Time course of clinical and neuroradiological effects of delayed-release dimethyl fumarate in multiple sclerosis.

ABSTRACT:

Background and purpose

Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year, randomized, placebo-controlled, phase 3 DEFINE and CONFIRM trials. A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF.

Methods

Eligible patients were randomized to receive placebo, DMF 240 mg twice (BID) or three times (TID) daily or glatiramer acetate (GA; reference comparator; CONFIRM only) for up to 96 weeks. Patients in the GA group were excluded from this analysis.

Results

A total of 2301 patients were randomized and received treatment with placebo (n = 771) or DMF

SUBMITTER: Kappos L 

PROVIDER: S-EPMC4674988 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature