Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests.
The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE,” was published in the journal Therapeutic Advances in Neurological Disorders.
Tecfidera is approved by the U.S. Food and Drug Administration as an oral treatment for relapsing forms of multiple sclerosis (MS), including RRMS, clinically isolated syndrome (CIS), and active secondary progressive MS (SPMS). It is believed to work by reducing the activity of the immune system.
Data from two Phase 3 studies, DEFINE (NCT00420212) and CONFIRM (NCT00451451), demonstrated the efficacy of Tecfidera, relative to a placebo, in people with RRMS. People who completed these placebo-controlled trials could enroll in an extension study called ENDORSE (NCT00835770), which evaluated Tecfidera’s effectiveness and safety (240 mg capsules twice daily) over years of use.
Researchers here report data from ENDORSE, with a total median follow-up time of nine years (two in the initial trials plus seven in the extension study), with some patients treated for up to 11 years. In total, 1,736 people who completed DEFINE or CONFIRM were enrolled in ENDORSE.
Data showed that Tecfidera treatment effectively prevented relapses in participants. For those given Tecfidera in the initial trials, the annual relapse rate (ARR) ranged from 0.20 relapses/year in the first year to 0.09 relapses/year by eight to nine years of follow-up.
For those initially given placebo — patients who were switched to Tecfidera after enrolling in ENDORSE — initial ARR was 0.35 relapses/year, dropping to less than 0.16 in years three to nine of the ENDORSE study. In this group, “a decreased ARR was apparent as early as year 3–4, and some reduction in ARR continued year-over-year throughout the treatment period,” the researchers wrote.
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