ECTRIMS 2019 – 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Stockholm, İsveç, 11 - 13 September 2019, cilt.25, no.2, ss.806-889
Background: Efficacy and safety of teriflunomide has been demonstrated in clinical trials, but there is a shortage of data from real-world evidence.
Objective: We aimed to describe efficacy, safety and persistence in patients treated with teriflunomide in real-life clinical settings.
Methods: Using the Imed MS registry, RRMS patients prescribed teriflunomide in 18 MS centers were retrospectively analyzed. Basic demographics, clinical data, relapses, MRI activities, EDSS scores and discontinuations were recorded as part of routine clinical practice.
Results: A total of 1130 RRMS (763 females, 367 males; female/male=2.01) patients treated with teriflunomide were included in the study. Mean age at teriflunomide initiation was 41.3 ± 11.2 years (18-78). Age onset was 30.9 ± 10 (10.4-69.6). Teriflunomide was first line drug in 621 (55%) of the patients. 509 patients switched to teriflunomide from other treatments, 392 (77%) switched from injectable and 49 (9%) from fingolimod, 2 % from natalizumab, 12% from others due to loss of tolerability or inefficacy. The average duration for drug treatment was 16.7 ± 13 months (1 to 80 months). Before treatment, the mean annualized relapse rates (ARR) were 0.63 and the median EDSS was 1.6 (0-5.5). ARR were 0.28 in year 1, 0.24 in year 2, 0.24 in year 3 and 0,20 in year 4. The average time to relapse was 11.2 months. Median EDSS was 1.7 (2.2 ±1.9) in year 1, 2.0 (2.2 ±1.8) in year 2, 2.0 (2.2 ±1.8) and 2.0 (2.6 ±1.9) in year 4. Fifty-three patients had 1 step confirmed EDSS progression. MRI’s showed new or enhanced lesions in 20 % of patients in the first year and % 18 in the second year. 372 patients (%33) discontinued teriflunomide. Discontinuation rates were 13% in year 1 and 24% in year 2. Reported reasons for discontinuations were mainly lack of efficacy, lack of tolerance, adverse events and pregnancy planning. No life-threatened adverse events were encountered.
Conclusion: We found that efficacy and safety of teriflunomide in real-life settings were similar to data obtained by the pivotal trials. In this cohort, the female to male ratio were similar to the MS population treated with other drugs. Relapse rates decreased over 4 years of treatment with teriflunomide compared to pre-treatment. We conclude that teriflunomide is a well-tolerated and effective option especially for early RRMS patients as first-line therapy and switch therapy from other medications in patients without high disease activity.