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

<h4>Objective</h4>Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Scle...

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Autores principales: Viktoria Papp, Mathias Due Buron, Volkert Siersma, Peter Vestergaard Rasmussen, Zsolt Illes, Matthias Kant, Claudia Hilt, Zsolt Mezei, Homayoun Roshanisefat, Tobias Sejbæk, Arkadiusz Weglewski, Janneke van Wingerden, Svend Sparre Geertsen, Stephan Bramow, Finn Sellebjerg, Melinda Magyari
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spelling oai:doaj.org-article:4c38c13ec9ce425b87933408ba9724f92021-12-02T20:11:18ZReal-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.1932-620310.1371/journal.pone.0250820https://doaj.org/article/4c38c13ec9ce425b87933408ba9724f92021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0250820https://doaj.org/toc/1932-6203<h4>Objective</h4>Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013-2019.<h4>Methods</h4>This was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits.<h4>Results</h4>A total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naïve. Compared to previously treated patients, treatment-naïve patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naïve versus previously treated patients experienced a relapse during the follow-up (p<0.0001). Furthermore, 85% of the patients with available data were free of disability worsening at the end of follow-up.<h4>Conclusions</h4>Solid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective and generally well-tolerated DMT for relapsing MS patients with mild to moderate disease activity.Viktoria PappMathias Due BuronVolkert SiersmaPeter Vestergaard RasmussenZsolt IllesMatthias KantClaudia HiltZsolt MezeiHomayoun RoshanisefatTobias SejbækArkadiusz WeglewskiJanneke van WingerdenSvend Sparre GeertsenStephan BramowFinn SellebjergMelinda MagyariPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 5, p e0250820 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Viktoria Papp
Mathias Due Buron
Volkert Siersma
Peter Vestergaard Rasmussen
Zsolt Illes
Matthias Kant
Claudia Hilt
Zsolt Mezei
Homayoun Roshanisefat
Tobias Sejbæk
Arkadiusz Weglewski
Janneke van Wingerden
Svend Sparre Geertsen
Stephan Bramow
Finn Sellebjerg
Melinda Magyari
Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
description <h4>Objective</h4>Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013-2019.<h4>Methods</h4>This was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits.<h4>Results</h4>A total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naïve. Compared to previously treated patients, treatment-naïve patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naïve versus previously treated patients experienced a relapse during the follow-up (p<0.0001). Furthermore, 85% of the patients with available data were free of disability worsening at the end of follow-up.<h4>Conclusions</h4>Solid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective and generally well-tolerated DMT for relapsing MS patients with mild to moderate disease activity.
format article
author Viktoria Papp
Mathias Due Buron
Volkert Siersma
Peter Vestergaard Rasmussen
Zsolt Illes
Matthias Kant
Claudia Hilt
Zsolt Mezei
Homayoun Roshanisefat
Tobias Sejbæk
Arkadiusz Weglewski
Janneke van Wingerden
Svend Sparre Geertsen
Stephan Bramow
Finn Sellebjerg
Melinda Magyari
author_facet Viktoria Papp
Mathias Due Buron
Volkert Siersma
Peter Vestergaard Rasmussen
Zsolt Illes
Matthias Kant
Claudia Hilt
Zsolt Mezei
Homayoun Roshanisefat
Tobias Sejbæk
Arkadiusz Weglewski
Janneke van Wingerden
Svend Sparre Geertsen
Stephan Bramow
Finn Sellebjerg
Melinda Magyari
author_sort Viktoria Papp
title Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
title_short Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
title_full Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
title_fullStr Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
title_full_unstemmed Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.
title_sort real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in the danish multiple sclerosis registry.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/4c38c13ec9ce425b87933408ba9724f9
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