A large study provides the strongest evidence that children and teenagers can be desensitized to peanut allergies through controlled, escalating…
A large study provides the strongest evidence that children and teenagers can be desensitized to peanut allergies through controlled, escalating exposure to a substance that could otherwise trigger a life-threatening reaction – a advance that specialists said were likely to herald the development of new food allergy drugs.
After a year of treatment with an experimental drug made by Aimmune Therapeutics, 67 percent of children and teenagers with peanut allergies were able to safely ingest the equivalent of at least two peanuts, compared with just 4 percent of those on placebo, according to the study published in the New England Journal of Medicine. Men den forbedringen kom til en pris ̵
1; næsten alle de undersøgelsesdeltagere, som modtog stoffet, et farmaceutisk-kvalitetspræparat af peanutmel, forårsagede uønskede hændelser af en eller anden type, og en i 10 blev trukket fra forsøget på grund af gastrointestinal, hud eller respiratorisk problems or systemic allergic reactions.
For years, smaller studies have suggested that exposure to escalating amounts of peanut allergens could desensitize people to the potentially life-threatening effects of exposure, which may include anaphylactic shock, but several outside experts said that the Large, systematic study of 550 people could lead to the first treatment approved by the Food and Drug Administration. De meeste deelnemers waren tussen de 4 en 17 jaar, de groep waarin onderzoekers het medicijn gevonden hebben om doeltreffend te zijn.
“Ik denk dat we op zoek zijn naar nu, waar er geen goedgekeurde behandeling voor voedselallergie is, twee a landscape where probably, in a few years, we will have a couple of options to offer our patients, “said Corinne Keet, a pediatric allergist at Johns Hopkins School of Medicine not involved in the study, and who said that that would amount to a sea change given the dearth of options today. “In the short term, the products that may come to market are not cures, but I think there are a number of different approaches being explored – and overall, the goal is more of a curative treatment.”
Aimmune, which funded the study, planer om at sende en ansøgning om stoffet til føderale regulatorer neste måned og forventer at det kan starte sent i 2019. Det er uklart hvor mye det ville koste, hvor lenge pasientene skulle få det, og om det ville blive dækket by insurance.
“For now, the advice will be for ongoing treatment,” said Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital and one of the study authors who have received trial funding and fees from Aimmune. “Videre studier vil være nødvendig for å adressere om etter noen år, noen mennesker kan endre regelmessig dosering. Det store flertallet af undersøgelsesdeltagere tolererede behandlingen, og jeg forventer at den samme vil være sann av sin bruk i den virkelige verden når og if it’s approved. “
The treatment is not a cure, and the regime may not appeal to anyone with food allergies. Patients came to a clinic every two weeks to have their dose gradually increased under supervision over a period of six months. They also took the drug at home daily.
“I think it’s important to remember what the goal of this treatment is – the goal is not to allow people to freely eat peanuts,” said Daniel Adelman, the chief medical officer of Aimmune . “Kids go out the door every morning, and their parents worry, this is the day they will be exposed to peanuts and potentially have a life-threatening reaction; the goal of this treatment is to help protect people from those potentially life-threatening reactions. “
Aimmune will expand the approach to other food allergies, testing whether a similar drug could work to desensitize children to egg allergies next year.
Experts warned that this kind of regimen should not be started at home. 19659002] There are an estimated 6 million children with food allergies in the United States. In an accompanying editorial, Michael Perkin, from the Population Health Research Institute at St. George’s University of London pointed out that the potential market for a therapy is billions of dollars. The Aimmune drug was a defatted peanut flour made through the rigorous manufacturing processes required of pharmaceutical products, which Adelman emphasized meant it was free of variability that could carry the danger of delivering the wrong dose.
Keet said one concern is whether parents and Children would understand the limits of the drug.
“We would still be asking patients to review labels, and do not ingest anything with peanut in them,” Keet said. “We do not know what people would end up doing Salmonella contamination in Turkey is widespread and unidentified
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