Tecfidera significantly reduced relapses and disability progression in newly-diagnosed patients who have highly active MS, as observed in a post-hoc analysis of two years of integrated data from the Phase 3 DEFINE and CONFIRM studies. Patients included in the analysis were diagnosed with relapsing-remitting multiple sclerosis (RRMS) within one year prior to enrolling in the DEFINE or CONFIRM studies, and who were either treatment-naïve or previously treated with corticosteroids alone, and met the criteria for highly active MS (two or more relapses within one year prior to enrolling in DEFINE or CONFIRM). Compared to placebo (n=77) at two years, Tecfidera (n=84) significantly reduced annualized relapse rate (ARR) (56% reduction, P<0.0040), the proportion of patients who relapsed (56% reduction, P=0.0037) and time to sustained 12-week progression of disability (78% reduction, P=0.0067).
Tecfidera provided consistent, long-term efficacy in patients with RRMS who were previously treated with interferon (interferon beta-1a/b [IFN]) or glatiramer acetate (GA), according to an integrated post-hoc analysis in a subset of patients from the Phase 3 DEFINE, CONFIRM and ENDORSE studies. Patients included in the analysis were followed for a minimum of five years (two years in DEFINE/CONFIRM plus three or more years in ENDORSE).
Throughout the study period, the ARR remained low in patients who received continuous treatment with Tecfidera compared to those who initially received two years of placebo in DEFINE/CONFIRM. In patients who switched from placebo in DEFINE/CONFIRM to Tecfidera in ENDORSE, improvements were observed in ARR whether they were treatment-naïve or had treated their MS with IFN or GA.
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