By Carolyn Y. Johnson, The Washington Post
An ample study provides the strongest evidence that children and adolescents may be desensitized to peanut allergies by controlled exposure and escalated to a substance that could otherwise trigger a life-threatening reaction – an advance that specialists said could to announce the development of a new drug food allergy.
After one year of treatment with an Aimmune Therapeutics drug, 67% of children and adolescents with peanut allergens could safely ingest the equivalent of at least two peanuts, compared with only 4% of those who received placebo, according to the study published in the New England Journal of Medicine. But this improvement came at a cost – almost all study participants who received the drug, a pharmaceutical preparation of peanut meal, suffered adverse events of one type and one in ten retired from the study due to gastrointestinal, cutaneous or respiratory problems or systemic allergic reactions.
For years, smaller studies have suggested that exposure to escalated amounts of peanut allergens could desensitize people to the potentially life-threatening effects of exposure, which may include anaphylactic shock, but more external experts have said that the vast, systematic study of 550 people could lead to the first treatment approved by the Food and Drug Administration. The majority of participants were ages 4 to 17, the group in which the researchers found that the drug was effective.
"I think we are looking at the transition from the moment that there is no approved food allergy treatment, in a landscape where we probably will, in a few years, have some options to offer our patients," said Corinne Keet, an allergologist pediatrician at the Johns Hopkins School of Medicine who was not involved in the study and said that it would be a "big change" given the lack of options today. "In the short term, products that can come into the market are not treated, but I think there are a number of different approaches that are explored – and overall, the goal is more curative."
Aimmune, who funded the study, plans to file a drug application with federal regulators next month and expects it to launch by the end of 2019. It is unclear how much it costs as long as patients should take it and if it was covered by insurance.
For the time being, advice will be on ongoing treatment, "said Wayne Shreffler, director of the Center for Food Allergies at Massachusetts General Hospital and one of the authors of the study, who received court fees and fees from Aimmune. "Further studies will be needed to address whether some people can change their regular doses after a few years. The vast majority of study participants have tolerated treatment and expect the same with regard to use in the" real world "when and if approved. "
Treatment is not a cure, and the scheme can not appeal to everyone with food allergies. The patients came to a clinic every two weeks for their dose to gradually increase under supervision for a period of six months. They also took the medicine at home every day.
I think it is important to remember the purpose of this treatment – the goal is not to allow people to eat peanuts, "said Daniel Adelman, Aimmune's medical director." Children go out every morning and their parents worry on the day they are exposed to peanuts and may have a life-threatening reaction; the purpose of this treatment is to help protect people from those potentially dangerous for their life reactions. "
Aimmune will expand the approach to other food allergies, testing whether a similar medicine could work to desensitize children to egg allergies next year.
Experts have warned that this type of regime should not be initiated at home.
There are about 6 million children with food allergies in the United States. In an accompanying editorial, Michael Perkin, of the University of St. Louis University's Population Research Institute. George of London, stressed that the potential market for a therapy is billions of dollars. Aimmune was a skimmed-milk powder made through the rigorous manufacturing processes required by pharmaceutical products, which Adelman pointed out that was devoid of variability that could lead to the danger of giving the wrong dose.
Keet said that a concern is whether parents and children would understand the limits of the drug.
"We still want to ask patients to review the labels and not eat anything with peanuts," Keet said. "We do not know what people with this partial protection would do – it could give people a false sense of security."
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