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Updated: Jan 21, 2026
Comprehensive Autopsy Program for Individuals with Multiple Sclerosis
Published on: July 19, 2019
Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind
Background:
Current data for the use of dimethyl fumarate (DMF) in Japanese patients with relapsing-remitting multiple sclerosis (RRMS) is limited.
Objectives:
To assess the efficacy of DMF in Japanese patients with RRMS.
Methods:
The phase 3, multinational APEX study (ClinicalTrials.gov identifier: NCT01838668) consisted of two parts: a 24-week double-blind part where subjects were randomized to receive DMF 240 mg or placebo twice daily in East Asian and Eastern European countries, and an open-label extension part where all subjects received DMF. The primary endpoint was the total number of new gadolinium-enhancing lesions in Weeks 12-24. In this interim analysis, we report efficacy data in the Japanese subgroup (DMF n = 56; placebo n = 58) over 72 weeks, including an extension phase.
Results:
DMF reduced the total number of new gadolinium-enhancing lesions in Weeks 12-24 by 85% versus placebo (p < 0.0001). At Week 24, the annualized relapse rate was also reduced by 48% with DMF, versus placebo. DMF reduced the probability of relapse from Week 8 and was sustained. The number of gadolinium-enhancing lesions was maintained through 72 weeks.
Conclusions:
DMF demonstrated sustained efficacy in this Japanese subgroup. The results were consistent with those observed in studies of DMF enrolling primarily Caucasian patients.
Insights
Dimethyl fumarate (DMF) effectively treated Japanese patients with relapsing-remitting multiple sclerosis (RRMS), significantly reducing new lesions and relapses. Efficacy was sustained over 72 weeks, consistent with global study findings.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Limited data exists on dimethyl fumarate (DMF) use in Japanese patients with relapsing-remitting multiple sclerosis (RRMS).
- Assessing DMF efficacy in this specific demographic is crucial for treatment guidelines.
Purpose of the Study:
- To evaluate the efficacy of DMF in Japanese patients diagnosed with RRMS.
- To analyze lesion count and relapse rates over an extended treatment period.
Main Methods:
- Phase 3, multinational APEX study (NCT01838668) involved a 24-week double-blind, placebo-controlled trial with an open-label extension.
- Japanese subgroup (n=114) received DMF or placebo, with efficacy assessed over 72 weeks.
- Primary endpoint: new gadolinium-enhancing lesions (Weeks 12-24).
Main Results:
- DMF reduced new gadolinium-enhancing lesions by 85% versus placebo (Weeks 12-24, p < 0.0001).
- Annualized relapse rate decreased by 48% with DMF at Week 24.
- Sustained reduction in relapse probability and maintained lesion count through 72 weeks.
Conclusions:
- Dimethyl fumarate demonstrated sustained efficacy in Japanese RRMS patients.
- Results align with findings from studies predominantly including Caucasian populations.
- DMF is a viable treatment option for Japanese RRMS patients.
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