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Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study

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收录情况: ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 中华系列

机构: [1]Sun Yat Sen Univ, Affiliated Hosp 3, Dept Neurol, Guangzhou 510000, Guangdong, Peoples R China; [2]Chinese Peoples Liberat Army, Gen Hosp, Dept Neurol, Beijing 100853, Peoples R China; [3]Beijing Hosp, Dept Neurol, Beijing 100730, Peoples R China; [4]Shanxi Med Univ, Hosp 1, Dept Neurol, Taiyuan 030001, Shanxi, Peoples R China; [5]Jilin Univ, Hosp 1, Dept Neurol, Changchun 130012, Jilin, Peoples R China; [6]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing 100053, Peoples R China; [7]Shanghai Chang Zheng Hosp, Dept Neurol, Shanghai 200003, Peoples R China; [8]China Med Univ, Hosp 1, Dept Neurol, Shenyang 110000, Liaoning, Peoples R China; [9]Fourth Mil Med Univ, Dept Neurol, Xian 710001, Shaanxi, Peoples R China; [10]Peking Univ, Hosp 1, Dept Neurol, Beijing 100034, Peoples R China; [11]Sichuan Univ, West China Hosp, Dept Neurol, Chengdu 610041, Sichuan, Peoples R China; [12]Baotou Cent Hosp, Dept Neurol, Baotou 014040, Inner Mongolia, Peoples R China; [13]Capital Med Univ, Beijing Friendship Hosp, Dept Neurol, Beijing 100000, Peoples R China; [14]Capital Med Univ, Beijing Tian Tan Hosp, Dept Neurol, Beijing 100050, Peoples R China; [15]Tianjin Med Univ, Gen Hosp, Dept Neurol, Tianjin 300052, Peoples R China; [16]Qingdao Univ, Affiliated Hosp, Dept Neurol, Qingdao 266003, Shandong, Peoples R China; [17]Hebei Gen Hosp, Dept Neurol, Shijiazhuang 050051, Hebei, Peoples R China; [18]Shanghai Fudan Univ, Coll Med, Hua Shan Hosp, Dept Neurol, Shanghai 200040, Peoples R China; [19]Wenzhou Med Univ, Affiliated Hosp 1, Dept Neurol, Wenzhou 325000, Zhejiang, Peoples R China; [20]Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Neurol, Tongji Hosp, Wuhan 430030, Hubei, Peoples R China; [21]Soochow Univ, Affiliated Hosp 1, Dept Neurol, Suzhou 215000, Jiangsu, Peoples R China; [22]Beijing Hosp, Natl Ctr Gerontol, Dept Neurol, Beijing 100083, Peoples R China; [23]Shandong Univ, Qilu Hosp, Jinan 250012, Shandong, Peoples R China
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关键词: Chinese Patients Efficacy Phase 3 Relapsing Multiple Sclerosis Safety Teriflunomide TOWER

摘要:
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.

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出版当年[2017]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
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出版当年[2016]版:
Q3 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2016版] 出版当年五年平均 出版前一年[2015版] 出版后一年[2017版]

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第一作者机构: [1]Sun Yat Sen Univ, Affiliated Hosp 3, Dept Neurol, Guangzhou 510000, Guangdong, Peoples R China;
通讯作者:
通讯机构: [1]Sun Yat Sen Univ, Affiliated Hosp 3, Dept Neurol, Guangzhou 510000, Guangdong, Peoples R China; [3]Beijing Hosp, Dept Neurol, Beijing 100730, Peoples R China;
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