Sanofi Sweden

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Observational Studies Poster Presentation

P0834 - A comparative study of teriflunomide and dimethyl fumarate within the Swedish MS Registry (ID 838)

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Observational Studies



Background: Teriflunomide and dimethyl fumarate first-line have similar labels and are used in similar patients and hence provide a suitable comparison.


The objective of this study was to compare the effectiveness of teriflunomide and dimethyl fumarate (DMF) in a Swedish real-world setting.


All relapsing remitting multiple sclerosis (RRMS) patients in the Swedish MS registry initiating teriflunomide or DMF were included in the analysis. The primary endpoint was treatment persistence. Secondary outcomes included annualised relapse rate (ARR); time to first on-treatment relapse, confirmed disability progression and improvement, and patient reported outcomes. Propensity score matching was used to adjust comparisons for baseline confounders. Marginal Cox models were used to compare time-to-event outcomes by matched treatment groups.


Of the 358 teriflunomide and 1767 DMF patients eligible for the analysis, 353 teriflunomide patients were successfully matched to 353 DMF on a 1:1 basis. There was no difference in the rate of overall treatment discontinuation by treatment group across the entire observation period (HR 1.12; 95% CI 0.91, 1.39; p=0.277; reference=teriflunomide). Within the subset of the patients who discontinued their index treatment, the most frequently reported reason for DMF discontinuation was side effects (89/190; 46.8%) whilst lack of effectiveness was reported in 39/190 (20.5%) of discontinuations. By comparison, lack of effectiveness was cited as the most frequent discontinuation reason in the matched teriflunomide group (72/160; 45%) followed by side effects (63/160; 39.4%). ARR was comparable (p=0.237) between DMF (0.07; 95% CI 0.05-0.10) and teriflunomide (0.09; 95% CI 0.07-0.12). Similarly, there was no difference in time to first on-treatment relapse (HR 0.78; 95% CI 0.50, 1.21; p=0.270; reference=teriflunomide). Furthermore, there was no difference by matched treatment group in the rate of six-month confirmed disability progression (HR 0.55; 95% CI 0.27, 1.12; p=0.100; reference=teriflunomide) or six-month confirmed disability improvement (HR 1.17; 95% CI 0.57, 2.36; p=0.672; reference=teriflunomide). MSIS-29 quality of life scores were also similar over time between the two groups.


This population-based real-world study performed on the Swedish MS registry shows similarities in treatment persistence, clinical effectiveness and quality of life outcomes of teriflunomide and dimethyl fumarate.