Miller Aaron E, Xu Xianhao, Macdonell Richard, Vucic Steve, Truffinet Philippe, Benamor Myriam, Thangavelu Karthinathan, Freedman Mark S
Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Department of Neurology, Beijing Hospital, Beijing, China.
J Clin Neurosci. 2019 Jan;59:229-231. doi: 10.1016/j.jocn.2018.09.012. Epub 2018 Oct 20.
In the phase 3 TOWER (NCT00751881) study, teriflunomide 14 mg significantly reduced annualized relapse rate (ARR) and risk of 12-week confirmed disability worsening (12-w CDW) vs placebo in patients with relapsing forms of MS (RMS). The TOWER population included an appreciable proportion of Asian patients. Reductions in ARR and 12-w CDW associated with teriflunomide 14 mg were comparable between the Asian and overall populations, as were the rates for adverse events and serious adverse events, with no new or unexpected safety findings. These observations provide further evidence to support the clinical benefits and safety profile of teriflunomide in a broad range of patients with RMS.
在3期TOWER（NCT00751881）研究中，与安慰剂相比，14毫克特立氟胺显著降低了复发型多发性硬化症（RMS）患者的年化复发率（ARR）和12周确认残疾恶化风险（12-w CDW）。TOWER研究人群中包含相当比例的亚洲患者。14毫克特立氟胺所致的ARR和12-w CDW降低在亚洲人群和总体人群中相当，不良事件和严重不良事件发生率也是如此，未发现新的或意外的安全性结果。这些观察结果为支持特立氟胺在广泛的RMS患者中的临床益处和安全性提供了进一步证据。
