The first treatment to help prevent serious allergic reactions to peanuts may be on the way. A California company said Tuesday that its daily capsules of peanut flour helped children build tolerance to the nuts in a major study.
Millions of children have peanut allergies, and some have life-threatening reactions if accidentally exposed to the nuts. Doctors have been testing daily doses of peanut flour, contained in a capsule and sprinkled over food, as a way to prevent that by gradually getting them used to very small amounts.
Aimmune Therapeutics, based in Brisbane, Calif., said 67% of children who had its treatment were able to tolerate the equivalent of roughly two peanuts at the end of the study, compared with only 4% of those given a placebo powder.
But a big warning: Don't try this at home.
"It's potentially dangerous," said Dr. Stacie Jones, a University of Arkansas allergy specialist. "This is investigational. It has to be done in a very safe setting" to make sure kids can be treated quickly for any bad reactions that occur, she said.
Jones helped lead the study, consults for the company, and will give the results at an allergy conference next month. The results have not yet been reviewed by independent experts.
The study involved nearly 500 children ages 4 to 17 with peanut allergies so severe that they had reactions to as little as a tenth of a peanut. They were given capsules of either peanut flour or a placebo powder in gradually increasing amounts for six months, then continued on that final level for another six months. Neither the participants nor their doctors knew who was getting what until the study ended.
About 20% of the kids getting the peanut powder dropped out of the study, 12% because of reactions or other problems. The product showed "overall good safety," Jones said.
Dr. Andrew Bird is an allergy specialist at the University of Texas' Southwestern Medical Center in Dallas who also consults for Aimmune and had patients in the study. He said the treatment doesn't enable children to eat peanuts as if they had no allergy, but the research suggests that being able to tolerate at least one peanut should protect 95% of them from having a reaction if they are exposed to peanuts.
That would be a relief to Cathy Heald, a Dallas woman whose 10-year-old son Charlie was in the study.
"We had to teach him that he has to ask about everything he eats from a very early age," she said. "He's described it as living in a cage, watching other people get to eat what they want."
Charlie was assigned to the group given the placebo in the study but has been able to get the real thing since it ended, she said.
Aimmune plans to seek U.S. Food and Drug Administration approval for the treatment later this year and in Europe early next year.
The company's chief executive has said he expects the first six months of treatment to cost $5,000 to $10,000, then $300 to $400 a month after that.
The thinking about peanut allergies has changed in recent years, and experts now think early exposure helps prevent those allergies from forming. Last year, the National Institutes of Health issued new advice, saying most babies should get peanut-containing foods starting around 6 months, in age-appropriate forms such as watered-down peanut butter or peanut puffs — not whole peanuts because those are a choking hazard.
Aimmune's stock initially jumped after the news, then dropped sharply before recovering somewhat. Around 11 a.m. Pacific time, the shares were down more than 3%. Adam Feuerstein, a columnist with healthcare news site Stat News, said on Twitter that the company's valuation had been high and that there remains a question about whether parents will have their children undergo the treatment, given the possibility of adverse reactions such as anaphylaxis.
11:15 a.m.: This article was updated with comments from Dr. Stacie Jones, Dr. Andrew Bird and Cathy Heald, as well as additional details.