Results from the trial also show that patients who remained in the study and were on Copaxone had a relapse rate reduction of more than 80% over a mean of 10 years in the trial. On average, patients experienced only one relapse every five years compared to an average of 1.18 attacks a year before entering the study.
A favorable safety profile was maintained over the course of the study. The most common adverse events associated with Copaxone were local injection-site reactions and immediate post- injection reactions. No other immune-mediated disorders, infections, or malignancies were reported.
This study represents the only prospective, open-label follow-up of more than 10 years’ duration designed to evaluate continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS) patients. The study has now been extended to 15 years.
The results from the trial were published in the June 2006 issue of the journal Multiple Sclerosis.
“Copaxone provides RRMS patients with a treatment option that has demonstrated long-term efficacy and safety,” said Dr Corey Ford, associate professor of Neurology at the University of New Mexico health sciences center and an investigator in the study.