%0 Journal Article
%T Efficacy and safety of dimethyl fumarate in treatment
%A Andr谷 Matta
%A Jang Yun
%A Katsutoshi Hiramatsu
%A Masahiro Mori
%A Masakazu Hase
%A Shinichi Torii
%A Takashi Ohashi
%A Yasuhiro Onizuka
%J Multiple Sclerosis Journal
%@ 2055-2173
%D 2019
%R 10.1177/2055217319852727
%X The use of dimethyl fumarate has not been reported in treatment-naˋve Japanese patients with relapsing每remitting multiple sclerosis. The purpose of this study was to evaluate the efficacy and safety of dimethyl fumarate in treatment-naˋve Japanese patients with relapsing每remitting multiple sclerosis. 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每24 (Part I) and long-term safety (Part II). This post-hoc subgroup analysis evaluated the efficacy and safety of dimethyl fumarate in treatment-naˋve Japanese patients with relapsing每remitting multiple sclerosis (n=52) up to Week 72 (24 weeks Part I and 48 weeks Part II). Dimethyl fumarate reduced the mean total number of new gadolinium-enhancing lesions at Weeks 12每24 by 94% versus placebo; the number of patients who had a relapse over 24 weeks was reduced by 72%. Adverse events leading to discontinuation of the study drug were reported in 9% of patients receiving placebo/dimethyl fumarate and 4% of patients in dimethyl fumarate/dimethyl fumarate. Dimethyl fumarate demonstrated sustained efficacy and acceptable tolerability in treatment-naˋve Japanese patients with relapsing每remitting multiple sclerosis for 72 weeks
%K Dimethyl fumarate
%K multiple sclerosis
%K randomized controlled
%K Japanese
%K treatment-naˋve
%U https://journals.sagepub.com/doi/full/10.1177/2055217319852727