Tecfidera® (dimethyl fumarate)
FDA-Approved Medications: New Data
- Starting dose: 120 mg twice a day, orally for seven days; ongoing dose: 240 mg twice a day, orally
- Approved in 2013 for RMS
The exact mechanism by which Tecfidera, or dimethyl fumarate, exerts its therapeutic effects in MS is not known. The medication has been shown to activate a pathway involved in the cellular response to oxidative stress, which is induced by inflammation. However, it is unclear whether this pathway activation plays a role in the impact Tecfidera has on the MS disease process.12
The FDA approved Tecfidera for use in RRMS in 2013. That approval followed completion of two randomized, double-blind, placebo-controlled trials showing that the medication reduced the annualized relapse rate by 44 percent to 53 percent relative to placebo. These trials also showed that Tecfidera had a favorable impact on disability progression and MRI measures of MS activity, compared to placebo.12
In 2017, the prescribing information for Tecfidera was amended to direct physicians to obtain a complete blood-cell count and to measure liver enzymes and other values before initiating the drug. Additionally, warnings were added to the prescribing information, noting that progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, and liver injury have occurred in people taking Tecfidera.12
Recent research into Tecfidera has focused on its relative effectiveness compared with other disease-modifying therapies (DMTs) and on how comorbidities – other health conditions – affect the use and effectiveness of this medication in people with RRMS. The results of that research were presented in October 2017.
Italian investigators drew on a database of more than 3,000 people newly diagnosed with RRMS between 2010 and 2016 to compare how these individuals responded to initial treatment with Tecfidera, Aubagio® (teriflunomide), interferon beta-1a, or glatiramer acetate. The first two medications are oral therapies; the second two are injectables. The researchers used a method called propensity score, which matches people treated with different medications by their age, sex, and other factors, thus allowing comparisons.
Employing this process, they found that patients receiving Tecfidera had a significantly lower risk of relapse compared to individuals receiving interferon beta-1a. They found no significant difference in time to first relapse among people taking Aubagio relative to those receiving interferon beta-1a or glatiramer acetate. Similarly, they did not identify a difference in time to relapse between interferon beta-1a and glatiramer acetate, but noted that in some cases, larger numbers of matched patients would be needed to assess differences.13