Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years

In a randomized placebo-controlled double-blind study, glatiramer acetate ( Copaxone(R)) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in on open-label study with all patients receiving active drug . The majority of the original double-blind cohort continues to receive gla tiramer acetate by daily subcutaneous injection and ore evaluated at 6-mont h intervals and during suspected relapse. The data reported here ore from a pproximately 6 years of organized evaluation, including the double-blind ph ase of up to 35 months and the open-label phase of over 36 months. Daily su bcutaneous injections of 20 mg glatiramer acetate were well tolerated The m ean annual relapse rate of the patients who received glatiramer acetate sin ce randomization and continued into the open-label study was 0.42 (95% conf idence interval (CI), CI=0.34-0.51). The rate per year has continued to dro p and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologicall y unchanged or have improved from baseline by at least one step on the Expe nded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded providing informati on about their current status and reasons for dropping out This study demon strates the sustained efficacy of glatiramer acetate in reducing the relaps e rate and in slowing the accumulation of disability in patients with relap sing forms of multiple sclerosis.