Table 2.
Efficacy outcomes from key registration trials
| TEMSO | TOWER | |||
|---|---|---|---|---|
| Teriflunomide 14 mg (n = 358) | Placebo (n = 363) | Teriflunomide 14 mg (n = 370) | Placebo (n = 388) | |
| Annualized relapse rate | 0.37 | 0.54 | 0.32 | 0.50 |
| Relative reduction vs. placebo (%) | 31.5*** | – | 36.0**** | – |
| Patients remaining relapse free at week 108 (%) | 56.5 | 45.6 | 57.1 | 46.8 |
| Hazard ratio vs. placebo | 0.72** | – | 0.63**** | – |
| Patients with 3-month sustained disability progression at week 108 (%) | 20.2 | 27.3 | 15.8 | 19.7 |
| Hazard ratio vs. placebo | 0.70* | – | 0.68* | – |
| Risk reduction vs. placebo (%) | 30.0 | – | 32.0 | – |
| Patients free of MRI activitya at week 108 (%) | 37.6****b
OR 2.26 (1.61–3.17) |
21.1 | – | – |
| Patients with no evidence of disease activityc at week 108 (%) | 21.2***b
OR 2.06 (1.35–3.13) |
11.6 | – | – |
| Change from baseline in total lesion volume (ml)d at week 108 | 0.72 | 2.21 | – | – |
| Relative reduction vs. placebo (%) | 67.0*** | – | – | – |
| Mean number of T1 Gd-enhancing lesions per scan | 0.38 | 1.18 | – | – |
| Change relative to placebo | −0.80**** | – | – | – |
| Number of unique active lesions per scan | 0.75 | 2.46 | – | – |
| Relative reduction vs. placebo (%) | 69.0**** | – | – | – |
Data in parentheses are 95 % confidence intervals
Gd gadolinium, MRI magnetic resonance imaging, OR odds ratio
* p < 0.05, ** p < 0.01, *** p < 0.001, **** p < 0.0001
aMRI activity was defined as no Gd-enhancing T1 lesions and no new/enlarging T2 lesions. Evaluable patients must have at least one valid MRI scan for assessment over the study duration; Placebo, n = 346; 14 mg, n = 340
bData on file
cNo evidence of disease activity was defined as no Gd-enhancing T1 lesions, no new/enlarging T2 lesions, no confirmed clinical relapse, and no 3-month sustained disability progression. Evaluable patients must have both valid MRI and clinical activity assessments over the study duration; Placebo, n = 346; 14 mg, n = 340
dTotal volume of all abnormal brain tissue and calculated as the sum of the total volume of T2 lesion component and T1 hypointense lesion component