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Experimental treatment helps 2 out of 3 peanut allergists, study film

"I wanted to sit with my good, good friends, but I could not," said the 10-year-old. "If you are a…

“I wanted to sit with my good, good friends, but I could not,” said the 10-year-old. “If you are a child and you have a food allergy, it’s harder on you. You do not have many things other children can have. I always want to try groundnuts.”

Mother Monica Glover said that the family discovered Ellis’s peanut allergy at about 3. Tipoff: a skin reaction around her mouth when she fed a small amount of peanuts in it. “We were lucky to have discovered it that way. It was a mild reaction,” says Glover, and a doctor confirmed the allergy through tests.

The discovery was “disturbing,” says Glover. Temporary exposure to peanuts has occurred, resulting in “severe stomach cramps and vomiting,” she said. “Basically, we must live in fear all the time as Ellis is accidentally exposed to peanuts and has a reaction that is potentially life threatening.”

Glover took advantage of the opportunity to participate in a study on the safety and efficacy of an experimental treatment that can give her daughter protection against accidental exposure to peanuts. Despite the risk, it was “a gift,” she said, adding that her family hoped their efforts could help “many other children.”

The risk was paid: Two thirds of the children in the study could eat the equivalent of two peanuts without any symptoms after following the many years of experimental treatment regimen, researchers found.

Ellis is one of most children for whom treatment works. “It has been a great success,” said her mother.

The results of the study, published Sunday in the New England Journal of Medicine and presented at the American College of Allergy, the Annual Scientific Meeting of Asthma and Immunology, show that treatment can protect some children from accidental exposure to or ingestion of a very small amount of peanuts or peanut products.

No cure

Dr. Brian Vickery, the lead author of the study, Director of Child Care in the Atlanta Food Allergy Program and Professor of Pediatric Medicine at Emory University’s School of Medicine, warned that “it’s not a cure”.

“It does not make allergies go away,” said Vickery. “The purpose is not to make them no longer be peanut allergy and let them eat what they want.”

Still, it’s no small achievement, he said. There are no American food and drug administration-approved treatment options for food allergies of any type or peanut allergy in particular, which together with tree nutrition affects estimated 3 million Americans or more.

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Aimmune Therapeutics Inc., California-based biopharmaceutical company that made the experimental product, will submit an application for marketing authorization to the FDA in December , and the FDA has considered treatment to host a faster approval process.

“I tell patients when I see them I hope patients will get access later in the afternoon, something like that,” said Vickery. He added that although the study showed that the efficacy and safety of treatment were only in children, adults would probably benefit in the same way.

How the Study Worked

To test the experimental therapy, 66 research centers in 10 countries recruited 554 participants ranging from 4 to 55 and all of whom had peanut allergy. Most – 496 participants – were between 4 and 17 years old.

The treatment, which comes in powdered capsules, is oral immunotherapy and the concept “treats allergy by gradually exposing people to it. The same are they allergic to,” said Vickery. Essentially, the treatment is a peanut powder.

Ellis participated in the study at the Pediatric Clinical Research Unit at Arkansas Children’s Hospital in Little Rock, supervised by Dr. Stacie M. Jones, Professor of Pediatrician and Head of Allergy and Immunology at the University of Arkansas for Medical Science and Arkansas Children’s Hospital.

 Ellis and Monica Glover in the Clinical Research Unit for Children in 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 work you up. You take it to the hospital during observation. Then you go home every day. “

Two thirds of the study participants received treatment more and more every two weeks until they obtained maintenance when they received a corresponding peanut daily. The rest of the participants were given a placebo. At the end of the study after a year All participants met a “feed assessment”: They ate under a doctor’s supervision corresponding to two peanuts.

Two thirds of the treatment participants were able to tolerate this starting dose without a serious reaction. The half even tolerated twice as much: a four peanut dose.

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Overall, the participants experienced fewer side effects during the study than the researchers had expected. “It is intuitive that this process would trigger some allergic symptoms in many pations nter, “said Vickery. One-third completed the study with only mild side effects, such as stomach upsets.

Ellis experienced abdominal cramps and vomiting several times during the study, usually on days when her dose was increased to increase her tolerance. “Having stomach cramps did not feel so good,” she said. Nevertheless, she usually demanded, and the cramps went fast.

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

Once she felt her throat and “it was harder for me to breathe,” she said. She had gone to anaphylaxis, a serious allergic reaction. The hospital staff responded immediately and gave her a shot of epinephrine. “I felt safe with all doctors and nurses around me. They can help you get through it,” she said.

Little more than 11% of the children were released from the study due to severe side effects. Among children receiving treatment, 10% rescued pain relief in the starting challenge, compared to 53% in the placebo group.

“These treatments really have the potential to transform people’s lives,” said Vickery, “and I’ve seen it happen first hand: the sense of relief [families] gets when a child becomes desensitized.”

Trying to be ” bitt sure “

Dr. Scott Sicherer, a professor of pediatrics and head of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai, New York, said that the study is “the largest of phase three studies in pharmaceutical grade peanuts”.

“It’s what many families call trying to be a” bite safe “. It’s not like you’re curing the allergy, it’s not that you’ll be able to eat sandwiches, said Sicherer, who was not involved in the study. “It’s really just getting a better threshold so if you accidentally ate something that had a little peanut in it, you might not get a reaction or if the reaction would not be so bad.”

Although immunotherapy treatment is simply a matter of gradually increasing your tolerance to peanuts, you can get a hard reaction at home. “This is not something to try at home,” says Sicherer.

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Aimmune has made peanut into a “pharmaceutical grade” product, he said. “Most people like it as medicated food.” Doctors and patients know both e xakt how much you get, he said, “and it’s important that if you’re reactive to say a 50th peanut, you do not want a mistake where you suddenly get a 10th peanut. “

Assuming the treatment wins FDA approval, Sicherer says that the conversation between doctors and patients becomes” Is it better to just avoid the food and ask many questions at restaurants and be really careful, or do something like this and eat Still do not have the food and ask the questions in the restaurant, but at least you know that you have a little safety valve? “

There are more than a few approaches to the treatment regimen. For one, it’s” an engagement, “he said. You can not take a dose before training and you can not skip doses or you can get a difficult response when picking it up again.

Glover noted: “There is something disturbing. You have to do it every day. , we should take it after dinner. “After giving the drug, she allowed the parents to carefully supervise their children, prevent them from becoming too active or too hot.

Sicherer said,” The family that really does, really needs to be a rule follower. not easy. “It would still be worth it too many, he said.

If this does not end up being the first approved treatment, if it is covered by insurance and details about what it works best, everyone was elaborated and the risks and benefits were Clearly, “it would be so amazing, because we have not had anything like that before,” he said.

“That’s not all we hope for, but it’s still great to be able to raise someone’s threshold from a teeny small amount of peanuts to a few peanuts or more, “says Sicherer, who believes that other allergy products will develop in time:” I can tell my patients that this may be right for them, but if not “We look at things that can be easier and more better on the road. “

Glover acknowledges that “it’s not a perfect solution. I would say that there has been some work going through this study, only when it comes to engagement.” But if it had taken twice as much time, she would have Made it: “It’s peace of mind”.

Although she dislikes the medical taste, Ellis thinks it’s worth it. “It’s definitely better,” she would say to another child with peanut allergy: “You know you can be around your friends when they have peanut butter on them.”

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