Copaxone® (glatiramer acetate)
Teva Neuroscience, Inc.
Combination and Comparative Studies:
- Given through daily subcutaneous injections;
dosage is 20 mg.
- Approved for RRMS and CIS.
- Copaxone has been shown to significantly
reduce the annual relapse rate in RRMS and
reduce the risk of people with CIS developing
clinically definite MS (CDMS) at two years.
- Copaxone is a synthetic polypeptide that
mimics myelin basic protein, a key component
of the myelin sheath (the protective covering of
the nerves) that is damaged in MS. This therapy
appears to decrease immune-system T cells that
damage myelin, and may decrease inflammation
by favorably shifting the balance among T-cell
subtypes as well as by affecting several
interleukins. (Interleukins are a type of cytokine,
which are small proteins that may stimulate or
inhibit the function of other cells.) Copaxone
may also induce lymphocytes (immune-system
cells produced to fight infection and disease)
to produce factors that enhance the survival of
cells that produce myelin, and may have a
neuroprotective action that prevents damage
to axons (nerve fibers).
- An international European study was conducted
to determine whether immediate treatment with
Copaxone is better than delayed treatment in
preventing conversion to clinically definite MS
(CDMS). This study has shown that, over five
years, early treatment with Copaxone reduced
the risk of converting to CDMS by 41 percent.
These results establish the importance of
initiating treatment with Copaxone as early as
possible to protect patients from the
accumulation of disease activity.
- Primary-relapsing MS (PRMS) is the least
common form of MS. This has a disease onset
of gradual worsening with subsequent relapses.
There has been some debate as to whether it is
justified to categorize PRMS separately from
primary-progressive MS (PPMS) in terms of
clinical course and prognosis. A sub-analysis of
the PROMISE study of 943 patients with PPMS
(which failed to show that Copaxone was
effective in this group), evaluated differences in
baseline characteristics and disability
progression between patients with PPMS and
PRMS. It showed that some PPMS patients will
ultimately convert to PRMS. Although the
numbers of PRMS patients analyzed in this
study were small, the results suggested that
disease progression is more rapid in this clinical
- The COMBI Rx trial is still ongoing. It is
comparing the combination of Avonex plus
Copaxone to Copaxone alone and Avonex
alone. No data have as yet been reported.
- A Phase II trial to study the effect of combining
Copaxone and estriol (a naturally-occurring
estrogen hormone) in RRMS on relapse rate is
continuing. The study will evaluate relapse rate,
severity of relapses, and changes in the EDSS.
If successful, this clinical trial could lay the
groundwork for a larger, more definitive trial that
might lead to a new oral treatment option for
women with MS. A pilot trial was encouraging.