The first medical treatment for children with peanut allergy will probably be approved next year, but there are concerns about their accessibility, even though essentially consisting of peanut flour.
A study in the US and Evelina Children's Hospital in the UK shows that gradually increasing a small initial dose of peanut protein for six months allowed two thirds of children to eat two peanuts without harmful effects. The article, published in the New England Journal of Medicine, follows a similar, smaller study in Cambridge, UK four years ago.
The latest results are from scientists funded by Aimmune Therapeutics, which was launched to investigate this treatment for peanut allergies. They believe they will get approval for their treatment, delivered in a capsule that is opened and sprinkled with food in the middle of next year.
The difference between testing a treatment that they call AR101 in 550 children and those who were before "is the rigor with which the whole process was performed," said allergist Dr. Stephen Tillis, a professor at the University of Washington in Seattle and co -author. of the study.
"It is a pharmaceutical grade treatment product. It's not just peanut flour you can buy somewhere. " It is, he said, "a note that the FDA [Food and Drug Administration, which licences drugs in the US] here I would be satisfied with ".
The children in the study received three-phase treatment, starting at a very low dose, which was increased every two weeks for at least 20 weeks, with daily dosing at home throughout the period, up to 12 months.
Most children who participated in the study started with a reaction to something beyond 10mg of peanut protein – an American peanut contains about 300mg and a smaller peanut from the UK, about 160mg. At the end of the trial, the median tolerated amount was 1000 mg, or about four peanuts. "For me this is surprising," said Tilles.
Scientists believe that children will have to continue to eat peanut protein to stay safe, possibly for a lifetime. Peanut allergy is a potential killer. Earlier this month, owners of a takeaway restaurant in Lancashire were arrested because of the death of 15-year-old Megan Lee who suffered an asthma attack after eating foods widely contaminated with peanut protein. Two years ago, Natasha Ednan-Laperouse died after eating a Pret sandwich containing sesame seeds.
This makes peanut allergy treatment very necessary and potentially highly profitable. Tillis says their treatment will not be priced as a biological treatment – which is extremely expensive. "It will not be tens of thousands of dollars, but funded as an innovative new drug," he said.
Peanut allergy emerged in the 1990s and now affects more than 100,000 children in the UK – about one in 50 – and more than 1.5 million in the US. It is estimated that the market for a treatment could be $ 4.8 billion a year.
In Cambridge, dr. Andrew Clark and his colleagues, whose work from the Lancet in 2014 has generated great enthusiasm, are also working towards a treatment that should come out in a few years. "We marketed that," Clark said. He says he expects his to be smoother, pointing out that 20% of children dropped out of the AR101 study, including 12% because of the side effects.
Since their report, they have treated 180 patients in particular because the NHS does not fund it. Only four gave up, he says. Your treatment, now costing around £ 17,000 per child, will probably not be much cheaper than the AR101, but it does include the costs for staff and hospital involved in the safe treatment of children.
Doctor Michael Perkin, an honorary consultant for pediatric allergies at St. George's Hospital in London, says in an editorial at NEJM that it is salutary to remember that the treatment used at Cambridge was "a sack of peanut meal costing peanuts."
"It's not like it was a miracle drug that was raised with a monoclonal antibody in some smart lab. They have exactly the same peanut flour and put it inside a capsule," he told The Guardian.
But there are dangers in trying to desensitize a child at home. "The ability to shell out the right amount of peanuts or buy a sack of peanut flour to do so will be fraught with potential risks. If a parent's hand falters, it may end up with 10, 20 or 50 times the dose and trigger a significant reaction, "he said.
This may mean that families will find the money to put their children in the first six months with a licensed treatment – and then buy peanuts to keep them protected.
"This is certainly a scenario," said Tillis. Small groups in the US were already doing what he called "off-label peanut immunotherapy" – treatment with something that does not have a medical license. "Many of these patients end up with some food bought in stores." But he added: "We do not know if this is the equivalent of the maintenance dose of AR101."