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Title: Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study.
Author: Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH, TOWER Trial Chinese Group.
Journal: Chin Med J (Engl); 2018 Dec 05; 131(23):2776-2784. PubMed ID: 30511679.
Abstract:
BACKGROUND: Disease-modifying therapy is the standard treatment for patients with multiple sclerosis (MS) in remission. The primary objective of the current analysis was to assess the efficacy and safety of two teriflunomide doses (7 mg and 14 mg) in the subgroup of Chinese patients with relapsing MS included in the TOWER study. METHODS: TOWER was a multicenter, multinational, randomized, double-blind, parallel-group (three groups), placebo-controlled study. This subgroup analysis includes 148 Chinese patients randomized to receive either teriflunomide 7 mg (n = 51), teriflunomide 14 mg (n = 43), or placebo (n = 54). RESULTS: Of the 148 patients in the intent-to-treat population, adjusted annualized relapse rates were 0.63 (95% confidence interval [CI]: 0.44, 0.92) in the placebo group, 0.48 (95% CI: 0.33, 0.70) in the teriflunomide 7 mg group, and 0.18 (95% CI: 0.09, 0.36) in the teriflunomide 14 mg group; this corresponded to a significant relative risk reduction in the teriflunomide 14 mg group versus placebo (-71.2%, P = 0.0012). Teriflunomide 14 mg also tended to reduce 12-week confirmed disability worsening by 68.1% compared with placebo (hazard ratio: 0.319, P = 0.1194). There were no differences across all treatment groups in the proportion of patients with treatment-emergent adverse events (TEAEs; 72.2% in the placebo group, 74.5% in the teriflunomide 7 mg group, and 69.8% in the teriflunomide 14 mg group); corresponding proportions for serious adverse events were 11.1%, 3.9%, and 11.6%, respectively. The most frequently reported TEAEs with teriflunomide versus placebo were neutropenia, increased alanine aminotransferase, and hair thinning. CONCLUSIONS: Teriflunomide was as effective and safe in the Chinese subpopulation as it was in the overall population of patients in the TOWER trial. Teriflunomide has the potential to meet unmet medical needs for MS patients in China. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00751881; https://clinicaltrials.gov/ct2/show/NCT00751881?term=NCT00751881&rank=1. 特立氟胺用于中国复发型多发性硬化患者的有效性和安全性：III期TOWER研究亚组分析 摘要 背景：疾病修正治疗是多发性硬化患者缓解期的标准治疗。本研究旨在评估TOWER研究中特立氟胺（7 mg和14 mg）在复发型多发性硬化（RMS）中国患者中的有效性和安全性。 方法：TOWER研究是一项国际多中心、双盲、随机、平行组（3组）、安慰剂对照研究。该亚组分析包括148名中国患者，随机接受特立氟胺7 mg（n=51），特立氟胺14 mg（n=43）或安慰剂（n=54）。 结果： 在148例意向治疗人群中，调整后的ARR分别为安慰剂组0.63（95%可信区间[CI]：0.44, 0.92）、特立氟胺7 mg组0.48（95%CI：0.33，0.70）和特立氟胺14 mg组0.18（95%CI：0.09，0.36）；这相当于特立氟胺14 mg组与安慰剂组相比，相对风险显著降低（-71.2%，P=0.0012），至12周残疾进展风险有下降68.1%的趋势（风险比HR=0.319，P=0.1194），三组患者的治疗相关不良事件（TEAE）的发生率相似，安慰剂组、特立氟胺7 mg组和14 mg组分别为72.2%、74.5%和69.8%，严重TEAE发生率分别为11.1%、3.9%和11.6%。与安慰剂相比，特立氟胺组最常见的TEAE为中性粒细胞减少、丙氨酸氨基转移酶升高和脱发。 结论：TOWER研究中国亚组中特立氟胺的有效性与安全性数据与研究总人群中的结果一致。特立氟胺有潜力满足中国多发性硬化患者的治疗需求。.

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