WEDNESDAY, March 14 (HealthDay News) — Yet another orally taken
medication shows some promise in preventing relapse and disability for
people with relapsing-remitting multiple sclerosis, a new report
suggests.
In the new study, laquinimod reduced the annual relapse rate by 23
percent, and disability progression by 36 percent.
“We found that laquinimod, as compared with placebo, reduced the rate
of relapse and slowed the progression of disability in patients with
relapsing-remitting multiple sclerosis,” the European researchers, led by
Dr. Giancarlo Comi of the Institute of Experimental Neurology in Milan,
wrote.
The study, which was funded by the drug’s manufacturer, Teva
Pharmaceutical Industries, was published in the March 15 issue of the
New England Journal of Medicine.
Multiple sclerosis (MS) is a disease that damages the outside of nerve
fibers in the central nervous system, according to the National Multiple
Sclerosis Society. The brain, spine and optic nerves make up the central
nervous system. Symptoms of the disease can include fatigue, numbness in
the limbs, balance and coordination problems, bladder or bowel
dysfunction, vision problems, pain and even paralysis, according to the
society.
Most patients — about 85 percent — have a form of MS that’s called
relapsing-remitting, the society has reported. That means that people have
periods where the disease is very active, and at other times the disease
remits. During these periods of remission, there may be complete or
partial recovery of function, and the disease doesn’t progress during
remission, according to the society.
All of the more than 1,100 people included in the current study had
relapsing-remitting MS; the volunteers came from 139 sites in 24
countries. They were randomly assigned to receive a laquinimod pill or an
inactive placebo once daily for 24 months.
The annual relapse rate for those on the active drug was 0.30 compared
to 0.39 for those on a placebo, a reduction in relapse of 23 percent for
those on the medication. During the study, 63 percent of those on the drug
remained relapse-free compared to 52 percent of those on placebo.
Just over 11 percent of those taking laquinimod had confirmed
disability progression compared to 15.7 percent of those on placebo, the
researchers found.
The drug was generally well-tolerated. The most significant side
effects appeared to be urinary tract infections and a temporary
abnormality in liver function tests.
This isn’t the first pill developed for MS. The first was Gilenya,
which was approved in 2010 for the treatment of relapsing-remitting MS.
This drug is currently under increased scrutiny in the United States and
Europe because there have been 11 unexpected deaths in people taking the
drug. Several other oral medications are in development. One is called
teriflunomide, and it’s also for the treatment of relapsing-remitting MS;
its manufacturer recently filed for approval in the United States and
Europe. Before Gilenya was approved, MS medications had to be given by
injection.
“This is meaningful because it’s a more convenient way of taking
medication. I don’t think it will differ significantly in efficacy from
other agents. The safety data looks good now, but many low-frequency side
effects only become apparent [after a drug has been approved] in
post-marketing trials,” said Dr. Malcolm Gottesman, chief of the division
of neurology, co-director of neuroscience and director of the Winthrop
Comprehensive MS Care Center at Winthrop University Hospital in Mineola,
N.Y.
“Right now, it looks good. It looks like it works and is easy to take,”
Gottesman said, adding that it’s not going to be a groundbreaking change
in treatment.
Timothy Coetzee, chief research officer for the MS society, said
laquinimod works differently than the other pills and looks as if it might
have some protective effects that other drugs don’t offer, though more
research is needed into that potential aspect.
He said it’s not clear if laquinimod’s modest effect on relapse rates
is “clinically meaningful,” which means, does it make a difference to
someone living with MS? He said that if the manufacturer files for U.S.
Food and Drug Administration approval, “regulators are looking for a
clinically meaningful impact.”
But, Coetzee added, “This study illustrates that there are oral agents
becoming available for people with MS. And, it brings hope that we will
have a next generation of agents, and that we can hopefully stop the
progression of MS.”
More information
Learn more about multiple sclerosis from the National Multiple Sclerosis Society.
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