What have the DEFINE, CONFIRM, and ENDORSE studies shown about the effectiveness of dimethyl fumarate (DMF) in the treatment of relapsing multiple sclerosis (MS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

FDA approval for DMF in adults with relapsing forms of multiple sclerosis [16, 17] was based on data from 2 phase 3 studies, the DEFINE [18] and CONFIRM [19] studies, that involved more than 2600 patients. An ongoing extension study (ENDORSE) includes some patients that have been followed for longer than 4 years.

In the DEFINE trial, dimethyl fumarate significantly reduced [18] : (1) the proportion of patients who relapsed by 49%, (2) the annualized relapse rate by 53%, and (3) the 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38% relative to placebo at 2 years. In the CONFIRM study, dimethyl fumarate significantly reduced the annualized relapse rate by 44% and the proportion of patients who relapsed by 34% compared with placebo at 2 years. [19] Although not statistically significant, dimethyl fumarate also showed a 21% reduction in the CONFIRM trial's 12-week confirmed disability progression. [19] Both studies also showed that dimethyl fumarate significantly reduced lesions in the brain relative to placebo, as measured by magnetic resonance imaging. [18, 19]


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