Thu. Apr 25th, 2024

How it works and what it costs

By 37ci3 Feb26,2024

Kevin Wang and Annie Marqueling’s son, Liam, was 8 months old when he developed hives all over his body after eating a few pieces of hard-boiled egg. An allergy test revealed that Liam was also allergic to eggs peanuts and tree nuts, and the next year the whole family avoided foods that could cause a dangerous reaction.

“We had to pay special attention to every item we brought home because it could be a potentially life-threatening allergen for him,” Wang said. “There have been a few times when we’ve had to reach out and grab a cookie before taking a bite because we weren’t sure of the contents.”

Then, two years ago, Wang and Marqueling, who live in Palo Alto, Calif., learned that a decades-old drug called omalizumab was in clinical trials. The injectable drug was approved in 2003 under the name Xolair for chronic hives and allergic asthma, but now there’s evidence that it might be too. protects against severe allergic reactions to food.

They booked Liam into court.

Liam with his parents Annie and Kevin on his 5th birthday.
Liam with his parents Annie and Kevin on his 5th birthday.Courtesy Annie Marqueling

The results were published on Sunday New England Journal of Medicine. To participate in the clinical trial, patients had to be allergic to peanuts along with two other foods. After four months, many of the participants were able to tolerate small amounts of the food they were allergic to, meaning accidental exposure was no longer a life-threatening event.

Senior research author Dr. Dr. Sharon Chinthrajah, associate professor of medicine and pediatrics and acting director of the Sean Parker Center for Allergy and Asthma Research at Stanford University. Sharon Chinthrajah noted that Xolair is not curative and patients should still avoid eating. has an allergy. “But it’s a great layer of security,” he said.

“This therapy offers injections and offers an umbrella, safety protection to go out and live your life normally so that you don’t have to fear accidental exposures and everyday life,” Chinthrajah said.

Earlier this month Food and drug administration has expanded approval for Xolair to certain children and adults food allergybased on clinical trial results.

“The day the FDA approved the drug, we were writing prescriptions for our food allergy patients,” Chinthrajah said.

A much needed safety net

In the United States, 6% of people, including 6% of children, have food allergies. Centers for Disease Control and Prevention. According to research, about 40% of children with food allergies react to more than one food. Annals of Allergy, Asthma and Immunology.

So far only one drug, It is called Palforzia, has been available to protect against acute allergic reactions to food, and the drug only works for peanuts. In addition to peanuts, Xolair works for other common food allergies, including egg, milk, and wheat.

In a clinical trial, Chinthrajah and his team recruited 180 people at 10 US hospitals who were allergic to peanuts and at least two of the following foods: cashews, milk, eggs, walnuts, wheat or tree nuts. Participants ranged in age from 1 to 55 — about 40% were younger than 6 and most were younger than 18 — and 118 of them received a monthly or biweekly dose of Xolair. The rest received a placebo. Of the first 60 people who completed the initial phase of the trial – 59 were under 18 – it was extended for a further 24 weeks.

At the end of the initial four-month period, about 80% of people taking the drug were able to eat a small amount of one of the foods they were allergic to without having a normal reaction. About two-thirds were able to tolerate two to three peanuts, which is “far greater than the average accidental exposure,” Chinthrajah said.

About 70% can eat small amounts of two of the three allergic foods without having a reaction. About half could tolerate small amounts of all three.

Dr. “One of the biggest things for children and even adults living with food allergies is the fear of accidental exposure,” said Ruchi Gupta. “It gives comfort, at least for the small amounts they may be exposed to.”

When a person with a food allergy eats or occasionally comes into contact with that food, their immune system releases a flood of antibodies called IgE. These antibodies attach themselves to certain cells and cause a systemic reaction. Xolair is an antibody drug that acts like a sponge, binding to IgE antibodies and preventing them from sticking to these cells.

“The ability of medicine to do this is limited,” Gupta said. For this reason, the medication is designed to prevent minor accidental exposure reactions to allergic foods rather than allowing a person to indulge in them.

Marqueling and Wang don’t know whether Liam, now 5, received the actual drug or a placebo during the clinical trial.

And now she can tolerate small amounts of peanuts and tree nuts, so they believe it’s the real thing.

The court changed their experience as parents.

“We have an extra layer of comfort knowing he’s protected in those occasional exposures where mom and dad can’t always be around,” Wang said.

Access is extended

Xolair is not for everyone with food allergies. He it just works For people with Type I food allergy, meaning that the person always produces IgE antibodies when exposed to the food they are allergic to, it is not always effective – 20% of people in the study could not even tolerate it. Even when taking medicine, they trigger small amounts of food.

All experts stressed that people taking the drug still need to be careful.

“I think it will help reduce fear and anxiety, but definitely still avoid the allergen and Carry an EpiPenDr., an allergist and immunologist at Keck Medicine at the University of Southern California who was not involved in the trial. Asal Gharib Naderi said.

In rare cases, people can go into anaphylactic shock after taking Xolair, but Gharib Naderi said it usually happens when people start taking the drug, usually within the first three doses. These early doses are given in a doctor’s office, where the patient’s response can be monitored. Subsequent doses can be taken at home.

A spokesman for drugmaker Genentech said the estimated monthly list price of Xolair is about $2,900 for children and $5,000 for adults. Based on insurance and other financial assistance programs, actual out-of-pocket costs for patients are usually lower, the spokeswoman said.

Although Xolair could previously be prescribed off-label for food allergies, insurance companies rarely cover off-label uses. With the FDA’s expanded approval, doctors hope that more insurance companies will cover it for food allergies.

“I don’t want to increase the differences we see in food allergies with a drug like this,” Gupta said. “There are a few more treatments hot on the heels of Xolair, and we need to make sure they’re available.”

It’s not yet clear how long someone should stay on Xolair for food allergies, but that’s the subject of further research.

“This could potentially be a lifelong cure,” Chinthrajah said.

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By 37ci3

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