학술논문
Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study.
Document Type
Academic Journal
Author
Kallmann BA; Multiple-Sclerosis-Center Bamberg, Bamberg, Germany.; Tiel-Wilck K; Neurologisches Facharztzentrum Berlin, Berlin, Germany, for the NeuroTransData Study Group.; Kullmann JS; Medical Management MS, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Siemensstraße 5b, 63263 Neu-Isenburg, Germany.; Engelmann U; Medical Affairs, Sanofi-Aventis Deutschland GmbH, Neu-Isenburg, Germany.; Chan A; Department of Neurology, Bern University Hospital, University of Bern, Switzerland.
Source
Publisher: SAGE Country of Publication: England NLM ID: 101480242 Publication Model: eCollection Cited Medium: Print ISSN: 1756-2856 (Print) Linking ISSN: 17562856 NLM ISO Abbreviation: Ther Adv Neurol Disord Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
1756-2856
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.
Competing Interests: 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.
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.
Competing Interests: 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.