A large study provides a strong evidence that children and teenagers can be desensitized to peanut allergies through controlled, controlled exposure to drugs. drugs.
After a year of treatment with an experimental drug made by Aimmune Therapeutics, 67 percent of children and teenagers with peers allergies were able to safely ingest the equivalent of at least two people, compared with just 4 percent of those on placebo, according to the study published in the New England Journal of Medicine.
But that improved a lot of people from the drug, a pharmaceutical grade preparation for flour, had an adverse event of some type, and with one in 10 with a trial from the trial due to gastrointestinal, skin or respiratory problems or systemic allergic reactions.
For years, smaller studies have suggested that exposure to allergens could desensitize people to the potentially life-threatening effects of exposure, which can include anaphylactic shock, but several large experts, a systematic study of 550 people could lead to the first treatment approved by the Food and Drug Administration. The participants were between ages 4 to 17, the group in which researchers found the drug to be effective.
"I think that is going to be going from right now where there is no approved treatment for food allergy, maybe a landscape, in a few years, we have a couple of options to offer our patients," said Corinne Keet , a pediatric allergist at the Johns Hopkins School of Medicine not involved in the study, and who said that it would be "sea change" given the dearth of options today. "In the short-term, the products that come to market are not cures, but I think there are more of a curative treatment goals. And overall, the goal is more."
Aimmune, which is funded by the study, plans to submit an application for the federal regulators next month and it is expected to be launched late in 2019. It is not clear how many patients would have to take it, and whether it would would be covered by insurance.
"For now, the advice will be for ongoing treatment," said Wayne Shreffler, director of the Food Allergy Center at the Massachusetts General Hospital and one of the authors who had received trial funding and fees from Aimmune. "Further studies will be needed to address whether after some years, some people can alter regular dosing. The large majority of study participants are tolerated the treatment, and I expect the same will be true of its use in the 'real world' when and if it's approved. "
The treatment is not a cure, and the regimen may not appeal to everyone with food allergies. Patients came to a clinic every two weeks to have their dose, increased under supervision, over a period of six months. They also shop the drug at home daily.
"I think it's important to remember what the treatment is – the goal isn't to allow people to freely eat peanuts," said Daniel Adelman, the chief medical officer of Aimmune. "Kids go out every door every morning, and their parents worry, this will be exposed to life and threatening reactions; the goal is to help protect people from those that are potentially life-threatening reactions. "
Aimmune will expand the approach to food allergies, testing whether a similar drug can work to children allergic next year.
Experts warned that this kind of regimen should not be started at home.
There are an estimated 6 million children with food allergies in the United States. In accompanying editorial, Michael Perkin, from the Population Health Research Institute at St. George's University of London pointed out that the potential market for therapy is billions of dollars. The Aimmune drug was defatted by the rigorous manufacturing processes required of pharmaceutical products, which was emphasized to mean that it could carry out the danger of delivering the wrong dose.
The keet said is that parents and children will understand the limits of the drug.
"We'd still be asking patients to review the labels, and not ingest anything with peanut in them," Keet said. "We don't know what people would end up doing with this partial protection may give people a false sense of security."