MS Therapy may help delay conversion from
CIS to clinically definite MS
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Medical Update Memo
January 16, 2008
Summary
Copaxone® (glatiramer
acetate) significantly reduced the risk of
developing MS and delayed the
development of MS in individuals with CIS (clinically
isolated syndrome), a first event suggestive of
MS) enrolled in the PreCISe study, according to
a company press release dated December 3, 2007.
Details
Based on these results, the company is stopping
the study early and is giving all participants,
including those who were taking inactive placebo,
an opportunity to receive Copaxone for two years.
The company also reports that it plans to file
requests with regulatory authorities in the U.S.,
Europe and Canada to expand the labeling of Copaxone
to include patients with CIS.
In the PreCISe study, 481 people with CIS with
lesions typical of MS on brain MRIs were randomly
assigned to receive either Copaxone (given by daily
under-the-skin injections) or inactive placebo
for up to 36 months. The primary outcome measure
was the time it took individuals to experience
a second attack that would confirm the diagnosis
of definite MS. An interim analysis of data was
performed as initially planned at the outset of
the trial. According to the press release, the
results showed that, in the Copaxone group, the
risk of developing clinically definite MS was reduced
by 44% versus placebo, and the time to development
of definite MS was delayed by 386 days more than
in the placebo group. The proportion of patients
who developed MS was 43% in the placebo group versus
25% in the Copaxone group.
These data, which have not yet been published in
a peer-reviewed journal, add to growing evidence
for using disease-modifying drugs early to treat
people with CIS who have lesions typical of MS
as detected by brain MRI. Based on similar studies,
Avonex® (interferon beta-1a,) and Betaseron® (interferon
beta-1b,) have already received approval to expand
their labels to treat this indication.
ASK Information System Code: 1.4.1.28.i
Disponible en français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or
therapy, but provides information to assist individuals in making their own
decisions.
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