Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study

Abstract

Background: Teriflunomide is a once-daily oral immunomodulatory agent approved for the treatment of relapsing–remitting multiple sclerosis (MS). We aimed to obtain data on the effectiveness, tolerability, and subject satisfaction with teriflunomide (Aubagio®) under clinical practice conditions in unselected MS patients. Methods: This work was a non-interventional, prospective, longitudinal, observational study in 307 sites in Germany. Results: A total of 1128 patients were eligible for the efficacy analysis [67.5% female; mean age (± standard deviation) 44.9 ± 9.7 years, range 20–73 years]. Time since first MS symptoms was 10.6 ± 8.2 years, and time since MS diagnosis was 8.9 ± 7.6 years. Expanded Disability Status Scale (EDSS) score at inclusion was 2.3 ± 1.5 (70.4% with score < 3.5). The mean observation period was 16.3 ± 9.1 months. A total of 75.2% had received previous disease-modifying therapies (DMTs) at any time. Of these patients, 504 (44.7%) received no DMT within 6 months of study entry, 593 patients (52.6%) had DMT discontinued prior to study entry [glatiramer acetate in 10.6%, subcutaneous interferon-beta 1a (IFNβ-1a) in 9.3%, intramuscular IFNβ-1a or IFNβ-1b in 6.6% each, azathioprine oral in 0.4%, other in 7.3%, last medication not known in 12.0%]. The mean annualized relapse rate decreased from 0.87 in the 24 months prior to study entry to 0.35 in the 24 months after study entry ( n = 468; p ⩽ 0.001). EDSS and Fatigue Severity Scale remained stable. In patients who received previous MS treatments, Treatment Satisfaction Questionnaire (TSQM-9) values (maximum = 100), for the observation at 24 months improved by 8.1 points for effectiveness, 17.0 points for convenience, and 15.3 points for global satisfaction ( p ⩽ 0.001 each, compared with study entry). In the safety cohort ( n = 1139), the proportion of patients with adverse events (AEs) of any severity was 35.8%, and with serious events 13.0%. The most frequently reported AEs were diarrhea ( n = 55), followed by MS relapse ( n = 48), hair thinning ( n = 38), and viral upper respiratory tract infection ( n = 31). Conclusions: Relapse rate was halved during the observation period in comparison with the same time period before study entry. Patient satisfaction with teriflunomide was high in this real-world observation of patients, the majority of whom switched from other DMTs. The safety and tolerability profile of teriflunomide was similar to that reported in previous clinical trials.

Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry

“…teriflunomide as a first-line choice for at least 95% of eligible RRMS and CIS patients with moderate disease activity, except in women planning pregnancy within a year. Demographic characteristics showed that this real-world cohort had mild to moderate disease activity as indicated by pre-existing relapse activity and EDSS scores, and was older on average than patient cohorts in the phase 3, placebo-controlled TEMSO, TOWER and TOPIC clinical trials, an observation that is consistent with age distributions in other real-world studies with teriflunomide [18,20]. Interestingly, the female population in this cohort had a significantly higher median age than the male population.…”

“…To this end, both the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) endorse the collection of real-world data to answer questions that cannot be addressed in RCTs and/or to provide ongoing benefit-risk analyses of approved DMTs throughout the product lifecycle [15,16]. A growing number of observational studies of teriflunomide are being reported, including studies on patient-reported outcomes [17][18][19][20][21], MRI endpoints [22], compliance and persistence [23], and pregnancy outcomes [24].…”

The association between multiple sclerosis and pain medications

“…Cladribine is a deoxyadenosine analogue which reduces the pro-inflammatory response through depleting lymphocytes 80 . Teriflunomide is another anti-inflammatory medication used in MS, in which the proliferation of rapidly dividing cells, including activated lymphocytes, is inhibited 81 . This inhibition is believed to reduce the extent of the inflammatory response, and thus reduce CNS injury and demyelination in MS patients.…”

Teriflunomide in relapsing-remitting multiple sclerosis: outcomes by age and pre-treatment status

“…The TAURUS-MS I study was one of the first to report experience with teriflunomide under practice conditions in a real-world MS population. 15 Of note, 49.5% of patients were aged 45 years and above, and 24.8% of the observed patients had been treatment-naïve. In this analysis from the TAURUS-MS I study we demonstrate that patients of all age groups and irrespective of pre-treatment status exhibit a decrease of disease activity in terms of relapses under teriflunomide treatment.…”

“…Details of the TAURUS-MS I study (‘Therapie mit Aubagio® unter Praxisbedingungen: Wirksamkeit, Lebensqualität und Verträglichkeit bei Patienten mit schubförmiger Multipler Sklerose’) have been reported previously. 15 In short, this was a non-interventional, prospective, longitudinal study performed by 307 office-based and hospital-based neurologists across Germany from 2014 to 2017. The study was approved locally by the Ethic Committee at the Ruhr-University of Bochum, Faculty of Medicine under number 4874-13, as well as registered in the BfArM public study database under number 2075.…”