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 -