Long-term treatment with Tecfidera (dimethyl fumarate) continues to be safe and effective at reducing the frequency of relapses and disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), according to 13-year data from a Phase 3 extension study.
The study findings were presented at MSVirtual2020 by Ralf Gold, MD, PhD, professor and chair of the department of neurology at St. Josef-Hospital, Ruhr University Bochum, in Germany, in an oral presentation titled, “Safety and Efficacy in Patients Treated With Dimethyl Fumarate and Followed For 13 Years: Final Results of ENDORSE.” The 8th joint MS meeting was held online Sept. 11-13.
The medication is thought to lower inflammation and oxidative stress — cell damage caused by high levels of oxidant molecules — in the central nervous system (CNS), comprised of the brain and spinal cord. It works by interfering with a signaling pathway involving Nrf2, a protein that controls the activity of genes that regulate oxidative stress.
Data from two previous Phase 3 trials, DEFINE (NCT00420212) and CONFIRM (NCT00451451), had shown that Tecfidera was superior to a placebo at lowering the frequency of relapses and disease progression in people with RRMS. Each trial spanned two years.
Now, Gold presented final 13-year data from the ENDORSE (NCT00835770) trial. That Phase 3 extension study sought to evaluate the long-term safety and efficacy of Tecfidera in RRMS patients who participated in, and completed, either the DEFINE or CONFIRM trials.
During ENDORSE, all patients received Tecfidera at a dose of 240 mg, either two or three times daily.
In addition to the treatment’s safety, the trial investigators evaluated Tecfidera’s effectiveness at lowering the frequency of MS relapses — assessed by the annualized relapse rate (ARR) — and disability progression, based on patients’ scores on the expanded disability status scale (EDSS).
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