Dimethyl fumarate for multiple sclerosis.

Area of Science:

• Neuroscience
• Immunology
• Pharmacology

Background:

• Multiple sclerosis (MS) significantly impairs neurological function and quality of life.
• Dimethyl fumarate (DMF) is an approved first-line therapy for relapsing-remitting MS (RRMS) due to its immunomodulatory and neuroprotective properties.

Purpose of the Study:

• To evaluate the efficacy and safety of dimethyl fumarate (DMF) in RRMS patients.
• To compare DMF monotherapy or combination therapy against placebo or other disease-modifying drugs.

Main Methods:

• Systematic review of randomized controlled trials (RCTs) comparing DMF (monotherapy or combination) with placebo or active comparators for MS.
• Included trials had a follow-up of at least one year.
• Data extraction and quality assessment were performed independently by two reviewers.

Main Results:

• Two RCTs involving 2667 RRMS patients compared DMF (240 mg twice or thrice daily) with placebo over two years.
• DMF significantly reduced relapses and disability worsening compared to placebo (moderate to low quality evidence).
• Common adverse events included flushing and gastrointestinal issues; uncommon but significant events were lymphopenia and leukopenia.

Conclusions:

• Dimethyl fumarate demonstrates efficacy in reducing relapses and, to a lesser extent, disability worsening in RRMS patients compared to placebo.
• The safety profile includes common mild-to-moderate events and uncommon but significant hematological changes (lymphopenia, leukopenia).
• High-quality, long-term studies are needed to fully assess DMF's impact on disability progression and long-term safety.