May 10, 2006

Data from a 10-year study showed that 92 percent of relapsing-remitting multiple sclerosis (RRMS) patients who remained on Teva's Copaxone (glatiramer acetate injection) were still walking without assistance despite an average disease duration of more than 15 years. The study was published in the journal Multiple Sclerosis.

The study, which was conducted in 251 RRMS patients, began in 1991 as a double-blind, placebo-controlled trial in which patients were randomized to receive either 20 mg of Copaxone or placebo by subcutaneous injection daily for a mean of 30 months. A total of 232 patients (125 on Copaxone and 107 placebo, the modified intent-to-treat cohort) were evaluated.

Investigators looked at the percentage of patients who progressed to Kurtzke Expanded Disability Status Scale (EDSS) 4, at which they were still ambulatory despite moderately severe disability; to EDSS 6, at which a cane, crutch or brace is required for mobility; and to EDSS 8, in which patients were wheelchair-bound. At the start of treatment, patients had an average EDSS score of 2.79. After 10 years, the patient group on Copaxone showed significantly decreased accumulation of disability, with 24 percent of patients reaching EDSS 4, eight percent reaching EDSS 6 and one percent reaching EDSS 8.

"Copaxone provides RRMS patients with a treatment option that has demonstrated long-term efficacy and safety," said Corey Ford, director of the Multiple Sclerosis Specialty Clinic at the University of New Mexico Health Sciences Center and a lead investigator in the trial. "Results of the study are consistent with the presumed mechanism of action of Copaxone, which appear to treat inflammation and neurodegeneration, the underlying pathologies of multiple sclerosis These data [are] clinically useful for the MS community."