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Home / Health / The experimental treatment helps 2 out of 3 peanut allergy sufferers, according to the study

The experimental treatment helps 2 out of 3 peanut allergy sufferers, according to the study



"I wanted to sit with my good, good friends, but I could not," said the 10-year-old. "If you're a kid and have a food allergy, it's harder for you to miss a lot of stuff other kids can have, I always want to try peanut stuff."

Mom Monica Glover said the family had discovered Ellis' peanut allergy when she was about 3 years old. The Note: A skin reaction around the mouth after being given food with a small amount of peanuts. "We were lucky to find it this way, which was a mild reaction," Glover said, and a doctor confirmed the allergy by testing.

The discovery was "distressing," Glover said. There was an accidental exposure to peanuts, which led to "severe stomach cramping and vomiting". "Essentially, we have to live in fear all the time that Ellis is unintentionally exposed to peanuts and has a potentially life-threatening reaction."

Glover took the opportunity to participate in a study on the safety and efficacy of a product, an experimental treatment that could protect her daughter from accidental contact with peanuts. Despite the risk, it was "a gift," she added, adding that her family hopes her efforts "would help many other children."

The risk paid off: Two-thirds of the children in the study were able to do so The researchers found that after months of experimental treatment they eat the equivalent of two peanuts without symptoms.

Ellis is one of the most children for whom the treatment works. "That was a great success," her mother said.

The study results, 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, prove that the treatment can protect some children against accidental exposure or ingestion small amount of peanuts or peanut products.

No cure

Dr. Brian Vickery, lead author of the study, director of the Atlanta Food Allergy Program's Children's Health Program and an associate professor of pediatrics at Emory University's School of Medicine, warned, "It's not a cure."

"It does not make the allergy to go away," Vickery said. "The goal is not to get them to be no more peanut allergic and allow them to eat what they want."

Still, that's not a small accomplishment, he said. There are no US Food and Drug Administration-approved treatments for food allergies of any kind, or peanut allergies in particular, which together with tree allergy affects an estimated 3 million Americans or more.
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Aimmune Therapeutics Inc., a California-based biopharmaceutical company that manufactured the experimental product, will submit a regulatory filing request the FDA in December, and the FDA has designated the treatment as worthy of an accelerated approval process.

"I tell patients when I see them that I hope patients will have access by late next summer, something like that," Vickery said. He added that while the study proved the effectiveness and safety of treatment only in children, adults would probably benefit equally.

How the study worked

To test experimental therapy, 66 research centers In 10 countries 554 participants aged between 4 and 55 were recruited, all of whom had a peanut allergy. Most – 496 participants – were between the ages of 4 and 17 years.

The treatment, which is contained in powder-filled capsules, is an oral immunotherapy. The concept is to treat an allergy by gradually exposing people to people they are allergic to, "Vickery said, essentially treating it with a peanut powder.
Ellis accepted the study Pediatric Clinical Research Unit at Arkansas Children's Hospital in Little Rock, which was supervised by Dr. Stacie M. Jones, a professor of pediatrics and chief physician of allergy and immunology at the University of Arkansas Medical, Sciences and Arkansas Children's Hospital.
  Ellis and Monica Glover at the Pediatric Clinical Research Unit at Arkansas Children's Hospital in Little Rock.

"We were very well informed about the whole process," said Glover with an extremely low dose and work your way up. They take it in the observed hospital. Then take it every day at home. "

Two-thirds of study participants got an increasing treatment amount every two weeks until maintenance reached a daily equivalent of peanut, and the remaining participants received a placebo after one year, all participants were faced with an "exit food challenge": they ate the equivalent of two peanuts under medical supervision.

Two-thirds of the treatment participants tolerated this exit dose without severe reaction, and half tolerated twice the dose: a dose of four Peanuts.

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Overall, participants had There were fewer side effects during the study than the researchers had expected. "It's intuitive since This process would trigger allergic symptoms in many patients, "Vickery said. One third completed the study with no more than mild side effects such as abdominal pain.

Ellis suffered multiple episodes of stomach cramping and vomiting during the study, usually on days when her dose was increased to increase her tolerance. "Abdominal cramps did not feel very good," she said. Nevertheless, she usually vomited and the spasms passed quickly.

  Erica Gibson, Registered Nurse in the Pediatric Clinical Research Unit of the Arkansas Children's Hospital in Little Rock and Ellis Glover.

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

Just over 11% of children discontinued the study because of severe side effects. In children receiving the treatment, 10% had to be on epinephrine during withdrawal, compared with 53% in the placebo group.

"These treatments really do have the potential to change people's lives," Vickery said, "and I've seen it happen first-hand: The sense of relief [families] is achieved when a child becomes desensitized."

Attempt to bite

Dr. Scott Sicherer, a professor of pediatrics and director of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai, New York, said the study was "the largest of the Phase 3 studies in the pharmaceutical grade of peanuts".

"It's what many families call trying to" bite. "It's not that you cure the allergy, it's not like you can eat peanut butter sandwich," said Sicherer the study was not involved. "It really is just a better threshold, so if you've accidentally eaten something that contains a little peanut, you might not have a reaction or the reaction would not be that bad."

Immunotherapy treatment is simply a question of gradually increasing your tolerance to peanuts. You could have a serious reaction at home. "This is not something you should try at home," Sicherer said.

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He has made peanut a "pharmaceutical" product, he said. "Most people consider it a medicinal food." Doctors and patients know exactly how much you get, he said: "And that's important, because if you react to a 50th peanut, for example, you do not want to have a mistake where you suddenly get a 10th peanut."

Assuming the treatment is FDA-approved, Sicherer says, the conversation between doctors and patients will be: "It's better to simply avoid food and ask many questions in restaurants and be really careful, or you do that and you still do not eat the food and ask the questions in the restaurant, but at least you know you have a safety valve? "

There are more than a few limitations when it comes to the treatment regimen. For one thing, it's "an obligation," he said. You can not take a dose before training, and you can not skip the dose, or you may have a severe reaction if you pick it up again.

Glover remarked, "It's a bit disturbing, you have to do it every day, in general, we would take it after dinner." She added that parents need to monitor their children carefully to prevent them from becoming too become active or too hot.

Safer said: "The family that does this does not have to be really, really, a regular believer, not easy." It's still worth it for many, he said.

If this will be the first approved treatment, if it is insured and if details are clarified by whom it works best, then all have been calculated and the risks and benefits clear, "that would be so amazing because we did so had not really had anything before, "he said.

"It's not all we'd hope for, but it's still fantastic to raise someone's threshold from one to tiny amounts of peanuts for a few peanuts or more," said Sicherer, who believes that other allergy products are developed on time "I can tell my patients that this is right for them, but if they do not, then it's things that might be easier and better on the road."

Glover admits, "It's not I would say it was a bit of work to go through this study, just in terms of a time commitment. "But if it had taken twice as long, she would have done it:" It's a reassuring feeling. "[19659002] Although she does not like the taste of the remedy, Ellis also thinks it's worth it. "It's definitely better," she said to another child with peanut allergy: "You know you can be with your friends when they have peanut butter on them."


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