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Background and purpose  Significant effects on clinical/neuroradiological disease activity have been reported in patients with relapsing–remitting multiple sclerosis treated with delayed‐release dimethyl fumarate ( DMF ) in phase  III DEFINE / CONFIRM  trials. We conducted a  post hoc  analysis of integrated data from  DEFINE / CONFIRM  to evaluate the effect of  DMF  on achieving no evidence of disease activity ( NEDA ) in patients with relapsing–remitting multiple sclerosis.    Methods  The analysis included patients randomized to  DMF  240 mg twice daily, placebo or glatiramer acetate ( CONFIRM  only) for ≤2 years. A time‐to‐event method was used to estimate the percentage of patients achieving  NEDA . Clinical  NEDA  (no relapses/no 12‐week confirmed disability progression) was analysed in the intention‐to‐treat ( ITT ) population. Neuroradiological (no new/newly enlarging T2 hyperintense lesions/no gadolinium‐enhancing lesions) and overall NEDA (clinical and neuroradiological  NEDA ) were analysed in the magnetic resonance imaging ( MRI ) cohort.    Results   The ITT  and  MRI  populations comprised 1540 and 692 patients, respectively. The percentage of patients with clinical  NEDA  ( ITT  population) and neuroradiological  NEDA  ( MRI  cohort) was higher with  DMF  versus placebo over 2 years [clinical NEDA: 38.9% relative reduction; hazard ratio (HR), 0.61; 95% confidence interval (CI), 0.52‐0.72;  P  < 0.0001; neuroradiological  NEDA : 40.0% relative reduction;  HR , 0.60; 95%  CI , 0.49–0.73;  P  < 0.0001]. The percentage of patients achieving overall  NEDA  ( MRI  cohort) was also higher with  DMF  (26%) versus placebo (12%) over 2 years, with a relative risk reduction of 42.7% ( HR , 0.57; 95%  CI , 0.48–0.69;  P  < 0.0001).    Conclusions  A significantly higher percentage of patients treated with  DMF  achieved  NEDA  status over 2 years compared with placebo.

european journal of neurology

Effect of delayed‐release dimethyl fumarate on no evidence of disease activity in relapsing–remitting multiple sclerosis: integrated analysis of the phase  III DEFINE  and  CONFIRM  studies