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[Dimethyl Fumarate in Multiple Sclerosis].

Masami Tanaka1, Yuko Shimizu

  • 1MS Center, Kyoto Min-Iren Chuo Hospital.

Brain and Nerve = Shinkei Kenkyu No Shinpo
|September 14, 2017
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Summary
This summary is machine-generated.

Dimethyl fumarate (DMF) is a new multiple sclerosis drug showing benefits but also adverse effects like flushing and lymphopenia. Further research is needed to optimize DMF dosing for Japanese patients to minimize risks.

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Area of Science:

  • Neuroimmunology
  • Pharmacology
  • Clinical Therapeutics

Background:

  • Dimethyl fumarate (DMF) is the sixth disease-modifying drug approved for multiple sclerosis (MS) in Japan.
  • Phase III trials (DEFINE, CONFIRM) demonstrated DMF's efficacy in Western RRMS patients, showing reduced relapse rates and disease activity.
  • The APEX study in Japanese RRMS patients confirmed efficacy but highlighted adverse events.

Purpose of the Study:

  • To evaluate the efficacy and safety of dimethyl fumarate (DMF) in Japanese patients with relapsing-remitting multiple sclerosis (RRMS).
  • To identify adverse effects associated with DMF treatment in the Japanese MS population.
  • To inform optimal dosing strategies for DMF in Japan.

Main Methods:

  • Analysis of data from randomized, placebo-controlled, phase III studies (DEFINE, CONFIRM, APEX).
  • Assessment of clinical outcomes including annual relapse rate and confirmed disease progression.
  • Monitoring of adverse events, including gastrointestinal issues, flushing, and lymphopenia.

Main Results:

  • DMF demonstrated beneficial effects in Japanese RRMS patients, similar to Western populations.
  • Common adverse effects included flushing and gastrointestinal events, leading to treatment discontinuation.
  • Serious adverse events like progressive multifocal leukoencephalopathy (PML) and grade 3 lymphopenia were observed, particularly in older patients.

Conclusions:

  • Dimethyl fumarate (DMF) is effective for Japanese patients with relapsing-remitting multiple sclerosis (RRMS).
  • Adverse effects, including lymphopenia and gastrointestinal symptoms, require careful monitoring and management.
  • Further studies are necessary to establish optimal DMF dosage and escalation protocols for the Japanese population to mitigate risks.