Table 1.
Overview of real-world studies on teriflunomide and Kuwait cohort study.
| Parameters | TOPIC 16 | TESMO 17 | TOWER 18 | Teri-PRO 19 | Kuwait cohort study |
|---|---|---|---|---|---|
| Duration of the study | 108 weeks | 108 weeks | 48 weeks from the last randomized patienta | 48 weeks with dosage according to local labeling | 48 weeks |
| Study population | Total population, N = 618: Placebo (n = 197; females: 135/197 [68.5%]); teriflunomide 7-mg group (n = 205; females: 130/205 [63.4%]); teriflunomide 14-mg group (n = 216; females: 154/216 [71.2%]) | Total population, N = 1088: Placebo (n = 363; females: 275/363 [75.8%]); teriflunomide, 7-mg group (n = 366; females: 255/366 [69.7%]); teriflunomide 14-mg group (n = 359; females: 255/359 [71%]) | Total population, N = 1169: Placebo (n = 389; females: 273/ 389 [70.1%]); teriflunomide 7-mg group (n = 408; females: 300/408 [73.5%]); teriflunomide 14-mg group (n = 372; females: 258/372 [69.3%]) | Total population, N = 1000 (females: 756/1000 [75.6%]): teriflunomide 7-mg group (n = 72); teriflunomide 14-mg group (n = 928) | Patients analyzed: N = 93, and 52 patients were on 1-year follow-up (females: 57/93 [61.2%]) |
| Primary endpoint | Time to relapse confirming clinically definite MS b | ARR | ARR | Global satisfaction (TSQM) at 48 weeks or end of treatment | ARR |
| Key secondary endpoint | Time to relapse or new MRI lesions (gadolinium enhancement or new T2 lesion) | Time to 12-week confirmed disability worsening MRI total lesion volume | Time to 12-week confirmed disability worsening | 1. Change in TSQM in those switching from another DMT in the previous 6 months (baseline to 4 and 48 weeks or end of treatment) 2. Patient-reported disability (MSPS) and QoL (MusiQoL) from baseline to 48 weeks or end of treatment |
The mean change in EDSS at last follow-up and percentage of patients with MRI activity |
| Primary endpoint | ARR: Placebo: 0.284; teriflunomide 14-mg group: 0.194. Risk reduction vs. placebo: 31.9% (teriflunomide 14-mg group) | ARR: Placebo: 0.54, teriflunomide 14-mg group: 0.37 Risk reduction vs. placebo: 31.5% (teriflunomide 14-mg group) | ARR: Placebo: 0.50, teriflunomide 14-mg group: 0.32 Risk reduction vs. placebo: 36.3% (teriflunomide 14-mg group) | The mean TSQM Global Satisfaction score at 48 weeks was high (68.2) | ARR: Patients before teriflunomide treatment: 0.56; patients after teriflunomide treatment: 0.37, p < 0.0001 Risk reductions before and after teriflunomide treatment: Patients after teriflunomide treatment: 92.3%; patients before teriflunomide treatment: 53.8% |
| Adverse events | Placebo: 155/191 [81.1%], and teriflunomide 14-mg group: 183/216 [84.7%] | Placebo: 315/360 [87.5%], and teriflunomide 14-mg group: 325/358 [90.8%] | Placebo: 320/385 [83.1%], and teriflunomide 14-mg group: 320/371 [86.2%] | Teriflunomide group: 823/1000 [82.3%] | Teriflunomide group: 24/52 [46.2%] |
| Any adverse event leading to discontinuation of study medication | Placebo:19/191 [9.9%], and teriflunomide 14-mg group: 18/216 [8.3%] | Placebo: 29/360 [8.1%], and teriflunomide 14-mg group: 39/358 [10.9%] | Placebo: 24/385 [6.2%], and teriflunomide 14-mg group: 58/371 [15.6%] | Teriflunomide 14-mg group: 109/1000 [10.9%] | Teriflunomide 14-mg group: 14/52 [0.2%] |
Fixed end for all patients.
Defined as a new neurological abnormality separated by at least 30 days from the onset of a preceding clinical event, present for at least 24 h, and occurring in the absence of fever or known infection. At least one functional system score or the EDSS score must have increased compared with the previous EDSS assessment, consistent with the patient's symptoms. Screening of patients for entry into the TOPIC study was stopped due to 2010 revisions to the MS diagnostic criteria, which enabled an earlier diagnosis of MS (in some cases at the first clinical event). Patients who were still participating in the study at the stoppage could enter the extension study and receive active treatment with teriflunomide 14 mg or 7 mg.
ARR: Annualized relapse rate; MRI: Magnetic resonance imaging; EDSS: Expanded Disability Status Scale; DMT: Disease-modifying therapy; MRI: Magnetic resonance imaging; MS: Multiple sclerosis; MSPS: Multiple Sclerosis Performance Scale; MusiQoL: Multiple Sclerosis International Quality of Life score; QoL: Quality of life; TSQM: Treatment Satisfaction Questionnaire for Medication; TOPIC: Oral Teriflunomide for Patients with a First Clinical Episode Suggestive of Multiple Sclerosis; TEMSO: Teriflunomide Multiple Sclerosis Oral; TOWER: Teriflunomide Oral in People With Relapsing Multiple Sclerosis; Teri-PRO: Teriflunomide Patient-Reported Outcomes.