Dimethyl fumarate

(Tecfidera®)

Tecfidera®

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Drug updated on 4/24/2024

Dosage FormCapsule (oral; 120 mg, 240 mg)
Drug ClassNuclear factor (erythroid-derived 2)-like 2 (Nrf2) activators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

Summary
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  • Dimethyl fumarate (Tecfidera) has demonstrated a moderate certainty in reducing relapse rates over 24 months in the treatment of relapsing forms of multiple sclerosis, indicating its effectiveness in reducing the frequency of relapses.
  • A total of 13 systematic reviews and meta-analyses were analyzed to compare Tecfidera's safety and effectiveness against other medications such as natalizumab, cladribine, alemtuzumab, fingolimod, ponesimod, and teriflunomide.
  • Compared to medications like natalizumab, cladribine, and alemtuzumab, high-certainty evidence showed even higher efficacy in reducing MS relapses at 24 months.
  • When directly compared to teriflunomide (TRF), dimethyl fumarate was slightly more effective in reducing the short-term risk but showed no significant difference in confirmed disability worsening.
  • In terms of safety, including adverse effects leading to discontinuation from treatment due to adverse events, it is similar for both dimethyl fumarate (Tecfidera) and other medications such as fingolimod or natalizumab. However, adverse events leading to discontinuation were reported more frequently with dimethyl fumarate than with teriflunomide.
  • Regarding serious adverse events (SAEs), treatments like interferon beta-1a (Avonex), glatiramer acetate, along with dimethyl fumarate, might decrease SAEs when compared against placebo, thus offering a relatively favorable safety profile.
  • For special considerations related to pregnancy outcomes: no significant differences were observed between general population outcomes versus those using different DMTs, including Tecfidera, for premature births, stillbirths, or pregnancy-related MS relapses.
  • Different patient demographics may influence the choice between DMF (Tecfidera) and TRF (Teriflunomide) as younger and treatment-naïve patients might see a lesser difference in efficacy between these two drugs.

Product Monograph / Prescribing Information

Document TitleYearSource
Tecfidera (dimethyl fumarate) Prescribing Information.2022Biogen Idec Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.2024The Cochrane Database of Systematic Reviews
Dimethyl fumarate or teriflunomide for relapsing-remitting multiple sclerosis: a meta-analysis of post-marketing studies.2023Neurotherapeutics
Disease modifying therapy and pregnancy outcomes in multiple sclerosis: A systematic review and meta-analysis.2023Journal of Neuroimmunology
Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.2023The Cochrane Database of Systematic Reviews
Association of disease-modifying therapies with COVID-19 susceptibility and severity in patients with multiple sclerosis: a systematic review and network meta-analysis.2022Multiple Sclerosis International
Post marketing new adverse effects of oral therapies in multiple sclerosis: A systematic review.2022Multiple Sclerosis and Related Disorders
Impact of disease-modifying therapies on MRI outcomes in patients with relapsing -remitting multiple sclerosis: A systematic review and network meta-analysis.2022Multiple Sclerosis and Related Disorders
Disease-modifying therapies and T1 hypointense lesions in patients with multiple sclerosis: A systematic review and meta-analysis.2022CNS Neuroscience & Therapeutics
Disease modifying therapies in relapsing-remitting multiple sclerosis: a systematic review and network meta-analysis.2021Autoimmunity Reviews
Comparative efficacy and safety of ozanimod and dimethyl fumarate for relapsing-remitting multiple sclerosis using matching-adjusted indirect comparison.2021CNS Drugs
Disease-modifying therapies and progressive multifocal leukoencephalopathy in multiple sclerosis: A systematic review and meta-analysis.2021Journal of Neuroimmunology
Safety of dimethyl fumarate for multiple sclerosis: A systematic review and meta-analysis. 2020Multiple Sclerosis and Related Disorders
Comparative efficacy and acceptability of disease-modifying therapies in patients with relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis. 2020Journal of Neurology
Disease modifying therapies in multiple sclerosis: cost-effectiveness systematic review.2020Farmacia Hospitalaria
Benefit-risk of therapies for relapsing-remitting multiple sclerosis: testing the Number Needed to Treat to Benefit (NNTB), Number Needed to Treat to Harm (NNTH) and the likelihood to be helped or harmed (LHH): a systematic review and meta-analysis.2020CNS Drugs