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- Title
Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials.
- Authors
Viglietta, Vissia; Miller, David; Bar‐Or, Amit; Phillips, J. Theodore; Arnold, Douglas L.; Selmaj, Krzysztof; Kita, Mariko; Hutchinson, Michael; Yang, Minhua; Zhang, Ray; Dawson, Katherine T.; Sheikh, Sarah I.; Fox, Robert J.; Gold, Ralf
- Abstract
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.
- Subjects
MULTIPLE sclerosis research; MULTIPLE sclerosis treatment; BISOPROLOL; DISEASE relapse; PLACEBOS; DRUG efficacy; THERAPEUTICS
- Publication
Annals of Clinical & Translational Neurology, 2015, Vol 2, Issue 2, p103
- ISSN
2328-9503
- Publication type
Article
- DOI
10.1002/acn3.148