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Objective  Obtain a more precise estimate of the efficacy of delayed‐release dimethyl fumarate ( DMF ; also known as gastro‐resistant  DMF ) in relapsing multiple sclerosis ( MS ) and examine the consistency of  DMF 's effects across patient subgroups stratified by baseline demographic and disease characteristics.    Methods  A prespecified integrated analysis of the randomized, double‐blind, placebo‐controlled, Phase 3  DEFINE  and  CONFIRM  trials was conducted.    Results  The intent‐to‐treat population comprised 2301 patients randomized to receive placebo ( n  = 771) or  DMF  240 mg twice daily ( BID ;  n  = 769) or three times daily ( TID ;  n  = 761). At 2 years,  DMF BID  and  TID  reduced the annualized relapse rate by 49% and 49% (both  P  < 0.0001), risk of relapse by 43% and 47% (both  P  < 0.0001), risk of 12‐week confirmed disability progression by 32% ( P  = 0.0034) and 30% ( P  = 0.0059), and risk of 24‐week confirmed disability progression by 29% ( P  = 0.0278) and 32% ( P  = 0.0177), respectively, compared with placebo. In a subset of patients ( MRI  cohort),  DMF BID  and  TID  reduced the mean number of new/enlarging T2‐hyperintense lesions by 78% and 73%, gadolinium‐enhancing lesion activity by 83% and 70%, and mean number of new nonenhancing T1‐hypointense lesions by 65% and 64% (all  P  < 0.0001 vs. placebo). Effects were generally consistent across patient subgroups.    Interpretation  The integrated analysis provides a more precise estimate of  DMF 's efficacy.  DMF  demonstrated a robust reduction in disease activity and a consistent therapeutic effect across patient subgroups.

Efficacy of delayed‐release dimethyl fumarate in relapsing‐remitting multiple sclerosis: integrated analysis of the phase 3 trials