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

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  • Viktoria Papp
  • Mathias Due Buron, Københavns Universitet
  • ,
  • Volkert Siersma, Københavns Universitet
  • ,
  • Peter Vestergaard Rasmussen
  • Zsolt Illes, Syddansk Universitet
  • ,
  • Matthias Kant, Hospital of Southern Jutland
  • ,
  • Claudia Hilt, Aalborg Universitet
  • ,
  • Zsolt Mezei, Aalborg Universitet
  • ,
  • Homayoun Roshanisefat, Syddansk Universitet
  • ,
  • Tobias Sejbæk, Hospital of Southwestern Jutland
  • ,
  • Arkadiusz Weglewski, Københavns Universitet
  • ,
  • Janneke Van Wingerden, Sanofi Genzyme
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  • Svend Sparre Geertsen, SANOFI
  • ,
  • Stephan Bramow, Københavns Universitet
  • ,
  • Finn Sellebjerg, Københavns Universitet
  • ,
  • Melinda Magyari, Københavns Universitet

Objective 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. Methods 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. Results 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. Conclusions 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.

TidsskriftPLOS ONE
StatusUdgivet - maj 2021

Bibliografisk note

Publisher Copyright:
© 2021 Papp et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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