Continued Efficacy and Safety Seen with 15-Year Evaluation of Copaxone

In February 2010, Teva Pharmaceutical Industries Ltd. announced the publication of their data from 15 years of prospective and continuous evaluation of Copaxone®. The 15-year study findings appeared in the February 2010 issue of the journal, Multiple Sclerosis. Given the positive results, this study has been extended to 20 years, and is presently in its 19th year. Copaxone is given via daily subcutaneous injections and is approved for individuals with relapsing-remitting MS (RRMS).

In terms of efficacy, more than 80 percent of individuals with RRMS taking Copaxone for 15 years are still walking without assistance. (This group had a mean average of disease duration of 22 years.) Additionally, two-thirds of these patients have not transitioned to secondary-progressive MS (SPMS), a form of the disease that follows RRMS and is defined by a progressive worsening of symptoms, versus relapses and remissions.

The annual relapse rate was reduced by 78 percent, and more than half of the study participants are reported to have experienced either stable or improved rates of disability. Their rates were measured by the Kurtzke Expanded Disability Status Scale (EDSS). This standardized test gives scores from one to 10 to measure disability, largely in terms of mobility.

In regard to safety, local injection-site reactions and immediate (but transient) post-injection reactions are the most common adverse events with Copaxone. No infections, cancers, or other immune-mediated conditions have been reported.

MSAA Chief Medical Officer Dr. Jack Burks comments, “Once again, long-term Copaxone data has proven it to be very safe, tolerable, and effective in those patients who have remained on therapy for 15 years. The data that 80 percent of Copaxone patients remain able to walk without any aids, after having MS for an average of 22 years, is remarkable. This report should encourage all patients to keep on medications for the long run. This data along with other long-term data, show how much the current medications have helped so many patients.”