Jan. 20, 2010 -- Two new drugs for multiple sclerosis, both taken orally,
reduce the rates of relapses in multiple sclerosis patients -- sometimes
keeping 80% or more of patients relapse-free during the study period --
according to new research. The new drugs, if approved, promise an end to
injections for some patients.
Results of three studies looking at cladribine and fingolimod for the form
of MS known as relapsing-remitting are published online in the New England
Journal of Medicine. In an accompanying editorial, a doctor suggests the
new drugs could provide a ''new horizon'' for patients and a welcome increase
in treatment options.
"These results are big in that first of all, both these therapies look to be
very effective, appear to be well tolerated, and they have a novel mechanism of
action," says Jeffrey A. Cohen, MD, director of experimental therapeutics at
the Mellen Center for Multiple Sclerosis at the Cleveland Clinic and lead
researcher of one of the studies.
These two new options may be just the beginning, Cohen tells WebMD. "I think
they are harbingers of other medicines on the horizon."
About 400,000 Americans have MS, a chronic, often disabling disease,
according to the National Multiple Sclerosis Society. The body turns on itself,
attacking myelin, the fatty substance protecting nerve fibers in the central
nervous system, leading to damaged nerve fibers and hindering nerve impulses
from traveling to and from the brain and spinal cord. That, in turn, produces
symptoms such as numbness, limb weakness, and blurred vision. About 85% of MS
patients are initially diagnosed with the form of MS known as
relapsing-remitting, in which flare-ups are followed by remissions.
The two new drugs would be the first treatment options that don't involve
injections or infusions.
Cohen's team compared fingolimod in two doses -- 1.25 milligrams or 0.5
milligrams -- with an established treatment for MS, intramuscular injection of
interferon beta-1a (Avonex) at a dose of 30 micrograms per week.
When the researchers looked at the relapse rate after 12 months in 1,153
patients randomly assigned to one of the three treatment groups, they found
that the relapse rate was lower in both groups getting fingolimod.
''The two drugs reduced the relapse rate by 38% to 52%," Cohen tells WebMD.
That translates, he says, to a relapse roughly every five or six years instead
of every three to four.
While 69% of those treated with interferon beta-1a were relapse-free at a
year, nearly 80% of those treated with the higher fingolimod dose were
relapse-free and 82.6% of those treated with the lower dose. Those differences
between fingolimod doses were small, Cohen says.
In another fingolimod study, researchers compared the drug to placebo,
randomly assigning 1,033 patients to either one of two doses of fingolimod (0.5
milligrams or 1.25 milligrams) or to placebo. Patients were followed for 24
Both doses of fingolimod improved the relapse rate. While nearly 75% of
those on the higher fingolimod dose were relapse-free during the study, 70.4%
of those on the lower dose were, but just 45.6% of those on placebo.
They also measured progression of disability, finding that 88.5% of those on
higher doses of fingolimod did not have progression of disability, while 87.5%
of those on the lower dose didn't and 81% of those on placebo did not have