TAURUS-MS II: real-world use of teriflunomide in Germany and changes in treatment patterns over time

Abstract

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.

Keywords: RRMS; multiple sclerosis; patient satisfaction; real-world evidence; teriflunomide; treatment pattern.

Figure 1.

Study flow chart. *Patients could have had multiple reasons for exclusion but only the most important reason is shown. Reasons were weighted as follows: Documentation prior to 1 September 2017 > no signed informed consent > administrative reason > no/early/late teriflunomide therapy > withdrawal of informed consent, data may not be analyzed. An administrative reason was documented for patients who were excluded from the analysis due to unsigned or unhonored doctors’ visits in the eCRF or uncompleted relevant queries. **For one of the patients who died, ‘lack of efficacy’ was documented as the reason for premature study termination instead of ‘death’. ***No premature study termination was documented. eCRFs, electronic case report forms.

Figure 2.

MS relapses. (a) The mean number of MS relapses over time in the total study population and (b) according to patient age. Mean values are indicated above the bars and numbers of patients below the bars, respectively. MS, multiple sclerosis.

Figure 3.

TSQM-9. Mean changes in effectiveness, convenience, and global satisfaction scores from baseline to 24 months in patients who had discontinued their last pretreatment within 6 months prior to study entry, total (a) and according to patient age (b). Paired samples test. Mean values are indicated above the bars and numbers of patients below the bars, respectively. Not significant (ns): p > 0.05. *p ≤ 0.05. **p ≤ 0.01. ***p ≤ 0.001. ****p ≤ 0.0001. TSQM-9, Treatment Satisfaction Questionnaire for Medication