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

Wei Qiu; De-hui Huang; Shi-fang Hou; Mei-ni Zhang; Tao Jin; Hui-qing Dong; Hua Peng; Chao-dong Zhang; Gang Zhao; Yi-ning Huang; Dong Zhou; Wei-ping WU; Bao-jun Wang; Ji-mei LI; Xing-hu Zhang; Yan Cheng; Hai-feng LI; Ling LI; Chuan-zhen LU; Xu Zhang; Bi-tao BU; Wan-li Dong; Dong-sheng Fan; Xue-qiang HU; Xian-hao XU; Tower Trial Chinese Group

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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.

Author: Wei QIU ¹ ; De-Hui HUANG ² ; Shi-Fang HOU ³ ; Mei-Ni ZHANG ⁴ ; Tao JIN ⁵ ; Hui-Qing DONG ⁶ ; Hua PENG ⁷ ; Chao-Dong ZHANG ⁸ ; Gang ZHAO ⁹ ; Yi-Ning HUANG ¹⁰ ; Dong ZHOU ¹¹ ; Wei-Ping WU ² ; Bao-Jun WANG ¹² ; Ji-Mei LI ¹³ ; Xing-Hu ZHANG ¹⁴ ; Yan CHENG ¹⁵ ; Hai-Feng LI ¹⁶ ; Ling LI ¹⁷ ; Chuan-Zhen LU ¹⁸ ; Xu ZHANG ¹⁹ ; Bi-Tao BU ²⁰ ; Wan-Li DONG ²¹ ; Dong-Sheng FAN ²² ; Xue-Qiang HU ¹ ; Xian-Hao XU ³ ; TOWER Trial Chinese Group
Author Information

1. Department of Neurology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510000, China.
2. Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
3. Department of Neurology, Beijing Hospital, Beijing 100730, China.
4. Department of Neurology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China.
5. Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130012, China.
6. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
7. Department of Neurology, Shanghai Chang Zheng Hospital, Shanghai 200003, China.
8. Department of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning 110000, China.
9. Department of Neurology, Fourth Military Medical University, Xi'an, Shaanxi 710001, China.
10. Department of Neurology, Peking University First Hospital, Beijing 100034, China.
11. Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
12. Department of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia 014040, China.
13. Department of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing 100000, China.
14. Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100050, China.
15. Department of Neurology, Tianjin Medical University General Hospital, Tianjin 300052, China.
16. Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.
17. Department of Neurology, Hebei General Hospital, Shijiazhuang, Hebei 050051, China.
18. Department of Neurology, Hua Shan Hospital of the Shanghai Fudan University Medical College, Shanghai 200040, China.
19. Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.
20. Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.
21. Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215000, China.
22. Department of Neurology, Beijing Hospital, National Center of Gerontology, Beijing 100083, China.
Collective Name:TOWER Trial Chinese Group
Publication Type:Journal Article
Keywords: Chinese Patients; Efficacy; Phase 3; Relapsing Multiple Sclerosis; Safety; TOWER; Teriflunomide
MeSH: China; Crotonates; administration & dosage; adverse effects; therapeutic use; Double-Blind Method; Drug Administration Schedule; Humans; Immunosuppressive Agents; administration & dosage; adverse effects; therapeutic use; Multicenter Studies as Topic; Multiple Sclerosis; drug therapy; metabolism; Proportional Hazards Models; Toluidines; administration & dosage; adverse effects; therapeutic use
From: Chinese Medical Journal 2018;131(23):2776-2784
CountryChina
Language:English
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.