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Background and purpose  Delayed‐release dimethyl fumarate ( DMF , also known as gastro‐resistant  DMF ), demonstrated efficacy and safety in relapsing−remitting multiple sclerosis in the 2‐year, randomized, placebo‐controlled, phase 3  DEFINE  and  CONFIRM  trials. A  post hoc  analysis of integrated data from  DEFINE  and  CONFIRM  was conducted to determine the temporal profile of the clinical and neuroradiological effects of  DMF .    Methods  Eligible patients were randomized to receive placebo,  DMF  240 mg twice ( BID ) or three times ( TID ) daily or glatiramer acetate ( GA ; reference comparator;  CONFIRM  only) for up to 96 weeks. Patients in the  GA  group were excluded from this analysis.    Results  A total of 2301 patients were randomized and received treatment with placebo ( n  = 771) or  DMF BID  ( n  = 769) or  TID  ( n  = 761).  DMF  significantly reduced the annualized relapse rate beginning in weeks 0–12 ( BID ,  P  = 0.0159;  TID ,  P  = 0.0314); the proportion of patients relapsed beginning at week 10 ( BID ,  P  = 0.0427) and week 12 ( TID ,  P  = 0.0451); and the proportion of patients with 12‐week confirmed disability progression beginning at week 62 ( BID ,  P  = 0.0454) and week 72 ( TID ,  P  = 0.0399), compared with placebo. These effects were sustained throughout the 2‐year study period.  DMF  significantly reduced the odds of having a higher number of gadolinium‐enhancing lesions by 88% ( BID ) and 75% ( TID ) and the mean number of new or enlarging T2 lesions by 72% ( BID ) and 67% ( TID ), from the first post‐baseline magnetic resonance imaging assessment at 24 weeks (all  P  < 0.0001 versus placebo).    Conclusions  In phase 3 clinical trials,  DMF  demonstrated rapid and sustained clinical and neuroradiological efficacy in relapsing−remitting multiple sclerosis.

Time course of clinical and neuroradiological effects of delayed‐release dimethyl fumarate in multiple sclerosis