|The following article is part of live conference coverage from the 2018 ACTRIMS Forum in San Diego, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from ACTRIMS 2018.|
Real-world data from a multicenter study indicated no significant difference in the proportion of patients with multiple sclerosis (MS) who relapsed after taking dimethyl fumarate and fingolimod, but a statistically significantly higher proportion of relapse-free patients was seen for those treated with dimethyl fumarate vs glatiramer acetate, according to researchers at ACTRIMS Forum 2018, in San Diego, California.
For patients with relapsing-remitting MS (RRMS), delayed-release dimethyl fumarate, fingolimod, and glatiramer acetate are commonly prescribed as treatment. With a lack of direct comparator studies, researchers aimed to provide real-world evidence comparing dimethyl fumarate with fingolimod and glatiramer acetate in patients with RRMS.
The EFFECT study (ClinicalTrials.gov identifier: NCT02776072) was an international, retrospective, single-time-point medical record review study that compared the efficacy of dimethyl fumarate (N=816) vs other disease-modifying therapies such as fingolimod (N=781) and glatiramer acetate (N=1042). Study endpoints were the Kaplan-Meier-estimated proportion of patients relapsed at month 12 as well as the annualized relapse rate. Estimates of relapse and treatment effects were pooled across 4 strata balanced in baseline covariates.
The analysis showed an estimated 12% of dimethyl fumarate-treated patients who relapsed at 12 months vs 13% of fingolimod-treated patients (hazard ratio, 1.07; 95% CI, 0.78-1.46; P =.6926). The adjusted annualized relapse rate ratio was 1.09 (95% CI, 0.80-1.49; P =.5754).
When compared with glatiramer acetate, the estimated proportion of dimethyl fumarate-treated patients who relapsed at 12 months was 12% vs 21% of glatiramer acetate-treated patients (hazard ratio, 0.71; 95% CI, 0.54-0.95), a significant 29% reduction (P =.0195). The adjusted annualized relapse rate ratio was 0.66 (95% CI, 0.50-0.87), marking a significant 34% reduction (P =.0033).
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Min J, Sloane J, Phillips JT, et al. Leveraging real-world evidence for comparative effectiveness: delayed-release dimethyl fumarate vs. fingolimod and glatiramer acetate in RRMS. ACTRIMS Forum 2018; February 1-3, 2018; San Diego, CA. Abstract P016.