PMID- 30944584
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1756-2856 (Print)
IS  - 1756-2864 (Electronic)
IS  - 1756-2856 (Linking)
VI  - 12
DP  - 2019
TI  - Real-life outcomes of teriflunomide treatment in patients with relapsing multiple 
      sclerosis: TAURUS-MS observational study.
PG  - 1756286419835077
LID - 10.1177/1756286419835077 [doi]
LID - 1756286419835077
AB  - 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(R)) 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 (IFNbeta-1a) in 9.3%, intramuscular IFNbeta-1a 
      or IFNbeta-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.
FAU - Kallmann, Boris A
AU  - Kallmann BA
AD  - Multiple-Sclerosis-Center Bamberg, Bamberg, Germany.
FAU - Tiel-Wilck, Klaus
AU  - Tiel-Wilck K
AD  - Neurologisches Facharztzentrum Berlin, Berlin, Germany, for the NeuroTransData 
      Study Group.
FAU - Kullmann, Jennifer S
AU  - Kullmann JS
AD  - Medical Management MS, Medical Affairs, Sanofi-Aventis Deutschland GmbH, 
      Siemensstrasse 5b, 63263 Neu-Isenburg, Germany.
FAU - Engelmann, Ulrich
AU  - Engelmann U
AD  - Medical Affairs, Sanofi-Aventis Deutschland GmbH, Neu-Isenburg, Germany.
FAU - Chan, Andrew
AU  - Chan A
AD  - Department of Neurology, Bern University Hospital, University of Bern, 
      Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20190327
PL  - England
TA  - Ther Adv Neurol Disord
JT  - Therapeutic advances in neurological disorders
JID - 101480242
PMC - PMC6437319
OTO - NOTNLM
OT  - multiple sclerosis
OT  - observational
OT  - oral
OT  - patient-related outcomes
OT  - treatment
COIS- Conflict of interest statement: BAK has received compensation for activities with 
      Bayer, Biogen, Sanofi Genzyme, Merck, Novartis, Roche, and Teva. KTW has received 
      honoraria for lectures, studies, and consultancy from Almirall, Bayer, Biogen, 
      Genzyme, Ipsen, Merck Serono, Merz Pharma, Novartis, Roche, Sanofi, and Teva. AC 
      has received compensation for activities with Actelion, Almirall, Bayer, Biogen, 
      Celgene, Genzyme, Merck, Novartis, Roche, and Teva for use of university research 
      funds. He receives research support from UCB, and from Sanofi for basic research 
      on drug transport mechanisms relevant to teriflunomide. UE and JK are full-time 
      employees of Sanofi-Aventis Deutschland GmbH.
EDAT- 2019/04/05 06:00
MHDA- 2019/04/05 06:01
PMCR- 2019/03/27
CRDT- 2019/04/05 06:00
PHST- 2018/09/21 00:00 [received]
PHST- 2019/01/08 00:00 [accepted]
PHST- 2019/04/05 06:00 [entrez]
PHST- 2019/04/05 06:00 [pubmed]
PHST- 2019/04/05 06:01 [medline]
PHST- 2019/03/27 00:00 [pmc-release]
AID - 10.1177_1756286419835077 [pii]
AID - 10.1177/1756286419835077 [doi]
PST - epublish
SO  - Ther Adv Neurol Disord. 2019 Mar 27;12:1756286419835077. doi: 
      10.1177/1756286419835077. eCollection 2019.