Key result
Real-world teriflunomide is linked to a ~67% reduction in MS relapses and improved patient satisfaction.
Why the study?
Limited information was available regarding the real-world use of teriflunomide and changes in its use over time.
Does teriflunomide improve therapy satisfaction and reduce relapses in patients with RRMS in a real-world setting?
Observational (n=752)
Open-label
Yes
Does teriflunomide improve therapy satisfaction and reduce relapses in patients with RRMS in a real-world setting?
In a real-world German cohort, teriflunomide significantly reduced MS relapses and improved patient satisfaction with a safety profile consistent with previous trials.
May support RRMS use; leaves open randomized confirmation before practice change.
Background: Teriflunomide is a once-daily oral disease-modifying therapy (DMT) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Only limited information is available about its real-world use and changes over time. Objectives: To collect real-world data on teriflunomide use in clinical routine (and comparison to the previously conducted study TAURUS-MS). Design: National, open, non-interventional, prospective, multicenter study. Methods: TAURUS-MS II was conducted at 220 German sites between July 2017 and March 2022, including RRMS patients treated with teriflunomide. Data on patient demographics, MS history, previous treatment, therapy satisfaction, and safety were collected. Results: In total, 752 patients were included (65% female) with a mean age (±standard deviation) of 43 ± 11 years. Sixty-six percent had DMT before, and 46% had discontinued their last pretreatment ≤6 months prior to study entry. Among the latter, previous DMTs were interferon (21%), glatiramer acetate (11%), and dimethyl fumarate (9%), and reasons for discontinuation were adverse events (AEs; 55%) and insufficient efficacy (16%). Over 24 months, the mean treatment Satisfaction Questionnaire for Medication scores improved by 6 ± 29 points on effectiveness, 8 ± 20 on convenience, and 12 ± 25 on global satisfaction. The mean number of MS relapses decreased from 0.81 ± 0.81 in the 24 months prior to 0.27 ± 0.57 within 24 months after study entry. Non-serious AEs occurred in 423 patients (56%) and serious AEs in 49 patients (7%). Most reported AEs were alanine aminotransferase increase (11%), hypertension (8%), and alopecia (7%). Compared to TAURUS-MS, patients in TAURUS-MS II were younger, had a higher employment rate, and a higher share of treatment-naïve patients. Conclusion: Mean number of relapses was significantly reduced. Patient satisfaction was significantly improved compared to previous DMT. Tolerability was comparable to previous trials. Trial registration: Bundesinstitut für Arzneimittel und Medizinprodukte public database for non-interventional studies, number 7138.
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Kallmann et al. (2024) conducted an observational in Relapsing-remitting multiple sclerosis (RRMS) (n=752). Teriflunomide was evaluated on Mean number of MS relapses. Real-world use of teriflunomide over 24 months reduced the mean number of MS relapses from 0.81 to 0.27 and improved patient satisfaction.
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