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A Retrospective Study of 116 Multiple Sclerosis Patients with Dimethyl Fumarate Treatment in a Single Institution in
Shoki Sato1,2, Hisashi Uwatoko1,2, Hiroaki Yaguchi1,2
1Department of Neurology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Japan.
Abstract:
Objective The global prevalence of multiple sclerosis (MS) is increasing worldwide. Although many disease-modifying therapies (DMTs) have been approved, they can cause serious adverse events, including infections. Dimethyl fumarate (DMF), an immunomodulator, has a favorable safety profile. In this era of personalized therapy, it is important to select an appropriate DMT for individual patients. This study evaluated DMF treatment outcomes in Japanese patients with MS. Methods The medical records of Japanese patients with MS treated with DMF at a single institution between January 6, 2013, and October 31, 2022, were reviewed retrospectively. The reasons for discontinuation of DMF, switching from other DMTs to DMF, transition of DMF to other medications, absolute lymphocyte count, disease activity assessment, comparison of DMF continuation versus discontinuation, and factors associated with the annualized relapse rate during DMF use were assessed. Results Of the 116 DMF-treated patients, DMF treatment was continued to prevent relapse recurrence in 54.7% of RRMS (n=86) and 23.3% of SPMS (n=30) patients. The main reasons for not continuing DMF treatment included failure to prevent relapse or disease progression (63% of patients who did not continue DMF). A lower annual recurrence rate prior to DMF initiation, lower Expanded Disability Status Scale score, shorter duration from disease onset to DMF initiation, fewer relapse recurrences during DMF therapy, and diagnosis of RRMS were associated with DMF continuation. Conclusion Continuous monitoring is essential after initiating DMF treatment because patients may require transition to other therapies. Overall, 47% of the MS patients were effectively managed with DMF, with favorable outcomes observed in 54.7% of the RRMS patients.
Insights
Dimethyl fumarate (DMF) effectively managed multiple sclerosis (MS) in 47% of Japanese patients, particularly those with relapsing-remitting MS (RRMS). Continuous monitoring is crucial for adjusting treatment as needed.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Global multiple sclerosis (MS) prevalence is rising.
- Disease-modifying therapies (DMTs) for MS carry risks, including infections.
- Dimethyl fumarate (DMF) offers a favorable safety profile as an immunomodulator.
Purpose of the Study:
- To evaluate the treatment outcomes of dimethyl fumarate (DMF) in Japanese patients with multiple sclerosis (MS).
- To identify factors associated with DMF continuation and discontinuation.
- To assess the effectiveness of DMF in managing MS relapses and progression.
Main Methods:
- Retrospective review of medical records for 116 Japanese MS patients treated with DMF (2013-2022).
- Analysis of reasons for DMF discontinuation, treatment transitions, and absolute lymphocyte counts.
- Assessment of disease activity, relapse rates, and factors influencing DMF continuation versus discontinuation.
Main Results:
- DMF treatment was continued for relapse prevention in 54.7% of relapsing-remitting MS (RRMS) and 23.3% of secondary progressive MS (SPMS) patients.
- Primary reasons for discontinuation included failure to prevent relapse or disease progression (63%).
- Factors favoring DMF continuation included lower prior relapse rates, lower EDSS scores, shorter time to treatment initiation, and RRMS diagnosis.
Conclusions:
- Dimethyl fumarate (DMF) effectively managed 47% of MS patients, with higher success rates in RRMS.
- Continuous patient monitoring is essential for timely treatment adjustments.
- Personalized selection of DMTs, including DMF, is critical for optimal MS management.

