Study 1: A 2-year, randomized, double-blind, placebo-controlled study of 1234 patients with RRMS. The primary endpoint was proportion of patients relapsed.
Study 2: A 2-year, multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm in 1417 patients with RRMS. The primary endpoint was annualized relapse rate.
Relative risk reduction
Placebo: 46%; DMF: 27%
(P<0.0001)
Relative risk reduction
Placebo: 41%; DMF: 29%
(P=0.0020)
Relative
reduction
Placebo: 0.364; DMF: 0.172
(P<0.0001)
Relative
reduction
Placebo: 0.401; DMF: 0.224
(P<0.0001)
Relative risk reduction
Placebo: 27%; DMF: 16%
(P=0.0050)
Relative risk reduction
Placebo: 17%; DMF: 13%
Not statistically significant
(P=0.25)
*Disability progression was defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.