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Delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) is one of the newest oral therapeutics. In the phase 3 DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS)1 and CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis)2 trials, DMF 240 mg twice daily and three times daily demonstrated efficacy on clinical and neuroradiologic measures across diverse subgroups of patients.3,4 The most common adverse events associated with DMF treatment were flushing and gastrointestinal (GI) events, including abdominal pain, nausea, vomiting, and diarrhea. Other safety signals of note included decreases in mean white blood cell and lymphocyte counts and transient elevations in mean liver enzyme levels. There was no overall increased risk of infections, serious infections, opportunistic infections, or malignancies in DMF-treated patients.
|Materials and Methods|
DEFINE and CONFIRM were 2-year, multicenter, randomized, double-blind, placebo-controlled clinical trials. In DEFINE, patients were randomized 1:1:1 to receive placebo, DMF 240 mg twice daily, or DMF 240 mg three times daily (408, 410, and 416 patients, respectively, in the safety population, defined as patients who received at least one dose of study treatment) for up to 96 weeks. In CONFIRM, patients were randomized 1:1:1:1 to receive treatment with placebo, DMF 240 mg twice or three times daily, or glatiramer acetate (a reference comparator; safety population = 363, 359, 344, and 351 patients, respectively) for up to 96 weeks.
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