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. 2019 Jun 10;5(2):2055217319852727.
doi: 10.1177/2055217319852727. eCollection 2019 Apr-Jun.

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

Masahiro Mori  1 , Takashi Ohashi  2 , Yasuhiro Onizuka, Katsutoshi Hiramatsu, Masakazu Hase  3 , Jang Yun, André Matta  4 , Shinichi Torii  3
Affiliations

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

Masahiro Mori et al. Mult Scler J Exp Transl Clin. .

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 evaluated the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing-remitting multiple sclerosis (n=52) up to Week 72 (24 weeks Part I and 48 weeks Part II).

Results: Dimethyl fumarate reduced the mean total number of new gadolinium-enhancing lesions at Weeks 12-24 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.

Conclusions: Dimethyl fumarate demonstrated sustained efficacy and acceptable tolerability in treatment-naïve Japanese patients with relapsing-remitting multiple sclerosis for 72 weeks.

Keywords: Dimethyl fumarate; Japanese; multiple sclerosis; randomized controlled; treatment-naïve.

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Figures

Figure 1.
Figure 1.
(a) The total number of new gadolinium-enhancing (Gd+) lesions in treatment-naïve Japanese patients with RRMS treated with placebo and dimethyl fumarate 240 mg twice daily at Weeks 12–24. (b) Adjusted ARR for each treatment group. Mean±95% CI.ARR, annualized relapse rate; CI, confidence interval; DMF, dimethyl fumarate.
Figure 2.
Figure 2.
Total number of new gadolinium-enhancing (Gd+) lesions by study visit in treatment-naïve Japanese patients with RRMS treated with placebo and dimethyl fumarate (DMF) 240 mg twice daily.CI: confidence interval.
Figure 3.
Figure 3.
(a) Unadjusted annualized relapse rate (ARR) for Parts I (0–24 weeks) and II (24–72 weeks) of APEX, and (b) the mean total number of Gd+ lesions at Week 24 and 48 for placebo/dimethyl fumarate (DMF) and DMF/DMF treatment groups.
Figure 4.
Figure 4.
(a) Kaplan-Meier estimates of the proportion of patients who relapsed within 72 weeks, and (b) Expanded Disability Status Scale (EDSS) of patients in placebo/dimethyl fumarate (DMF) and DMF/DMF treatment groups over 72 weeks (mean±standard deviation (SD)).
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