Evidence map›Paper›PMID 38311806›Full record

Trial reportChinese medical journal2025

Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.

Chao Quan, Hongyu Zhou, Huan Yang, Zheng Jiao, Meini Zhang, Baorong Zhang, Guojun Tan, Bitao Bu, Tao Jin, Chunyang Li and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Chinese medical journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04410965 (Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
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.

NCT04410965 phase4completednot on this map

Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks

TypeinterventionalSponsorSanofiRan2020 to 2021Enrolled82ConditionsMultiple SclerosisArmsTERIFLUNOMIDE
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

22 authors at 18 institutions in 1 country.

Chao QuanDepartment of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, National Centre for Neurological Disorders, Shanghai 201206, China.
Hongyu ZhouDepartment of Neurology, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China.
Huan YangDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
Zheng JiaoDepartment of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.
Meini ZhangDepartment of Neurology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030012, China.
Baorong ZhangDepartment of Neurology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Guojun TanDepartment of Neurology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China.
Bitao BuDepartment of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.
Tao JinDepartment of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.
Chunyang LiDepartment of Neurology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia 010050, China.
Qun XueDepartment of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China.
Huiqing DongDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Fudong ShiDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin 300052, China.
Xinyue QinDepartment of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Xinghu ZhangCenter of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Feng GaoDepartment of Neurology, Peking University First Hospital, Beijing100034, China.
Hua ZhangDepartment of Neurology, Beijing Hospital, Beijing 100730, China.
Jiawei WangDepartment of Neurology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730 China.
Xueqiang HuDepartment of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.
Yueting ChenDepartment of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.
Jue LiuMedical Department, Sanofi Investment Co., Ltd., Shanghai 200040, China.
Wei QiuDepartment of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.
Capital Medical University · CNShanghai Jiao Tong University · CNSun Yat-sen University · CNBeijing Hospital · CNFirst Affiliated Hospital of Chongqing Medical University · CNFirst Hospital of Shanxi Medical University · CNFudan University · CNHebei Medical University · CNInner Mongolia Medical University · CNJilin University · CNPeking University · CNSanofi (China) · CNSecond Affiliated Hospital of Zhejiang University · CNSichuan University · CNSoochow University · CNTianjin Medical University General Hospital · CNTongji Hospital · CNXiangya Hospital Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.

methodsThis non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.

resultsEighty-two patients were assigned to variant ( n  = 42) and wild type groups ( n  = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.

conclusionABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients. REGISTRATION: NCT04410965, https://clinicaltrials.gov .

Indexed as

CrotonatesMultiple Sclerosis, Relapsing-RemittingToluidinesAdultATP Binding Cassette Transporter, Subfamily G, Member 2East Asian PeopleFemaleHumansHydroxybutyratesMaleMiddle AgedNeoplasm ProteinsNitrilesProspective StudiesYoung AdultABCG2 protein, humanATP Binding Cassette Transporter, Subfamily G, Member 2CrotonatesHydroxybutyratesNeoplasm ProteinsNitrilesteriflunomideToluidines

Identifiers

PMID38311806
PMCPMC11845184
OpenAlexW4391537876

What OpenQuestion holds

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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.