An experimental skin patch called Viaskin is showing promise to treat toddlers who are highly allergic to peanuts — training their bodies to handle an accidental bite.
If proven, it would fill a big void.
Peanut allergy is one of the most common and dangerous food allergies, with exposures able to quickly can turn birthday parties and play dates into emergency room visits.
There is no cure, and the only treatment is for children 4 and older, who can consume a special peanut powder to protect against a severe reaction.
Now, the experimental patch aims to deliver that kind of treatment through the skin instead.
In a major test involving children 1 to 3 years old, it helped those who couldn’t tolerate even a small fraction of a peanut to eventually safely eat a few, researchers reported in the New England Journal of medicine.
If additional testing pans out, “This would fill a huge unmet need,” said Dr. Matthew Greenhawt, an allergist at Children’s Hospital Colorado who helped lead the study.
About 2% of children in the United States are allergic to peanuts, some so severely than even a tiny amount can cause a life-threatening reaction.
Their immune system overreacts to peanut-containing foods, triggering an inflammatory cascade that causes hives, wheezing or worse. Some outgrow the allergy, but most must avoid peanuts for life and carry rescue medicine to stave off a severe reaction if they accidentally ingest some.
The federal Food and Drug Administration approved the first treatment to induce tolerance to peanuts in 2020. That was an oral immunotherapy called Palforzia that 4- to 17-year-olds can consume daily to keep up the protection.
Also, Aimmune Therapeutics’ Palforzia is being tested in toddlers. And France’s DBV Technologies is pursuing skin-based immunotherapy as an alternative way to desensitize the body to allergens.
The Viaskin patch is coated with a small amount of peanut protein that’s absorbed into the skin. A daily patch is worn between the shoulder blades, where toddlers can’t pull it off.
In the new study, 362 toddlers with peanut allergy first were tested to see how high a dose of peanut protein they could tolerate. Then, they were randomly assigned to use the Viaskin patch or a lookalike dummy patch every day.
After a year of treatment, they were tested again. This time, about two-thirds of the toddlers who used the real patch could safely ingest more peanuts — the equivalent of three to four, researchers concluded.
That compares to about a third of the kids given the dummy patches. Greenhawt said they likely include children who are outgrowing the allergy.
Four Viaskin recipients experienced an allergic reaction called anaphylaxis that was deemed related to the patch. Three were treated with epinephrine to calm the reaction, and one dropped out of the study.
Some kids also accidentally ate peanut-containing foods during the study, and the researchers said allergic reactions were less frequent among the Viaskin users than those wearing the dummy patches. The most common side effect was skin irritation at the patch site.
The results “are very good news for toddlers and their families as the next step toward a future with more treatments for food allergies,” Dr. Alkis Togias of the National Institutes of Health, which wasn’t involved with the study, wrote in an editorial that accompanied the report on the findings.
Togias cautioned that it’s too early to compare oral and skin treatments, but pointed to data suggesting each might have different pros and cons — raising the possibility that oral therapy might be stronger but also cause more side effects.
DBV Technologies has struggled for years to bring the peanut patch to market. Last month, the company said the FDA wants additional safety data for toddlers, and a separate study already is tracking longer treatment. A study of 4- to 7-year-olds also is underway.