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

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<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.

Real-world effectiveness and safety profile of teriflunomide in the management of multiple sclerosis in the Gulf Cooperation Council countries: An expert consensus narrative review

“…22 A complete nationwide population-based cohort study conducted in 3239 patients who were treated with teriflunomide depicted that there was a higher percentage of patients in the treatment-naive group experienced relapse when compared to the patients who had been treated with teriflunomide (p < 0.0001). 23 The adverse events reported (n/N [%]) in the Kuwait cohort were hair thinning (6/52 [11.5%]), diarrhea (5/ 52 [9.6%]), headache (4/52 [7.7%]), increase in alanine transaminase (3/52 [5.8%]), nausea (4/52 [7.7%]), and skin rashes (2/52 [3.8%]) (Table 1). These safety results were comparable to the major clinical trials, namely Teriflunomide Phase II, TEMSO, TOWER, and TOPIC (Table 1).…”

“…22 A complete nationwide population-based cohort study conducted in 3239 patients who were treated with teriflunomide depicted that there was a higher percentage of patients in the treatment-naive group experienced relapse when compared to the patients who had been treated with teriflunomide ( p < 0.0001). 23…”

Favorable benefit–risk ratio with teriflunomide treatment in relapsing-remitting multiple sclerosis: Results of the 2-year, multicenter, prospective, noninterventional TAURUS MS study in Austria

“…However, we think that our results can add relevant knowledge to the current understanding of teriflunomide effectiveness and safety in a real-world setting for several reasons: In contrast to an Italian survey, the TAURUS MS study was designed in a prospective way [ 20 ]. Furthermore, different recent studies did not include patient-related outcomes as an outcome parameter [ 20 , 22 ]. Nevertheless, despite the small sample size, the results support those of the German TAURUS MS I study, which showed a significant decrease in the mean ARR within 24 months of initiation of teriflunomide treatment, plus significantly improved patient satisfaction [ 12 ].…”

“…Also, the TERI-PRO study revealed significant improvements in treatment satisfaction scores following the switch to teriflunomide regardless of the reason for treating with teriflunomide [ 21 ]. Furthermore, real-world outcomes from the Danish Multiple Sclerosis Registry showed a favorable relapse-free and progression-free rate [ 22 ]. Finally, patient-related outcomes in our study showed a similar improvement concerning treatment satisfaction compared with previous surveys [ 12 , 21 ].…”

“…However, outside clinical trials, the available data on the effectiveness of teriflunomide are limited, especially in real-life settings within larger and more diverse populations [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] ]. Therefore, we conducted a prospective, multicenter, open-label, noninterventional study of patients with RRMS who were assigned to treatment with teriflunomide: the TAURUS MS study.…”