Annualized Relapse Rates Compared Among 3 RRMS Therapies
The full analysis included more than 2600 patients with MS.
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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.