure without a food challenge," Wood says.

On February 16, the FDA approved omalizumab to treat multiple food allergies based on the preliminary results of this trial. Previously, the drug was only approved to treat persistent asthma in children ages 12 and older.

The agency says almost 6% of Americans have food allergies, which can cause potentially life-threatening reactions such as anaphylaxis.

Since treatment options for preventing food-related allergies are limited, the only way a person can prevent a reaction is to avoid consuming the offending food. However, this can be challenging, as some foods can become cross-contaminated during preparation, or a person might accidentally consume a food item that contains the allergen. This poses ongoing risks for people with food allergies.

But the FDA says Xolair could help lower those risks.

In an FDA press release, Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, explains, "While [Xolair] will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."


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