If approved, a new peanut allergy treatment may allow children to eat small amounts of peanuts without a severe allergic reaction.
For children with peanut allergy, any bite of food outside the home gives rise to anxiety.
Exposure to peanuts in biscuits, cakes or other cross-contamed foods may result in a severe allergic reaction and even hospitalization.
The results of a new study can lead to the approval of a new treatment that reduces the risk of such potentially lethal reactions by providing relief not only to children but also to their parents.
Treatment is not a cure for peanut allergy. Nor is it intended to allow children to eat whole peanut butter and jelly sandwiches. Instead, the goal is to allow them to tolerate small amounts of peanuts.
"Being able to eat one or two peanuts safely is a tremendous improvement in children's quality of life – such as when they go to a friend's house at night or throat and avoid peanuts, but they can accidentally swallow a small sum, "said Dr. Stephen Tills, one of the co-authors of the study and former president of the American College of Allergy, Asthma and Immunology.
For many children with peanut allergy, this is enough protection.
"Some children never want to eat peanuts, they just want to be protected if they're exposed to them," said Dr. Tina Sindler, clinical assistant at Sanford Parker's Allergy and Asthma Research Center at Stanford university that did not participate in the study.
The results of the study were presented Sunday at the American College of Allergy, Asthma and Immunology in Seattle and published Monday in The New England Journal of Medicine.
In the study, 372 children with a known peanut allergy consumed an increasing amount of peanut protein each day for six months, starting with small amounts. This is followed by six months at a "maintenance dose," equivalent to one peanut daily.
This type of treatment is known as oral immunotherapy and is designed to build tolerance of the immune system to the allergen.
After one year, over two-thirds of these 4- to 17-year-olds were able to consume 600 milligrams of peanut protein, equivalent to two peanuts, during a nutritional challenge with "no more than mild symptoms".
In contrast, only 4% of 124 children who took powder without dust during the study – the placebo group – were able to tolerate the same amount of peanut protein.
Half of the children in the treatment group are also able to safely consume 1000 milligrams of peanut protein during the nutritional challenge.
This treatment, however, may not work for all.
Almost all children had some side effects during the study. The most common in children taking peanut protein are gastrointestinal pain, vomiting, nausea, itchy skin, coughing and throat irritation.
About one third of the children in the treatment group had only mild symptoms, compared with 50% in the placebo group.
Severe adverse reactions occurred in 4.3% of children in the treatment group and less than 1% of children in the placebo group.
In addition, during the study, 14% of children in the treatment group injected epinephrine for a severe allergic reaction, compared with 6.5% of the placebo group children.
Some side effects were bad enough that some children gave up before the end of the study – almost 12% of the children in the treatment group. Sindler is not surprised by this high bust rate.
"We see this all the time in the clinic," she said. "Some children do not tolerate oral immunotherapy, for example, some of them have an anaphylactic reaction to the dose they take for two or three consecutive weeks, and there are many variations in the real world."
Unfortunately, it is not possible to predict which children will have bad reactions.
"It's hard to know who's going to be treated 1 or 2 years later," Tils said. "But this study suggests, at least after a year of therapy, that a large proportion of patients still do well."
While the research made headlines among the community of allergies, there were several warnings. The protein powder used in the study, known as AR101, was developed by Aimmune Therapeutics, which designed and sponsored the clinical trial. The New York Times reports that 5 of the 13 major authors are employees of Aimmune Therapeutics. Others are paid to work in the company's scientific council.
Treatment still needs approval from the US Food and Drug Administration before being available at the clinic. But there is likely to be a great demand for it.
According to the Food Allergy Research and Education website, the incidence of peanuts and shellfish allergy among US children has tripled between 1997 and 2008.
About 40% of children with food allergies have had a severe allergic reaction such as anaphylaxis.
This is not the only potential treatment for dangerous and deadly food allergies that are being studied.
Numerous treatments for peanuts and other food allergies are currently being developed. Sindler said many of these are designed to help children tolerate oral immunotherapy.
DBV Technologies filed an application with the FDA for an immunotherapy patch that delivers very small amounts of peanuts to the skin – micrograms instead of milligrams.
Sanofi works on immunotherapy, which is delivered under the language. In addition to peanut protein, this includes a compound that can increase the tolerance of the immune system to peanut allergens.
Another tested treatment uses omalizumab – the drug for Xolair allergy – along with immunotherapy. This drug blocks an antibody involved in the peanut allergic reaction.
Stanford researchers also tested a DNA vaccine that can reduce the body's inflammatory response to peanuts. The vaccine also does not include actual peanut proteins, so the risk of an anaphylactic reaction during treatment is lower.
Sindler does not think so.
"If not, we see the frequency of peanut allergies increases every year," she said. "But we come with more treatments. We also try to learn more about food allergies to help with prevention strategies. "
A 2015 study found that introducing some babies to peanuts at first may reduce the risk of peanut allergy.
These treatments can offer children more opportunities than simply "avoid, avoid, avoid" and carry two EpiPens everywhere they go.
"If the treatment works, children will be protected when they eat the equivalent of a peanut," said Sidder. "This is what we call" proof of bite. "If a child accidentally gets a bite from a peanut cookie, he will not have to rush to the hospital.
There is, however, a line of research that can drastically reduce the need for such treatments – the genetic engineering of hypoallergenic peanut, something the researchers are currently working on.