Biogen Idec presented new data demonstrating the favorable efficacy, safety, and tolerability of Tecfidera (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis (RRMS). The data reinforces Tecfidera efficacy in RRMS patients with high disease activity, as well as showing that gastrointestinal (GI) events were primarily mild and manageable. These results were presented at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia.
Post-hoc analysis of pooled data from the global, two-year, double-blind, placebo-controlled, dose-comparison Phase 3 studies DEFINE and CONFIRM produced findings consistent with the results from the overall intent-to-treat populations in each trial individually. In patients experiencing ≥2 relapses yearly (highly active disease), twice-daily Tecfidera significantly reduced annualized relapse rates by 60% (P=0.0018) and the proportion of patients who relapsed by 63% (P=0.0030); no significant effect in 12-week confirmed disability progression was observed.
The open-label, single-arm Phase 4 MANAGE trial evaluated the incidence and prevalence of GI adverse events in US patients receiving Tecfidera for relapsing forms of MS. Data from this study showed GI events were mostly mild or moderate in severity and occurred transiently, primarily during the first month of treatment. Less than 10% of patients reported GI events by the 10th week of treatment; discontinuation due to these side effects was only 7.3%.
Tecfidera is an oral Nrf2 pathway activator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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