patch that experts say could be a breakthrough treatment for
peanut-allergy sufferers appears to be both safe and
effective, according to an early stage clinical trial that
involved Seattle-area children, among others, to test the
potentially lifesaving technology.
Viaskin Peanut patch made by the French biotech firm DBV
Technologies boosted the amount of peanut protein it took to
elicit an allergic reaction by at least 10-fold, particularly
in kids younger than 12.
according to the first results of a multicenter, gold-standard
clinical trial presented recently at the annual meeting of
American Academy of Allergy, Asthma and Immunology in Houston,
trial tested whether an immunotherapy patch can effectively
desensitize allergy sufferers by administering small amounts
of peanut protein into the outer layers of the skin,
activating an immune response, but without releasing antigens
into the bloodstream, where they trigger allergic shock.
they wanted was to find out, on average, if patients could
tolerate at least 10-fold as much peanut protein after being
on the patch as before being on the patch," said Dr.
Stephen Tilles, a physician partner at Northwest Asthma &
Allergy Center in Seattle, which oversaw 11 area participants.
novel treatment that poses fewer challenges — and dangers
— than allergy shots or oral immunotherapy, in which
sufferers eat small amounts of reaction-producing foods to
desensitize their bodies to the triggers, Tilles said.
11-year-old Spencer Baty of Issaquah, one of the participants
in the peanut-patch trial, the test has been a success. He
went from having an allergic reaction to as little as
one-tenth of a peanut to having a reaction only when exposed
to 10 peanuts — or more.
could mean the difference between having — or avoiding — a
potentially fatal reaction, said Lisa Geschke Sawyer, a
spokeswoman for the Seattle Food Allergy Consortium, or SeaFAC,
which works to bring allergy-related clinical trials to
biggest fear is to get something with a little bit of (an
allergen) in it," said Sawyer, whose own son is allergic
to cashews and pistachios. "It’s a big deal to have
this here now."
double-blind trial included 221 participants ages 6 to 55 —
113 of them under age 12 and 73 ages 12 to 17 — at sites in
the U.S., Canada, France, the Netherlands and Poland. They
were tested to see how much peanut protein it took to elicit a
reaction, and then asked to wear adhesive patches infused with
doses of 50, 100 or 250 micrograms of peanut protein. After a
year they were tested again to see if their reaction
thresholds were higher.
250-microgram patch, the highest dose, was the most effective,
according to the study led by Dr. Hugh Sampson, a professor of
pediatric allergy and immunity at the Mount Sinai Hospital in
New York. In children ages 6 to 11, more than 53 percent
responded to the infused patch, versus less than 20 percent
who responded to a placebo. Significantly, none of the
participants required epinephrine injections to stop allergic
reactions, indicating that the patch is safe, Tilles said.
results are encouraging, said Dr. James Baker, chief executive
of Food Allergy Research & Education, or FARE, an advocacy
million people in the U.S. have food allergies, and the rate
of peanut allergies among children tripled between 1997 and
2008, according to the Centers for Disease Control and
is a crucial time to accelerate the development of new
therapeutics," Baker said.
step is a Phase III clinical trial, the final hurdle before
submitting the product for consideration by the federal Food
and Drug Administration. If all goes well, the product could
be available in 2018, Tilles said.
recent Phase IIb trial lasted a year, but Spencer’s father,
David Baty, 53, said the boy was accepted into a two-year
extended program in which he’ll continue applying the peanut
patches to his back every day. The family would have
participated in the trial simply in the interest of advancing
science, but the benefit for Spencer has been remarkable, the
like having the bit of cushion that I have," Spencer
said. "If I eat something, it’s not the end of the