Copaxone® (glatiramer acetate)
- Given through daily subcutaneous injections; dosage is 20 mg.
- Approved for RRMS.
- Copaxone has been shown to significantly reduce the annual relapse rate in RRMS and reduce the risk of 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 that is damaged in MS. It appears to decrease immune system T cells that damage myelin, and may decrease inflammation by shifting the balance among T-cell subtypes as well as by affecting several interleukins. It also may induce lymphocytes to produce factors that enhance the survival of cells that produce myelin, and may have a neuroprotective action that prevents damage to axons.
- Data is now available for 15 years of Copaxone treatment. Only one-third of patients who remain on Copaxone experience disease progression as defined by conversion to SPMS; 57 percent have experienced stable or improved EDSS scores; and 82 percent remain ambulatory without mobility aids. No long-term safety issues have occurred. This study will continue to 20 years.
- The Phase III, 36-month PreCISe study showed that fewer patients with clinically isolated syndrome (CIS) developed CDMS in the treated group than in the placebo group. The conversion of CIS to CDMS was delayed. The time at which 30 percent of patients had converted to CDMS was 569 days in the treated group and 252 in the placebo group. Additionally, the number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower in the treated group.
- An Austrian study indicated that a switch from interferon treatment to Copaxone might be beneficial for individuals who discontinued interferon treatment because of a lack of effectiveness. However, those who switched from an interferon to Copaxone due to side effects showed no substantial change.
- Preliminary evidence suggested that long-term maintenance treatment with Copaxone following immunosuppressive therapy with Novantrone may be effective and well tolerated for individuals with rapidly progressive MS and may stabilize the disease. However, Novantrone use has decreased dramatically in the United States due to adverse effects. (Please see page 18 for more information on Novantrone.)
- A Phase IV study of 60 patients with CIS or early RRMS will assess the effects of Copaxone on the condition of the optic nerve, using the noninvasive technique of optical coherence tomography as an alternative to MRI scanning for follow-up. The study began in September 2009 and is scheduled for completion in June 2012. A parallel Phase III study of 200 individuals with a first episode of optic neuritis will evaluate changes in the retina with Copaxone therapy.
Combination and Comparative studies:
- The COMBI Rx trial is still ongoing, and is comparing the combination of Avonex plus Copaxone to Copaxone alone and Avonex alone. No data have as yet been reported.
- A Phase II study found that Copaxone taken with oral minocycline reduced the number of new and active lesions. The two drugs were also reported to be safe and well tolerated when taken concurrently.
- A Phase II trial to study the effect of combining Copaxone and estriol (a naturally-occurring estrogen hormone) in RRMS on relapse rate began in March 2007 and is scheduled for completion in September 2013. A total of 150 female participants will be enrolled, and the duration of active treatment is two years. 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, definitive trial that might lead to a new oral treatment option for women with MS.
- A study of oral prednisone in 500 relapsing MS patients treated with Copaxone is ongoing. Its primary outcome will be changes in brain volume after three years.