The effectiveness of the asthma drug Xolair in treating food allergies has been demonstrated by recent studies, which indicate that the drug significantly reduces the likelihood of severe reactions in patients.
Data presented concurrently at the annual meeting of the American Academy of Allergy, Asthma and Immunology in Washington, D.C., on Sunday and published in the New England Journal of Medicine, demonstrated that several weeks of injections of omalizumab (Xolair) reduced the severity of allergic reactions in certain adults and children as young as 1 who are allergic to peanuts and other foods like milk, eggs, and wheat.
Based on an intermediate analysis of the trial, the U.S. Food and Drug Administration enlarged the population for whom Xolair is approved to include those with food allergies only last week.
“I’m thrilled that people with multiple food allergies now have a viable new therapy option. According to Dr. Sharon Chinthrajah, the study’s senior author, “this new approach showed really great responses for many of the foods that trigger their allergies.” She is the acting director of Stanford Medicine’s Sean N. Parker Center for Allergy and Asthma Research.
“People with food allergies constantly run the risk of potentially fatal reactions from unintentional exposures,” said Dr. Robert Wood, the study’s principal author and the director of pediatric allergy and immunology at Baltimore’s Johns Hopkins University School of Medicine. Omalizumab may provide a layer of defense against minor, unintentional exposures, according to the study.
Wood and Chinthrajah were quoted in a news release from Stanford Medicine.
The researchers demonstrated that Xolair decreased an allergic reaction even in the event that a person consumed many foods to which they are allergic at the same time by incorporating a number of foods into the trial.
Food allergies have no known cure, and the only other FDA-approved treatment for them is an oral immunotherapy called Palforzia, which is used to treat peanut allergies in children aged 4 to 17.
For our patients who are food allergic, there is a genuine need for treatment that offers options and goes beyond caution, according to Chinthrajah.
The National Institutes of Health provided funding for the latest study.
180 persons with a history of peanut allergy and two or more additional food allergies were recruited by the researchers. For 16 to 20 weeks, each patient received an injection of Xolair or a placebo shot every two to four weeks, depending on their random assignment.
In examining the data, the researchers considered 177 individuals with ages ranging from 1 to 17.
“Of our 177, 68 were 5 or younger,” Wood said CNN, adding that Xolair had never been tested in youngsters under the age of six prior to this trial.
Wood continued, “It was very meaningful to have a large group of study participants in the very youngest age group.” “The safety of young children has not been studied, so that was an important, reassuring aspect of the study,” the author says. “We know a lot about this drug from all its years of use in asthma.”
Xolair was administered to 118 subjects in total, and a placebo shot was administered to 59.
Following 16 weeks of treatment, the study found that 79 out of the 118 patients, or roughly 67%, who received Xolair were able to tolerate 600 milligrams or more of peanut protein, or roughly 2.5 peanuts. In contrast, only roughly 7 percent of participants receiving placebo shots were able to achieve that.
Compared to the placebo group, those who took Xolair also had a higher likelihood of tolerating additional allergies such cashews, eggs, and milk.
However, Xolair is not inexpensive: The medication manufacturer Genentech estimates that the monthly list price for adults is $5,000 and for youngsters is approximately $2,900.
A Genentech representative, Lindsey Mathias, previously told CNN that “the actual cost paid by most patients is typically lower based on their insurance coverage and other financial assistance programs available.”
The researchers pointed out that more investigation is required to fully comprehend how Xolair might benefit those who have dietary sensitivities.
Many questions remain unsolved, such as how long patients must take this medication. Has the immune system been altered irreversibly by us? What characteristics indicate who will react most strongly? stated Chinthrajah. “We’re not sure yet.”