Table 3.
Key clinical efficacy outcomes from the TEMSO and TOWER studies.
| TEMSOa |
TOWERb |
|||
|---|---|---|---|---|
| Teriflunomide 7 mg (n = 365) | Teriflunomide 14 mg (n = 358) | Teriflunomide 7 mg (n = 407) | Teriflunomide 14 mg (n = 370) | |
| RRR for adjusted ARR* versus placebo | 31.2% | 31.5% | 22.3% | 36.3% |
| (p = 0.0002) | (p = 0.0005) | (p = 0.0183) | (p = 0.0001) | |
| HRR for patients with disability progression$ versus placebo | 23.7% | 29.8% | 4.5% | 31.5% |
| (p = 0.0835) | (p = 0.0279) | (p = 0.7620) | (p = 0.0442) | |
Modified intent-to-treat population.
*
Primary efficacy endpoint.
$
Key secondary efficacy endpoint, defined as a persisting increase for at least 12 weeks of ≥ 1.0 point on the EDSS from baseline (or ≥ 0.5 point on the EDSS from baseline if baseline EDSS score > 5.5).
ARR, annualized relapse rate; EDSS, Expanded Disability Status Scale; HRR, hazard risk reduction; RRR, relative risk reduction.
(aAdapted from O’Connor et al. [2011b] Copyright © [2011] Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society; bAdapted from Miller et al. [2013].)