Drug updated on 4/24/2024
| Dosage Form | Capsule (oral; 120 mg, 240 mg) |
| Drug Class | Nuclear 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
- 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 Title | Year | Source |
|---|---|---|
| Tecfidera (dimethyl fumarate) Prescribing Information. | 2022 | Biogen Idec Inc., Cambridge, MA |