A large study provides the strongest evidence that children and adolescents may be desensitized to peanut allergies through controlled, exponential exposure to a substance that could otherwise induce a life-threatening reaction – a move that experts have said are likely to announce the development of new food allergies drugs.
After one year of treatment with Aimmune Therapeutics, 67 percent of children and adolescents with peanut allergy were able to safely use the equivalent of at least two peanuts, compared to just 4 percent of those who received placebo, according to a study published in the New England Journal of Medicine.
But this improvement was achieved at a price – almost all study participants who received the drug, a peanut-based pharmaceutical product suffered adverse events of some type and one out of ten resigned from the study due to gastrointestinal, skin or respiratory illness problems or systemic allergic reactions.
For years, smaller studies have concluded that exposure to increasing amounts of peanut allergens could make people astonish the potentially life-threatening effects of exposure, which may include anaphylactic shock, but several external experts have said that a large, systematic study of 550 people could lead to first treatment approved by the Food and Drug Administration. Most participants were aged 4 to 17 years old, a group in which researchers found the drug to be effective.
"I think we are looking at the fact that from now on we will not have approved food allergy treatment in a country where it is likely to offer our patients a few options within a few years," said Corinne Keet, a pediatric allergy at Johns Hopkins School of Medicine , who did not participate in the study, and said it would mean "changing the sea" due to the lack of options today. "In the short term, products that can be marketed are not medicines, but I think there are a number of different approaches that are being studied – and overall, the goal is better."
Aimmune, who funded the study, plans to file a treatment request with the federal regulators next month and expects it to begin by the end of 2019. It is unclear how much it would cost, how long patients would have to take, and whether they would be insured.
"For the time being, the council will continue to treat," said Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital and one of the study's authors who received trial funding and fees from Aimmune. "There will be a need for further studies to decide whether after a few years some people may change their regular dosing." The vast majority of study participants tolerated treatment, and I expect it to be the same as in the "real world" when and when approved.
Treatment is not a cure and the regimen does not have to appeal to everyone with food allergies. The patients came to the clinic every two weeks to gradually increase their dose under supervision for six months. They also used the drug at home.
"I think it's important to remember the goal of this treatment – the goal is not to allow people to eat peanuts," said Daniel Adelman, chief physician at Aimmune. "Children come out of the door every morning and their parents are afraid they will be exposed to peanuts and potentially life-threatening reactions." The goal of this treatment is to help protect people from potentially life-threatening reactions.
Aimmune is expanding access to other food allergies, testing whether a similar drug could help childhood anaesthetizing children in the next year.
Experts have warned that this kind of regime should not be triggered at home.
It is estimated that 6 million children with food allergies in the United States. Michael Perkin of the Research Institute for Human Health Research at the University of St. Louis, George in London pointed out that the potential market for therapy is billions of dollars. The treatment of Aimmune was the defatted peanut flour produced through the strict manufacturing processes required for pharmaceutical products, emphasized by Adelman, meaning that it is not simple variability that could lead to the risk of getting a bad dose.
Keet said one of the issues is whether parents and children will understand the drug boundaries.
"We would still ask patients to review the labels, and not catch anything with peanut oil," Keet said. "We do not know what people would eventually do with this partial protection – it can give people a false sense of security."