Tuesday , January 19 2021

Experimental treatment helps 2 of 3 patients with peanut allergy, research

“I wanted to sit with my good, good friends, but I couldn't,” said a 10-year-old man. “If you are a child and you have a food allergy, it’s getting harder and harder. You miss a lot of things that other children may have. I always want to try peanuts. ”

Mama Monica Glover said the family discovered Ellis's allergy to peanuts when she was about 3 years old. Recipe: The reaction of the skin around her mouth after she was given food with a small amount of peanuts in it. “We are lucky that I discovered it like this. It was a mild reaction, ”said Glover, and the doctor confirmed the allergy through the tests.

The discovery was "disturbing," Glover said. The accidental exposure to peanuts occurred, which led to "severe cramps in the stomach and vomiting," she said. "Essentially, we must all suffer from fear when Ellis is unintentionally exposed to peanuts and has a reaction that is potentially life-threatening."

Glover seized the opportunity to participate in a study on the safety and efficacy of experimental treatment that could protect her daughter from accidental exposure to peanuts. Despite the risk, it was a “gift,” she said, adding that her family hoped that their efforts could help “a lot of other children.”

The risk paid off: two-thirds of the children in the study were able to eat the equivalent of two peanuts without any symptoms after going through a month-long experimental treatment regimen, the researchers found.

Ellis is one of the most treated children. “It was a huge success,” her mother said.

The study, published on Sunday in the New England Journal of Medicine and presented at the American College of Allergy, Asthma and Immunology College Annual Meeting, confirms that treatment may protect some children from accidental exposure or ingestion of very small amounts of peanuts or peanuts.

Not medicine

Dr. Brian Vickery, lead author of the study, director of the Children's Hygiene Allergy Program in Atlanta, and associate professor of pediatrics at the Emory University School of Medicine, warned that "this is not a medicine."

“It does not cause allergies to go away,” said Vickery. “The goal is not to make them stop being peanuts, and let them have everything they want.”

However, this is no small achievement, he said. In the United States, there are no approved treatment options for food and drugs in the United States for food allergies of any kind or peanut allergy in particular, which, along with tree nuts allergy, affects approximately 3 million Americans and more.
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Aymune Therapeutics Inc., a California-based biopharmaceutical company that made an experimental product, will submit an application for marketing approval to the FDA in December, and the FDA has prescribed treatment worthy of an accelerated approval process.

“I tell patients when I see that I hope that patients will have access to the end of next summer, something like that,” said Vickery. He added that, although research has proven the effectiveness of treatment and safety only in children, adults are likely to benefit in the same way.

How the work worked

To test experimental therapy, 66 research centers in 10 countries recruited 554 participants who were between 4 and 55 years old and who were allergic to peanuts. Most – 496 participants – were between 4 and 17 years old.

The treatment that comes in filled capsules is oral immunotherapy, and the concept “treats allergies, gradually exposing people to what they are allergic to,” said Vickery. Essentially, the processing is a peanut powder.
Ellis participated in a study at the Children's Clinical Research Department of the Arkansas Children's Hospital in Little Rock, led by Dr. Stacie M. Jones, a professor of pediatrics and the head of the department of allergy and immunology at the University of Arkansas Medical Sciences and Arkansas Children's Hospital.
Ellis and Monica Glover in the pediatric clinical research group at Arkansas Children's Hospital in Little Rock.

“We were very well informed about the whole process,” said Glover. “You start with a super low dose and make your way up. You take him in a supervised hospital. Then you take it at home every day. ”

Two thirds of the study participants received treatment in the form of an increase in the number of times every two weeks until maintenance reached, when they received the equivalent of one peanut daily. The remaining participants were given a placebo. At the end of the study a year later, all participants were faced with the problem of “getting out of food”: they ate the equivalent of two peanuts under the supervision of a doctor.

Two thirds of the treatment participants were able to tolerate this exit dose without a serious reaction. Half tolerated even twice as much: a dose of four peanuts.

Patches for skin can help children. peanut allergy, the study says

Overall, participants experienced fewer side effects during the study than the researchers expected. “Intuitively, this process will cause some allergic symptoms in many patients,” said Vickery. The third completed a study with nothing more than mild side effects, such as abdominal pain.

Ellis had stomach pains and vomiting several times during the study, usually on days when her dose was increased to increase her tolerance. “The presence of stomach cramps is not very good,” she said. However, she usually broke free, and the cramps went quickly.

Erica Gibson, a registered nurse at the Children's Clinical Research Unit at Arkansas Children's Hospital in Little Rock, and Ellis Glover.

One day she felt her throat clench and "it was harder for me to breathe," she said. She went into anaphylaxis, a severe allergic reaction. The hospital staff responded immediately and gave her an adrenaline shot. “I felt safe with all the doctors and nurses around me, they can help you get through this,” she said.

Due to serious side effects, a little more than 11% of children fell out of the study. Among children who received treatment, 10% needed rescue epinephrine while out of control, compared with 53% in the placebo group.

“These treatments can really transform people's lives,” said Vickery, “and I saw that this was happening at first hand: a sense of relief [families] when a child becomes desensitized. ”

Attempting to be a “bite safe”

Dr. Scott Sicher, a professor of pediatrics and director of the Jaffe Food Allergy Institute at Icahn School of Medicine on Mount Sinai in New York, said the study is "the largest of three studies in pharmaceutical peanuts."

“This is what many families call an attempt to" bite in safety. " it does not mean that you treat allergies, it does not mean that you can eat peanut butter sandwiches, ”said Sisher, who did not participate in the study. "This is really just the best threshold, so if you accidentally ate something with a little peanut, you might not have a reaction or the reaction would not be so bad."

Although immunotherapy treatment is just a matter of gradually increasing your tolerance for peanuts, you can have a serious reaction at home. “This is not something you can try at home,” said Sicher.

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He said that Aimmune made peanuts into a “pharmaceutical grade” product. “Most people think of it as a medicinal food.” Doctors and patients know exactly how much you get, he said, “and this is important, because if you react to, say, 50th peanuts, you don’t want to be wrong when suddenly getting a tenth of a peanut. ”

Assuming that the treatment received FDA approval, Sisher said, the conversation between doctors and patients would be: “It’s better to just avoid food and ask many questions in restaurants and be very careful or do something like that, eat food and ask questions in a restaurant, but at least you know you have a little safety valve?

There are more than a few caveats when it comes to treatment regimens. First, it is a “commitment,” he said. You can not take a dose before exercise, and you can not miss a dose, otherwise you may have a serious reaction when you get it again.

Glover remarked, “This is somewhat destructive. You have to do it every day. As a rule, we take it after lunch. ” After receiving the medication, she added that parents should carefully monitor their children, not allowing them to become too active or too hot.

Sicher said: “The family that does this really, really, really should be a follower of the rule. It is not simple". He will still be worthy of it, he said.

If this becomes the first approved treatment, if it is covered by insurance, and if all the details about who it works best for were developed and the risks and benefits were clear, "it would be so surprising because we really no, there was something like that before, ”he said.

“It's not all that we hope for, but still fantastic to raise someone’s threshold from a tiny tiny amount of peanuts to a couple of peanuts or more,” said Sisher, who believes other allergies will develop in time: “ I can tell my patients that this may be right for them, but if not, we are looking at things that may be simpler and better in the future. ”

Glover admits that “this is not an ideal solution. I would say that it was some work to do this research, only in terms of time. ” However, if it took twice as long, she would do it: “This is calm.”

Although she doesn't like the taste of the medicine, Ellis also thinks it's worth it. “This is definitely better,” she told another child with an allergic allerty: “You know that you can be close to your friends when they have peanut butter on them.”

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