TY - JOUR

T1 - Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry

AU - Papp, Viktoria

AU - Buron, Mathias Due

AU - Siersma, Volkert

AU - Rasmussen, Peter Vestergaard

AU - Illes, Zsolt

AU - Kant, Matthias

AU - Hilt, Claudia

AU - Mezei, Zsolt

AU - Roshanisefat, Homayoun

AU - Sejbaek, Tobias

AU - Weglewski, Arkadiusz

AU - van Wingerden, Janneke

AU - Geertsen, Svend Sparre

AU - Bramow, Stephan

AU - Sellebjerg, Finn

AU - Magyari, Melinda

PY - 2021

Y1 - 2021

N2 - 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-naive. Compared to previously treated patients, treatment-naive 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-naive versus previously treated patients experienced a relapse during the follow-up (pConclusions 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.

AB - 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-naive. Compared to previously treated patients, treatment-naive 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-naive versus previously treated patients experienced a relapse during the follow-up (pConclusions 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.

KW - DISEASE-MODIFYING THERAPIES

KW - ORAL TERIFLUNOMIDE

KW - RELAPSING FORMS

KW - TREATMENT DECISIONS

KW - REPORTED OUTCOMES

KW - DOUBLE-BLIND

KW - TRIAL

KW - TOWER

KW - AGE

U2 - 10.1371/journal.pone.0250820

DO - 10.1371/journal.pone.0250820

M3 - Journal article

C2 - 34003862

VL - 16

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 5

M1 - 0250820

ER -