Efficacy and safety of dimethyl fumarate in treatment-naive Japanese patients with multiple sclerosis: Interim analysis of the randomized placebo-controlled study.

ABSTRACT:

Background

The use of dimethyl fumarate has not been reported in treatment-naïve Japanese patients with relapsing-remitting multiple sclerosis.

Objectives

The purpose of this study was to evaluate the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing-remitting multiple sclerosis.

Methods

APEX was a phase 3, multinational trial, which consisted of a 24-week, randomized (1:1), double-blind study where patients received dimethyl fumarate 240 mg or placebo twice daily, followed by an open-label extension where all patients received dimethyl fumarate 240 mg. The primary endpoints were the total number of new gadolinium-enhancing (Gd+) lesions in Weeks 12-24 (Part I) and long-term safety (Part II). This post-hoc subgroup analysis e

SUBMITTER: Mori M 

PROVIDER: S-EPMC6558550 | biostudies-literature | 2019 Apr-Jun

REPOSITORIES: biostudies-literature