Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, GALA Study Group
To assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3×weekly (tiw) compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
This randomized, double-blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score≤5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety-three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12-month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p<0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p<0.0001) in the cumulative number of gadolinium-enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).
GA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week.
Department of Neurology and Multiple Sclerosis Center, Wayne State University School of Medicine, Detroit, MI 48201, USA. firstname.lastname@example.org