year, Americans make 30,000 emergency room visits because of
food allergies, according to the Food and Drug Administration.
touching a surface that previously held peanuts can trigger
anaphylaxis, a life-threatening allergic reaction. When a
peanut-allergic person starts feeling their throat close up,
they stab themselves with an epinephrine, or adrenaline,
device and then head to the ER for a few hours of monitoring.
there was another way?
doctors and pharmaceutical companies are trying to make people
less allergic to peanuts. A peanut pill and a patch could be
widely available by the end of 2019.
the meantime, a small number of private-practice allergists
have been offering oral immunotherapy, in which you gradually
eat more peanut products under a doctor’s supervision.
now, the majority of allergists only prescribe patients an
epinephrine device and tell them to strictly avoid peanut
protein, in hopes of warding off reactions such as hives,
swelling, blood pressure loss and difficulty breathing. The
FDA has not approved any treatments for peanut allergies,
which affect 2 percent of children today.
spring, Aimmune Therapeutics announced that it had wrapped up
a 10-nation trial for its "peanut pill," AR101. Of
the 69 trial sites, two were in North Carolina: the Food
Allergy Institute at UNC-Chapel Hill and a private practice,
Allergy and Asthma Partners in Charlotte.
hope all the time is to make a cure, to make this go away
permanently and never have to worry about it," said Dr.
Edwin Kim, a researcher at the Food Allergy Institute and the
father of a peanut-allergic child. "These kids don’t
want to think about it. They don’t want to have to worry
about it. They want to be normal."
decades, people with "hay fever" or other
environmental allergies have received allergy shots.
Allergists inject you with increasing amounts of serum derived
from whatever you’re allergic to, building up your tolerance
for the allergen. You start twice a week and stretch out the
time between injections. After several years, you’ll no
longer need the shots.
we found out in the ‘80s and ‘90s was that doing something
similar, like putting peanuts into an allergy shot, wasn’t
effective," Kim said. "That’s where the idea of
oral immunotherapy was born, since eating the food is how your
body learns to tolerate it."
immunotherapy, or OIT, works the same way the allergy shots
do: slowly up your tolerance for the allergen, until you no
longer have allergic reactions to it. You start with a very
small amount of the food, check to make sure you don’t have
any reactions, and then gradually increase that amount in a
process called updosing.
Wesley Burks at Duke University first demonstrated how to
increase patients’ tolerance to peanuts in 2009. His 29
patients then started with mixing a few crumbs of peanut flour
into applesauce or pudding, then updosed for months by eating
a little more each day to build up tolerance for the allergen.
they passed a "food challenge" of eating about 16
peanuts at once, the patients entered maintenance, which meant
they ate eight peanuts a day for years afterward. Every OIT
study since then has followed a similar updose and maintenance
pattern, with some including the food challenge.
TO THE PEANUT PILL
a parent-run nonprofit brought together representatives from
the National Institute of Health, the FDA, pharmaceutical
companies and academic centers including Duke to figure out
how to cure food allergies. Aimmune formed from that meeting.
asked: ‘What will it take to get a treatment approved for
food allergies?’ " said Dr. Daniel Adelman, Aimmune’s
chief medical officer. "We needed a high quality,
reproducible, reliable product, and there was no such thing at
the company created AR101, capsules of proprietary peanut
flour that come with a standardized updose and maintenance
schedule. As in the 2009 Duke study, patients mix the peanut
product with food and eat it. Aimmune has tested AR101 on more
than 1,000 patients.
end of this year, Aimmune will apply to the FDA for a license
to sell AR101 in the U.S., Adelman said.
same time, another company hopes to offer a "peanut
patch," called Viaskin, which patients will wear for
increasing amounts of time to updose and then will wear all
the time for maintenance.
has moved to the Food Allergy Institute at UNC, where
researchers are also working on peanut "drops" held
under the tongue, Kim said. No pharmaceutical company has
picked up the drops yet, so they will not be available for
consumers for at least several more years.
pass, AR101 and Viaskin will be the first FDA-approved
products to treat peanut allergies.
Elias Kroboth of Raleigh was a baby, he broke out in full-body
hives when his brother ate a peanut butter sandwich across the
table. So after Elias turned 2, he started OIT with a private
allergist who had worked on the Duke studies. Over the past
three years, he updosed from crumbs per day to his maintenance
level, when he eats five to eight peanuts per day and then
rests for two hours to watch for a reaction.
mother, Kira Kroboth, said they worked closely with Elias’
allergist. When Elias’ immune system was fighting off colds
from the rest of the family or travel, she texted the
allergist to ask how much to lower his daily dose. It took her
several tries to find an allergist who offered OIT instead of
only preaching strict avoidance.
was no other option besides ‘here’s an EpiPen, good luck,’
" Kroboth said. "When we had that first appointment
when he ate three tiny breadcrumbs of peanut, I felt OK, like
we were doing something about this. Each updose was
thriving parent network helps families find the rare
allergists who offer OIT. The website OIT 101 (www.oit101.org)
lists just over 100 private practice allergists nationwide,
out of around 5,700 allergists certified by the American Board
of Allergy and Immunology. The website emphasizes that
patients should not attempt to do OIT themselves and says that
it only lists vetted allergists who offer OIT.
22 private-practice board-certified allergists in the Triangle
and 21 in Charlotte, Kroboth said only three offer OIT.
Eligible patients may enter the pill, patch or drop trials at
UNC and in Charlotte, but Elias wasn’t the right age when
the trials began.
get frustrated because I feel like all the pharmaceutical
powers are looking for a solution that ends up being
profitable, like the patch or the pills," Kroboth said.
"We already know what works. We just need to get
allergists on board and get them familiar with the protocols
and do what we know works."
peanut pill and private practice OIT claim 80 percent to 85
percent success at desensitizing patients to peanut proteins
and cross contamination. Both have strong supporters
suspicious of the other regimen.
you go to the Whole Foods and get peanut flour, you don’t
know the protein content of that peanut flour," Adelman,
the doctor with Aimmune Therapeutics, said. "You either
are administering this as a drug where you know exactly what
you’re giving and you have confidence you’re administering
it in a controlled way, or you can kind of wing it and hope
for the best.
as an allergist dealing with life-threatening allergies, I don’t
play dice with my patients’ lives."
one in 13 children have at least one food allergy, according
to the nonprofit organization Food Allergy Research &
Education, and up to 15 million Americans total. Researchers,
nonprofits and industry members have been scrambling for
solutions for decades.
2001, the National Peanut Board has put over $25.3 million
toward peanut allergy research, including sending funding to
Burks, the lead researcher of the 2009 Duke study. They also
supported a 2015 study that showed that parents should offer
peanut products to very young children at risk of peanut
allergy, in hopes of preventing the allergy.
years, pediatricians had been telling parents to wait until
the child is 2 years old before peanuts are introduced, and
the (2015) study proved that is not the right way to go and
that early introduction is going to be a deterrent to keep
children from developing peanut allergies," said Bob
Sutter of the North Carolina Peanut Growers Association.
North Carolina produced almost 480 million pounds of peanuts.
North and South Carolina are the 5th and 6th growers of
peanuts in the nation.
Kroboth, the peanut-allergic Raleigh child, doses with peanuts
produced and specially processed in N.C., which avoid
cross-contamination with tree nuts and other allergens.
very excited by the possibility that children might be able to
not have to avoid everything," Sutter said.
"Hopefully this (pill) will limit the accidental exposure
from the National Peanut Board and nonprofit organizations
support academic research in labs and with small samples, then
larger pharmaceutical companies step in for large-scale
development and deployment.
FDA approves every product, parents will have several options
if they can find willing allergists: the pill, the patch, the
drops under the tongue and private-practice OIT.
reason you have FDA approval of drugs is because they have
oversight of manufacturing processes — there’s a reason
for regulation," said allergist Dr. Laurie McWilliams,
who does not offer private practice OIT. "That keeps
drugs at the level they should be. What if you get a different
dose on a different day because that peanut doesn’t have the
same high amount of protein content?"
allergist and parent from UNC, said the pill was the most
effective but also the least convenient treatment. The patch
is less effective, but has a short updose period and
a perfect world it would be great to have multiple
treatments," Kim said. "Every child varies. Maybe
the child is higher risk, and even if there’s a little more
difficulty doing the treatment it’s worth it for those.
Maybe for other families it’s all about convenience, and
they need protection but they’re pretty good at avoidance.
love for there to be options. That would give more power to
the allergist and to the families as well."
success of the peanut pill may spread the popularity of
private practice OIT, McWilliams said.
might say the peanut product isn’t different from what’s
in the grocery store, and they’ll go grind it up,"
peanut, Aimmune is working on trials for egg and walnut
allergies. The company behind the peanut patch also is
developing patches for milk and egg allergies.
County public schools do not have nut-free classrooms. Elias
sits at the same lunch table each day for children with
allergies, and teachers wipe him with soap and water before
eating, as opposed to just water like allergy-free children.
Using OIT to increase his tolerance for peanuts has helped the
entire family, Kroboth said.
no doubt in my mind if we had not done OIT it would have been
a traumatic first year of school," Kroboth said. "We
eat out, we fly, we’ve been on vacation, and these are all
things we did not do in the beginning and we now do without
fear. It’s life changing."