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A large study provides the strongest evidence that children and adolescents can be sensitized to peanut allergies by increasing and controlled exposure to a substance that may otherwise trigger a life-threatening reaction – a breakthrough that experts say , could announce the development of a new food allergy drugs.
After one year of treatment with an experimental drug manufactured by Aimmune Therapeutics, 67% of peanut-allergic children and adolescents were able to safely ingest the equivalent of at least two peanuts, compared with just 4% of those under placebo, according to the study. published in the New England Journal of Medicine.
But this improvement came at a cost: almost all of the study participants receiving the drug, a pharmaceutical grade peanut meal, experienced some kind of side effects, and one in ten withdrew of the test because of gastrointestinal, skin or respiratory disorders. systemic problems or allergic reactions.
For years, small studies have suggested that exposure to increasing amounts of peanut allergen could desensitize people to potentially lethal effects of exposure, which may include anaphylactic shock , but several outside experts said the extensive systematic study conducted at 550 people could at the first treatment approved by the Food and Drug Administration. The majority of participants were aged 4 to 17, a group in which the researchers found the drug effective.
"I think we are considering going from an approved treatment-free treatment for food allergies to an environment where probably in a few years we will have a few options to offer our patients," said Corinne Keet. , a pediatric allergist at the Johns Hopkins School of Medicine who did not participate in the study and said it would be a "radical change" given the current scarcity of options. "In the short term, the products likely to be on the market are not curative treatments, but I think that different approaches are being explored – and overall, the goal is more of a treatment curative."
Aimmune, which funded the study, plans to submit a drug application to the federal regulators next month and plans to launch it in late 2019. It is unclear how much it would cost, how long patients should take it, and if would be covered by insurance.
"At the moment, the advice will focus on the current treatment," said Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital and one of the study's authors who received funding from 39, essay and fees from Aimmune. "Further studies will be needed to determine if, after a few years, some people may change the usual dosage." The vast majority of study participants have tolerated the treatment. </ P> <p> I expect that The same is true of its use in the "real world" when and where it is approved. "
The treatment is not a cure, and the diet may not appeal to all people with food allergies. Patients visited a clinic every two weeks to see their dose gradually increase under supervision over a six-month period. They also took the medicine home every day.
"I think it's important to remember the purpose of this treatment.The goal is not to allow people to eat peanuts freely," said Daniel Adelman, MD in chief of Aimmune. "The children come out every morning and their parents worry. It is the day they will be exposed to peanuts and risk their lives; the goal of this treatment is to help protect people against these potentially lethal effects. reactions. "
Aimmune will expand its approach to other food allergies, checking if a similar drug could help desensitize children to egg allergies next year.
Experts have warned that this type of diet should not be started at home.
In the United States, an estimated 6 million children are suffering from food allergies. In an accompanying editorial, Michael Perkin, of the Population Health Research Institute at St. George's University in London, pointed out that the potential market for a therapy is several billion dollars. Aimmune was a defatted peanut flour manufactured according to the rigorous manufacturing processes required for pharmaceuticals. Adelman pointed out that it was free of variability that could result in the risk of delivering the wrong dose.
Keet said that one of the concerns was whether parents and children would understand the limitations of the drug.
"We would always ask patients to review the labels and not ingest anything peanut," said Keet. "We do not know what people would end up doing with this partial protection – it could give people a false sense of security."
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