A new study finds that the asthma medication Xolair may substantially reduce severe allergic reactions in people who have multiple food allergies and are accidentally exposed to those foods.
Data published Sunday in the New England Journal of Medicine shows that repeated injections of the medication over the course of several weeks reduced the severity of allergic reactions in certain adults and children as young as 1 who are allergic to peanuts and other foods such as milk, egg and wheat.
The US Food and Drug Administration expanded its approval of omalizumab, which is marketed under the brand name Xolair, last week to include people with food allergies based on an interim analysis of the study.
By including several foods in the new study, the researchers were able to determine that Xolair could, in theory, reduce an allergic reaction if a person were to consume multiple foods that they’re allergic to at one time, experts say.
“This is an amazing step forward in our field,” said Dr. Sharon Chinthrajah, a senior author of the study and an associate professor at Stanford University. “There’s so much fear and anxiety that goes into everyday activities for food allergy patients or parents of a food allergy patient.”
Xolair gives people with food allergies some protection against accidental exposure that could result in anaphylaxis, a serious and sometimes life-threatening allergic reaction that requires immediate medical treatment, including an epinephrine injection, she said.
“I have patients who are in their teens with just a peanut allergy who have never been allowed to eat in the restaurant because there’s that much fear of the unknown,” said Dr. Robert Wood, lead author of the study and director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.
There is no cure for food allergies, and the only other FDA-approved treatment is Palforzia, an oral immunotherapy for peanut allergies in children between 4 and 17 years old. “But the reality is that most of our patients don’t just have peanut allergy,” Wood added. “Having something that’s really agnostic to the specific food is going to cover far more food allergy patients.”
Successful treatment in children
Xolair is developed and promoted by Genentech and Novartis in the US and was approved in 2003 to treat moderate to severe persistent allergic asthma.
For its approval for people with food allergy, the FDA required a phase 3 placebo-controlled trial including a “full dataset of peanut-allergic people,” Wood says, because peanut allergies are among the most common food allergy, especially in children. The foods used in the study were peanut, cashew, egg, milk, walnut, hazelnut and wheat, which are some of the most common allergens, Wood said.
For the study, which was funded by the National Institutes of Health, the researchers enrolled 180 people with a history of peanut allergy and at least two other food allergies. Each was randomly assigned to a group that got an omalizumab injection or a placebo every two to four weeks for 16 to 20 weeks.
All but three of the participants were 17 or younger, the researchers noted. The adults in the study were between 19 and 28, according to Wood. When analyzing the results, the researchers looked at the 177 participants who were between the ages of 1 and 17.
“Out of our 177, 68 were ages 5 or below,” Wood said, noting that before this trial, Xolair had never been studied below the age of 6. This is especially important, the researchers say, because the prevalence of food allergy peaks at 1 to 2 years old.
“To have a large group of study participants in the very youngest age group was very meaningful,” Wood said. “We know a lot about this drug from all its years of use in asthma, but the safety of young children has not been studied, so that was an important reassuring aspect of the study.”