NEW YORK — Xolair, a 20-year-old asthma drug marketed by Roche and Novartis, significantly reduced allergic reactions in people with multiple severe food allergies in a late-stage study, researchers reported Sunday at a medical meeting.
Based on results presented at the American Academy of Allergy, Asthma, and Immunology meeting in Washington, the US Food and Drug Administration (FDA) earlier this month approved a drug for adults and children 1 year of age or older to reduce allergic reactions that can occur when accidental exposure.
Xolair, a monoclonal antibody chemically known as omalizumab, was first approved by the FDA in 2003 for the treatment of asthma.
People using the drug will still have to avoid the foods they are allergic to, but they may worry less about unknowingly eating small pieces of those foods, said study leader Dr Robert Wood of the Johns Hopkins Children’s Center in Baltimore.
“There are many patients and families for whom this will make a big difference in their lives,” Wood said.
The USDA estimates that food allergies affect about 2 percent of US adults and 4 to 8 percent of children. The most serious allergic reactions result in 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths each year.
The study involved 177 children aged 1 to 18 and three adults, all with severe food allergies.
At baseline, participants reacted to less than 100 milligrams of peanut protein, the equivalent of about one-third of a peanut, and less than 300 mg to at least two other allergens, including milk, eggs, cashews, walnuts, hazelnuts and wheat.
After treatment, 67 percent of participants who received omalizumab could eat the equivalent of about four peanuts without experiencing moderate to severe allergic reactions, compared to only 7 percent of patients who received placebo.
About 44 percent of those treated with the drug could eat the equivalent of about 25 peanuts, the researchers said.
The patterns were similar when patients were challenged with other foods.
In the Xolair group, 41% of cashew allergy patients could consume 1,000 mg without a moderate or severe reaction, compared to 3% in the placebo group. It was 66 pcs compared to 10 pcs for milk. The researchers found that among patients with egg allergies, 68 percent could tolerate the exposure after treatment compared to none in the placebo group.
Participants received 16 to 20 weeks of treatment with Xolair or a placebo every two or four weeks, based on their weight and the amount of allergy-related antibodies in their blood.
After further treatment for another 24 weeks in 38 children, “the majority of participants (showed) stable or increased thresholds,” the researchers said.
The study was also published Sunday in The New England Journal of Medicine.
