When Kevin Wang and Annie Markering's son Liam was 8 months old, he developed hives all over his body after eating a few pieces of scrambled eggs. Allergy tests revealed that Liam was allergic to eggs, as well as peanuts and tree nuts, and for a year his entire family avoided foods that could cause dangerous reactions.
“We had to pay special attention to every item we brought into the house, as it could be a life-threatening allergen for him,” Wang said. “There were many times I had to reach out and take the cookie before I could eat it because I couldn't see what was inside.”
Then two years ago, Wang and Markering, who live in Palo Alto, Calif., learned about a clinical trial of a decades-old drug called omalizumab. The injectable drug, which was approved in 2003 under the name Xolair to treat chronic hives and allergic asthma, now has evidence that it can also protect against severe allergic reactions to food.
They registered Liam for trial.
The results were published Sunday in the New England Journal of Medicine. To participate in the clinical trial, the patient had to be allergic to peanuts and her two other foods. After four months, most participants were able to tolerate small amounts of the food they were allergic to. This means that accidental exposure is no longer a life-threatening event.
Dr. Sharon Chintraja, the study's senior author and associate professor of medicine and pediatrics at Stanford University and acting director of the Sean Parker Center for Allergy and Asthma Research, said Xolair is not a cure and patients should still avoid the foods they consume. pointed out that it was necessary. I have an allergy to “But it's a tremendous layer of safety,” she said.
“This therapy provides an injection and provides an umbrella, a safety protection, to go out and live a normal life without much fear of accidental exposure or daily life,” Chintoraja said.
Earlier this month, the Food and Drug Administration expanded approval of Xolair for certain children and adults with food allergies based on clinical trial results.
“The same day the FDA approved this drug, we were writing prescriptions for food allergy patients,” Chintoraja said.
A much-needed safety net
According to the Centers for Disease Control and Prevention, just over 6% of Americans (including 6% of children) have food allergies. According to a study published in the Annals of Allergy, Asthma & Immunology, approximately 40% of children with food allergies have reactions to more than one food.
Until now, there is only one drug available to prevent acute allergic reactions to food, called Palforzia, and this drug is only effective against peanuts. Xolair is effective against common food allergies such as peanuts, eggs, milk, and wheat.
For the clinical trial, Chintraja and her team recruited 180 people from 10 hospitals in the United States who were allergic to peanuts and at least two of the following foods: cashews, milk, eggs, walnuts, wheat, and hazelnuts. . Participants ranged in age from 1 to 55 years, with about 40% under 6 years and most under 18 years, and 118 of them received Xolair monthly or biweekly. The rest received a placebo. The first 60 people to complete the initial phase of the trial, 59 of whom were under 18, were extended for an additional 24 weeks.
By the end of the first 4-month period, about 80% of people given this drug can now eat a small amount of one of the foods they are allergic to without causing a normal reaction. Ta. About two-thirds were able to tolerate two to three peanuts, which is “much more than the average accidental exposure,” Chintoraja said.
Almost 70% were able to eat small amounts of two of the three allergic foods without any reaction. Almost half could tolerate small amounts of all three.
“One of the biggest challenges for children, and even adults, who live with food allergies is that they can't help but accidentally “It's a fear of physical exposure.” “This gives you peace of mind, at least for the small amount you may come into contact with.”
When someone with a food allergy eats, or in some cases comes into contact with, that food, their immune system releases large amounts of antibodies called IgE. These antibodies attach to specific cells and trigger a systemic response. Xolair is an antibody drug that acts as a sponge, binding to IgE antibodies and preventing them from attaching to these cells.
But “there are limits to what this drug can do,” Gupta said. Therefore, this drug is intended to prevent reactions to small accidental exposures to allergic foods, rather than to make you eat them.
Markering and Wang don't know whether Liam, now 5, received the actual drug or a placebo during the clinical trial.
But now that they can tolerate small amounts of peanuts and tree nuts, they believe it's real.
This trial changed their experience as parents.
“It gives us added peace of mind knowing that our son is protected in the event of an accidental exposure where mom and dad may not always be there,” Wang said. said.
Expanding access
Xolair is not intended for everyone with food allergies. This only works for people with type I food allergies. That is, the person produces her IgE antibodies whenever she is exposed to the food she is allergic to, but they are not always effective. His 20% of study participants had no effect. Be able to tolerate even small amounts of trigger foods even if you are taking medication.
All experts stressed that people taking the drug still need to be careful.
“I think it helps reduce fear and anxiety, but you should definitely still avoid allergens and carry an EpiPen,” said Dr. Asal Gharib-Naderi, an allergist and immunologist at Keck Medicine at the University of Southern California. Ta. trial.
In rare cases, people can go into anaphylactic shock after taking Xolair, but this usually happens when they start taking the drug, usually within the first three doses, Ghalib Naderi said. . These initial doses will be given in a doctor's office, where patient response will be monitored. Subsequent doses can be taken at home.
A spokesperson for the pharmaceutical company Genentech said the estimated monthly list price for Xolair is about $2,900 for children and $5,000 for adults. A patient's actual out-of-pocket cost is typically lower based on insurance and other financial assistance programs, a spokesperson said.
In the past, Xolair could be prescribed off-label for food allergies, but insurance companies rarely covered off-label use. With expanded FDA approval, doctors hope that insurance companies will be more likely to cover food allergies.
“We don't want drugs like this to further widen the disparities we already see in food allergies,” Gupta said. “There are quite a few other treatments that follow Xolair, and we need to make sure they are available.”
It is currently unknown how long you need to take Xolair for food allergies, but that is the subject of further research.
“This could potentially be a lifelong treatment,” Chintoraja said.
