If approved, a new treatment for peanut allergy may enable kids to eat small amounts of peanuts without a severe allergic reaction.
For children with a peanut allergy, every bite of food outside the home stirs up anxiety.
Exposure to trace amounts of peanuts in cookies, cakes, or other foods from cross contamination can end with a severe allergic reaction and even hospitalization.
The results of a new study may lead to the approval of a new treatment that reduces the risk of these kinds of potentially deadly reactions, providing relief not just for children, but also for their parents.
The treatment is not a cure for peanut allergy. Nor is it designed to allow kids to eat entire peanut butter and jelly sandwiches. Instead, the goal is to allow them to tolerate small amounts of peanuts.
“Being able to safely eat one or two peanuts is a huge improvement in terms of kids’ quality of life — such as when they go to a friend’s house overnight or to a potluck, and they’re avoiding peanuts but could still accidentally ingest a small amount,” said Dr. Stephen Tilles, one of the study’s co-authors and past president of the American College of Allergy, Asthma, and Immunology.
For many kids with a peanut allergy, this is enough protection.
“Some children don’t ever want to eat food with peanuts. They just want to be protected in case they get exposed to it,” said Dr. Tina Sindher, a clinical assistant professor at the Sean N. Parker Center for Allergy & Asthma Research at Stanford University, who was not involved in the study.
The results of the research 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 every day for sixth months, starting with minute amounts. This was followed by six months at a “maintenance dose,” the equivalent of one peanut daily.
This type of treatment is known as oral immunotherapy and is designed to build up the immune system’s tolerance to an allergen.
After one year, over two-thirds of these 4- to 17-year-olds were able to consume 600 milligrams of peanut protein — the equivalent of two peanuts — during a food challenge “with no more than mild symptoms.”
In contrast, only 4 percent of 124 children who had been taking a non-peanut powder throughout the study — the placebo group — were able to tolerate the same amount of peanut protein.
Half of the children in the treatment group were also able to safely consume 1,000 milligrams of peanut protein during the food challenge.
This treatment, though, may not work for everyone.
Almost all of the children experienced some adverse reactions during the study. The most common ones in children taking the peanut protein were gastrointestinal pain, vomiting, nausea, itchy skin, coughing, and irritation of the throat.
About one-third of children in the treatment group had only mild symptoms, compared to 50 percent in the placebo group.
Severe side effects occurred in 4.3 percent of kids in the treatment group and less than 1 percent of kids in the placebo group.
In addition, during the study, 14 percent of children in the treatment group received injections of epinephrine for a severe allergic reaction, compared to 6.5 percent of the children in the placebo group.
Certain side effects were bad enough that some children dropped out before the end of the study — almost 12 percent of children in the treatment group. Sindher is not surprised at this high dropout rate.
“We see this all the time in the clinic,” she said. “Some kids do not tolerate oral immunotherapy. For example, some have an anaphylactic reaction on a dose they’ve been taking for two or three weeks in a row. There’s a lot of variability in the real world.”
Unfortunately, it’s not possible to predict which children will have bad reactions.
“It’s hard to know who will be on the treatment 1 or 2 years later,” said Tilles. “But this trial suggested, at least after a year of therapy, that there’s a large proportion of patients still doing well.”
While the study made headlines among the allergy community, there were a few caveats. 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 reported that 5 of the 13 main authors are employees of Aimmune Therapeutics. The others are paid to serve on the company’s scientific advisory board.
The treatment still needs approval from the U.S. Food and Drug Administration before it will be available in the clinic. But there’s likely to be a big demand for it.
According to the Food Allergy Research & Education website, the rate of peanut or tree nut allergy among U.S. children more than tripled between 1997 and 2008.
About 40 percent of children with food allergies have experienced a severe allergic reaction such as anaphylaxis.
This isn’t the only potential treatment for dangerous and deadly food allergies being researched.
Multiple treatments for peanut and other food allergies are currently under development. Sindher said many of these are designed to help children tolerate oral immunotherapy.
DBV Technologies has submitted an application to the FDA for an immunotherapy patch that delivers very small amounts of peanut to the skin — micrograms, not milligrams.
Sanofi is working on an immunotherapy that is delivered under the tongue. In addition to the peanut protein, this includes a compound that may increase the immune system’s tolerance to peanut allergens.
Another treatment being tested uses omalizumab — the allergy medicine Xolair —alongside immunotherapy. This drug blocks an antibody involved in the peanut allergic reaction.
Stanford researchers are also testing a DNA vaccine that may reduce the body’s inflammatory response to peanuts. The vaccine also doesn’t include the actual peanut proteins, so the risk of an anaphylactic reaction during treatment is lower.
Sindher doesn’t think so.
“If anything, we’re seeing the incidence of peanut allergies going up every year,” she said. “But we are coming up with more treatments. We are also trying to learn more about food allergies to help with prevention strategies.”
One 2015 study found that introducing some infants to peanuts early on may reduce their risk of developing a peanut allergy.
These treatments may offer children more options than just “avoid, avoid, avoid” and carrying two EpiPens everywhere they go.
“If the treatments work, children will be protected when they eat the equivalent of one peanut,” said Sindher. “This is what we call ‘bite-proof.’ If a kid accidentally gets a bite of a cookie with peanuts in it, they’re not going to need to be rushed to the hospital.”
There’s one line of research, though, that may drastically reduce the need for these kinds of treatments — genetically engineering a hypoallergenic peanut, something researchers are working on right now.