Key result
Initial dimethyl fumarate linked to a ~54% lower discontinuation rate versus interferons/glatiramer acetate in RRMS.
Why the study?
Population-based real-world evidence studies comparing the effectiveness and tolerability of dimethyl fumarate with common treatment alternatives remain limited.
Does dimethyl fumarate improve clinical effectiveness and tolerability compared to interferons/glatiramer acetate or fingolimod in patients with relapsing-remitting multiple sclerosis?
Cohort (n=2,093)
Yes
Does dimethyl fumarate improve clinical effectiveness and tolerability compared to interferons/glatiramer acetate or fingolimod in patients with relapsing-remitting multiple sclerosis?
Hazard Ratio: 0.46 (95% CI 0.37–0.58)
p-value: p=<0.001
Dimethyl fumarate demonstrates better effectiveness and tolerability than interferons/glatiramer acetate as initial therapy for RRMS, but lower tolerability than fingolimod as secondary therapy.
May favor dimethyl fumarate initially over interferons/glatiramer acetate in RRMS; leaves open randomized comparisons with fingolimod.
Background: Population-based real-world evidence studies of the effectiveness and tolerability of dimethyl fumarate in relation to common treatment alternatives are still limited. Objective: To evaluate the clinical effectiveness and tolerability of dimethyl fumarate (DMF) as the initial and secondary treatment for relapsing-remitting multiple sclerosis (RRMS) patients compared with common treatment alternatives in Sweden. Methods: We conducted a nationwide retrospective observational cohort study of all RRMS patients identified through the Swedish MS registry initiating DMF ( n = 641) or interferons/glatiramer acetate (IFN/GA; n = 555) as the initial therapy, or DMF ( n = 703) or fingolimod (FGL; n = 194) after switch from IFN/GA between 1 January 2014 and 31 December 2016. Results: The discontinuation rate was lower with DMF as the initial treatment than IFN/GA (adjusted hazard rate (HR): 0.46, 95% confidence interval (CI): 0.37–0.58, p < 0.001), but higher than FGL as the secondary treatment (HR: 1.51, CI: 1.08–2.09, p < 0.05). Annualized relapse rate (ARR) was lower with DMF compared to IFN/GA (0.04, CI: 0.03–0.06 vs 0.10, CI: 0.07–0.13; p < 0.05), but not FGL (0.03, CI: 0.02–0.05 vs 0.02, CI: 0.01–0.04; p = 0.41). Finally, time to first relapse (TTFR) was longer with DMF as the initial, but not secondary, therapy ( p < 0.05 and p = 0.20, respectively). Conclusion: Our findings indicate that DMF performs better than IFN/GA as the initial treatment for RRMS. Compared to FGL, DMF displayed a lower tolerability, but largely similar effectiveness outcomes.
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Granqvist et al. (2019) conducted a cohort in Relapsing-remitting multiple sclerosis (RRMS) (n=2,093). Dimethyl fumarate (DMF) vs. Interferons/glatiramer acetate (IFN/GA) or Fingolimod (FGL) was evaluated on Discontinuation rate (initial treatment) (HR 0.46, 95% CI 0.37-0.58, p=<0.001). Dimethyl fumarate as initial treatment for RRMS was associated with a lower discontinuation rate compared to interferons/glatiramer acetate (HR 0.46; 95% CI 0.37-0.58; p<0.001).
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