Has scientific research made any progress
toward a cure or treatment for celiac disease?
Until about 15 years ago, pharmaceutical
companies showed little interest in drug development for celiac disease, said
Dr. Alessio Fasano, director of the Center for Celiac Research and Treatment at
Massachusetts General Hospital in Boston. At the time, researchers knew that
for those with the condition, consuming gluten — a protein found in wheat, rye
and barley — caused damage to the small intestine. But they didn’t understand
how or why gluten had this effect. And, Fasano said, it seemed there was
already a simple way to manage celiac disease: adopt a gluten-free diet.
اضافة اعلان
For the estimated 1% of people who have this
autoimmune condition, avoiding gluten is the only method for thwarting small
intestine damage and relieving the various symptoms of the disease, which can
include abdominal pain, diarrhea, constipation, depression, fatigue, headache,
a blistery skin rash and iron-deficiency anemia.
But consuming even minuscule amounts of gluten
— just a breadcrumb from a cutting board, for example — can re-trigger symptoms
and intestinal damage. And maintaining a strict gluten-free diet in a world
full of hidden gluten-containing ingredients requires constant vigilance and
makes eating out, traveling and going to school risky and anxiety-provoking,
Fasano said.
In a survey published in 2014, 341 people with
celiac disease rated the burden of managing their condition as worse than those
who had chronic acid reflux or high blood pressure, and similar to those who
lived with diabetes or kidney disease that required dialysis. Despite trying to
avoid gluten, as many as 30% of people with celiac disease still have symptoms,
said Dr. Elena Verdú, a professor of gastroenterology at McMaster University in
Ontario.
Gluten-free foods can also be more expensive
than their gluten-containing counterparts, and many people don’t have access to
the support of a dietitian to help them plan a balanced, gluten-free diet,
Verdú said.
As it’s become clearer that maintaining a
gluten-free diet is neither simple nor satisfactory for many celiac patients,
researchers have also made recent strides in grasping how the disease works. We
now understand “almost step-by-step the march, the progress from the moment in
which you break down gluten to the point in which you destroy your intestine,”
Fasano said. “An entire world opens up in terms of new treatments.”
There are 24 potential therapies at various
stages of development, according to the Celiac Disease Foundation. Those being
tested target different steps in the disease pathway, Fasano said. Some are
enzymes meant to improve the digestion of gluten, breaking it down into
smaller, less harmful fragments. Other approaches make the lining of the small
intestine less porous, so that it’s more difficult for partly digested gluten
to enter the body. Still others target the immune system to prevent it from
damaging the intestine in response to gluten, Fasano said.
If proved safe and effective, these potential
therapies probably would not be cures for celiac disease, but they could
mitigate the effects of accidentally eating small amounts, Verdú said.
Still, they’re most likely at least a few
years away from being approved. “Drug design and approval is a really very
lengthy path,” said Verdú, whose clinic is participating in several trials but
who does not have any financial ties to the drugs.
Of the potential therapies in development, the
one furthest along — now being tested in a Phase 3 trial — is a drug called
larazotide, which decreases the porosity of the small intestine. In a best-case
scenario, larazotide could be approved and on the market within two to three
years, said Fasano, who was involved with the development of the drug and has a
financial interest in it.
But, he added, for every five or six drugs
tested in Phase 3 trials, only one or two will be approved. Several other
potential therapies are now in Phase 2 trials; which could be five to six years
from market, Fasano said.
The cost of celiac therapies would vary. The larazotide
and digestive enzyme treatments are relatively cheap — they “cost cents to
produce,” Fasano said — but drugs targeting the immune or inflammatory response
would be more expensive.
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