1. Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in the Danish Multiple Sclerosis Registry
- Author
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Zsolt Illes, Stephan Bramow, Volkert Siersma, Tobias Sejbaek, Homayoun Roshanisefat, Mathias Buron, Arkadiusz Weglewski, Viktoria Papp, Melinda Magyari, Zsolt Mezei, Svend Sparre Geertsen, Finn Sellebjerg, Janneke van Wingerden, Peter Vestergaard Rasmussen, Matthias Kant, and Claudia Hilt
- Subjects
Male ,European People ,Epidemiology ,Denmark ,ORAL TERIFLUNOMIDE ,Hydroxybutyrates ,Biochemistry ,Geographical locations ,Diagnostic Radiology ,Cohort Studies ,chemistry.chemical_compound ,DOUBLE-BLIND ,Medical Conditions ,Teriflunomide ,Medicine and Health Sciences ,Ethnicities ,REPORTED OUTCOMES ,Registries ,TREATMENT DECISIONS ,education.field_of_study ,RELAPSING FORMS ,Multidisciplinary ,Radiology and Imaging ,Neurodegenerative Diseases ,Middle Aged ,Magnetic Resonance Imaging ,Europe ,Treatment Outcome ,Neurology ,TOWER ,Research Design ,Crotonates ,Cohort ,DISEASE-MODIFYING THERAPIES ,Medicine ,Female ,TRIAL ,Immunosuppressive Agents ,Research Article ,Cohort study ,Adult ,medicine.medical_specialty ,Multiple Sclerosis ,Toluidines ,Clinical Research Design ,Imaging Techniques ,Science ,Immunology ,Population ,Research and Analysis Methods ,Autoimmune Diseases ,AGE ,Diagnostic Medicine ,Internal medicine ,Nitriles ,medicine ,Humans ,European Union ,Adverse effect ,education ,Danish People ,Expanded Disability Status Scale ,business.industry ,Multiple sclerosis ,Biology and Life Sciences ,Proteins ,medicine.disease ,Demyelinating Disorders ,Discontinuation ,chemistry ,Medical Risk Factors ,Clinical Immunology ,Population Groupings ,Adverse Events ,Interferons ,Clinical Medicine ,People and places ,business - Abstract
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 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.
- Published
- 2021
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