From the Guidelines
Dimethyl fumarate is a recommended treatment option for relapsing-remitting multiple sclerosis (MS) due to its efficacy in reducing relapse rates and slowing disease progression, as supported by recent clinical guidelines and studies 1. When considering the use of dimethyl fumarate for MS, it's essential to weigh the benefits and risks, including the potential for lymphopenia and opportunistic infections.
- Key benefits of dimethyl fumarate include:
- Reduced relapse rates by approximately 50%
- Decreased development of new brain lesions on MRI
- Convenience of oral administration
- Important considerations for dimethyl fumarate treatment:
- Baseline blood tests, including complete blood count, liver function tests, and screening for tuberculosis and hepatitis B
- Regular monitoring of lymphocyte counts to detect potential lymphopenia
- Enhanced pharmacovigilance, including brain MRI every 3–4 months for up to 12 months, when switching from natalizumab to dimethyl fumarate, as recommended by guidelines 1 In clinical practice, dimethyl fumarate is often considered a first-line treatment option for relapsing-remitting MS due to its favorable efficacy and safety profile, as well as the convenience of oral administration.
- Standard dosing regimen:
- 120 mg twice daily for 7 days
- Maintenance dose of 240 mg twice daily
- Common side effects:
- Flushing
- Gastrointestinal symptoms like nausea, diarrhea, and abdominal pain
- Lymphopenia (requiring regular monitoring) Overall, dimethyl fumarate is a valuable treatment option for patients with relapsing-remitting MS, offering a convenient and effective way to manage the disease and slow its progression, as supported by the most recent and highest quality study 1.
From the FDA Drug Label
Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The role of dimethyl fumarate in treating multiple sclerosis (MS) is as a treatment for relapsing forms of the disease, including:
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease in adults 2, 2, 2.
From the Research
Role of Dimethyl Fumarate in Treating Multiple Sclerosis (MS)
Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for the management of relapsing-remitting multiple sclerosis (MS) patients 3, 4. The mode of action of DMF comprises immunomodulatory effects and the activation of nuclear (erythroid-derived 2) related factor-mediated antioxidative response pathways, leading to additional cytoprotective effects 4.
Efficacy of Dimethyl Fumarate
- DMF has been shown to reduce relapse rates by about 50% compared to placebo in phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) 3.
- DMF reduced the number of patients with a relapse and disability worsening over two years, compared to placebo 5.
- The annualised relapse rate was also reduced with DMF treatment 5.
Safety Profile of Dimethyl Fumarate
- The most prevalent side effects of DMF were transient flushing and gastrointestinal tract irritation 4.
- DMF increased the risk for adverse events, including lymphopenia and leukopenia 5.
- Lymphopenia is a common risk factor for progressive multifocal leukoencephalopathy (PML) in DMF-treated patients 6.
- The incidence of PML in DMF-treated patients is rare, with an estimated rate of 1.07 per 100,000 person-years of DMF exposure 6.
Real-World Evidence
- A real-world study found that DMF was effective in reducing disease activity and progression of disability in relapsing MS patients 7.
- The study also found that DMF was well-tolerated, with no serious adverse events reported 7.
- The proportion of patients who developed severe lymphopenia was similar to figures in clinical trials 7.