Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial.

ABSTRACT:

Objective

To assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods

Patients completing FTY720 Research Evaluating Effects of Daily Oral Therapy in MS (FREEDOMS) were eligible for this dose-blinded, parallel-group extension study, continuing fingolimod 0.5 mg/day or 1.25 mg/day, or switching from placebo to either dose, randomized 1:1. Efficacy variables included annualized relapse rate (ARR), brain volume loss (BVL), and confirmed disability progression (CDP). Between-group analyses were conducted in the intent-to-treat (ITT) population from FREEDOMS baseline to end of study. Within-group analyses compared years 0-2 (FREEDOMS) and years 2-4 (extension) in the extension ITT population.

Results

Of 1,27

SUBMITTER: Kappos L 

PROVIDER: S-EPMC4408283 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature