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.
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).
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.
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.
ClinicalTrials.gov, NCT00751881; https://clinicaltrials.gov/ct2/show/NCT00751881?term=NCT00751881&rank=1
1Department of Neurology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510000, China
2Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing 100853, China
3Department of Neurology, Beijing Hospital, Beijing 100730, China
4Department of Neurology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
5Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130012, China
6Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China
7Department of Neurology, Shanghai Chang Zheng Hospital, Shanghai 200003, China
8Department of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning 110000, China
9Department of Neurology, Fourth Military Medical University, Xi'an, Shaanxi 710001, China
10Department of Neurology, Peking University First Hospital, Beijing 100034, China
11Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
12Department of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia 014040, China
13Department of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing 100000, China
14Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100050, China
15Department of Neurology, Tianjin Medical University General Hospital, Tianjin 300052, China
16Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China
17Department of Neurology, Hebei General Hospital, Shijiazhuang, Hebei 050051, China
18Department of Neurology, Hua Shan Hospital of the Shanghai Fudan University Medical College, Shanghai 200040, China
19Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
20Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China
21Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215000, China
22Department of Neurology, Beijing Hospital, National Center of Gerontology, Beijing 100083, China
Address for correspondence: Prof. Xian-Hao Xu, Department of Neurology, Beijing Hospital, Beijing 100730, China E-Mail: firstname.lastname@example.org Prof. Xue-Qiang Hu, Department of Neurology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510000, China E-Mail: email@example.com
Wei Qiu, De-Hui Huang, and Shi-Fang Hou contributed equally to this work.
Hai-Feng Li now works at Qilu Hospital of Shandong University, Jinan, Shandong 250012, China.
Some of the data from this analysis were presented previously at the Annual Scientific Meeting of the Australian and New Zealand Association of Neurologists (ANZAN), May 09-12, 2017; Gold Coast, QLD, Australia.
Received August 01, 2018