![[ Visit Client Website ]](images/banner.gif)
Objectives: To assess the efficacy and safety of 40-mg GA administered t.i.w. in patients with relapsing-remitting multiple sclerosis (RRMS).
Methods: RRMS patients (N = 1404) were randomized in a 2:1 ratio to receive GA (n = 943) 40mg t.i.w. s.c. injection or matched placebo (n = 461) for 12 months. Neurological examinations occurred at screening, baseline, 1, 3, 6, 9, and 12 months or early discontinuation. MRI scans were obtained at baseline and months 6 and 12. Study endpoints included annualized relapse rate (ARR) and MRI markers of disease pathology.
Results: Compared with placebo, treatment with GA 40mg t.i.w. led to a 34.4% reduction (P < .001) in annualized relapse rate (ARR). At 12 months, the cumulative number of new or enlarging T2 lesions (34.7% reduction, P < .001) and gadolinium-enhancing (GdE) lesions (44.8% reduction, P < .001) were significantly lower in GA patients. Post-hoc assessments indicated that a greater proportion of patients receiving GA were disease free (no relapses, GdE or T2 lesions, or progression on Expanded Disability Status Scale [EDSS] at months 6 or 12) relative to placebo (GA 23.3%, placebo 15.2%, P < .001). A greater proportion of patients in the GA 40mg t.i.w. group were also free of MRI disease activity (no GdE or T2 lesions at months 6 and 12; GA 29.8%, placebo 21.5%, P = .001) and clinical disease activity (no relapses, no EDSS progression; GA 74.7%, placebo 63.9%, P < .001).
Conclusions: Glatiramer acetate at 40mg t.i.w. significantly reduced the ARR as well as the cumulative number of new/enlarging T2 and GdE lesions. It also significantly increased the proportion of patients free of disease markers. At a dose of 40 mg t.i.w., GA may provide an alternative therapeutic option of a higher dose of GA at a reduced injection frequency.