Evidence map›Paper›PMID 30511679›Full record

Trial reportChinese medical journal2018

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 and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Chinese medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00751881 (A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis), which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00751881 phase3completednot on this map

A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

TypeinterventionalSponsorSanofiRan2008 to 2015Enrolled1,169ConditionsMultiple SclerosisArmsPlacebo, Teriflunomide
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Observational
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Wei QiuDepartment of Neurology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510000, China.
De-Hui HuangDepartment of Neurology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Shi-Fang HouDepartment of Neurology, Beijing Hospital, Beijing 100730, China.
Mei-Ni ZhangDepartment of Neurology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China.
Tao JinDepartment of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130012, China.
Hui-Qing DongDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Hua PengDepartment of Neurology, Shanghai Chang Zheng Hospital, Shanghai 200003, China.
Chao-Dong ZhangDepartment of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning 110000, China.
Gang ZhaoDepartment of Neurology, Fourth Military Medical University, Xi'an, Shaanxi 710001, China.
Yi-Ning HuangDepartment of Neurology, Peking University First Hospital, Beijing 100034, China.
Dong ZhouDepartment of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
Wei-Ping WuDepartment of Neurology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Bao-Jun WangDepartment of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia 014040, China.
Ji-Mei LiDepartment of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing 100000, China.
Xing-Hu ZhangDepartment of Neurology, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100050, China.
Yan ChengDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin 300052, China.
Hai-Feng LiDepartment of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.
Ling LiDepartment of Neurology, Hebei General Hospital, Shijiazhuang, Hebei 050051, China.
Chuan-Zhen LuDepartment of Neurology, Hua Shan Hospital of the Shanghai Fudan University Medical College, Shanghai 200040, China.
Xu ZhangDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.
Bi-Tao BuDepartment of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.
Wan-Li DongDepartment of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215000, China.
Dong-Sheng FanDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Beijing 100083, China.
Xue-Qiang HuDepartment of Neurology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510000, China.
Xian-Hao XuDepartment of Neurology, Beijing Hospital, Beijing 100730, China.
TOWER Trial Chinese Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisease-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.

methodsTOWER 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).

resultsOf 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.

conclusionsTeriflunomide 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 registrationClinicalTrials.gov, NCT00751881; https://clinicaltrials.gov/ct2/show/NCT00751881?term=NCT00751881&rank=1.

Indexed as

ChinaCrotonatesDouble-Blind MethodDrug Administration ScheduleHumansHydroxybutyratesImmunosuppressive AgentsMulticenter Studies as TopicMultiple SclerosisNitrilesProportional Hazards ModelsToluidinesCrotonatesHydroxybutyratesImmunosuppressive AgentsNitrilesteriflunomideToluidinesChinese PatientsEfficacyPhase 3Relapsing Multiple SclerosisSafetyTeriflunomideTOWER

Identifiers

PMID30511679
PMCPMC6278187

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.