PMID- 38311806
OWN - NLM
STAT- Publisher
LR  - 20240205
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Linking)
DP  - 2024 Feb 5
TI  - Safety of teriflunomide in Chinese adult patients with relapsing multiple 
      sclerosis: A phase IV, 24-week multicenter study.
LID - 10.1097/CM9.0000000000002990 [doi]
AB  - BACKGROUND: Disease-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. METHODS: This 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. RESULTS: Eighty-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] 
      mug/mL; wild type, 49.1 [32.0] mug/mL) and area under plasma concentration-time 
      curve over a dosing interval (AUCtau) (variant, 1731.3 [769.0] mug∙h/mL; wild 
      type, 1564.5 [1053.0] mug∙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. 
      CONCLUSION: ABCG2 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.
CI  - Copyright (c) 2024 The Chinese Medical Association, produced by Wolters Kluwer, 
      Inc. under the CC-BY-NC-ND license.
FAU - Quan, Chao
AU  - Quan C
AD  - Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan 
      University, National Centre for Neurological Disorders, Shanghai 201206, China.
FAU - Zhou, Hongyu
AU  - Zhou H
AD  - Department of Neurology, West China Hospital of Sichuan University, Chengdu, 
      Sichuan 610041, China.
FAU - Yang, Huan
AU  - Yang H
AD  - Department of Neurology, Xiangya Hospital, Central South University, Changsha, 
      Hunan 410008, China.
FAU - Jiao, Zheng
AU  - Jiao Z
AD  - Department of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai 
      Jiao Tong University, Shanghai 200025, China.
FAU - Zhang, Meini
AU  - Zhang M
AD  - Department of Neurology, The First Hospital of Shanxi Medical University, 
      Taiyuan, Shanxi 030012, China.
FAU - Zhang, Baorong
AU  - Zhang B
AD  - Department of Neurology, The Second Affiliated Hospital Zhejiang University 
      School of Medicine, Hangzhou, Zhejiang 310009, China.
FAU - Tan, Guojun
AU  - Tan G
AD  - Department of Neurology, The Second Hospital of Hebei Medical University, 
      Shijiazhuang, Hebei 050000, China.
FAU - Bu, Bitao
AU  - Bu B
AD  - Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei 430030, China.
FAU - Jin, Tao
AU  - Jin T
AD  - Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin 
      130021, China.
FAU - Li, Chunyang
AU  - Li C
AD  - Department of Neurology, The Affiliated Hospital of Inner Mongolia Medical 
      University, Hohhot, Inner Mongolia 010050, China.
FAU - Xue, Qun
AU  - Xue Q
AD  - Department of Neurology, The First Affiliated Hospital of Soochow University, 
      Suzhou, Jiangsu 215006, China.
FAU - Dong, Huiqing
AU  - Dong H
AD  - Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 
      100053, China.
FAU - Shi, Fudong
AU  - Shi F
AD  - Department of Neurology, Tianjin Medical University General Hospital, Tianjin 
      300052, China.
FAU - Qin, Xinyue
AU  - Qin X
AD  - Department of Neurology, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing 400016, China.
FAU - Zhang, Xinghu
AU  - Zhang X
AD  - Center of Neurology, Beijing Tiantan Hospital, Capital Medical University, 
      Beijing 100070, China.
FAU - Gao, Feng
AU  - Gao F
AD  - Department of Neurology, Peking University First Hospital, Beijing100034, China.
FAU - Zhang, Hua
AU  - Zhang H
AD  - Department of Neurology, Beijing Hospital, Beijing 100730, China.
FAU - Wang, Jiawei
AU  - Wang J
AD  - Department of Neurology, Beijing Tongren Hospital, Capital Medical University, 
      Beijing, 100730 China.
FAU - Hu, Xueqiang
AU  - Hu X
AD  - Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, 
      Guangzhou, Guangdong 510630, China.
FAU - Chen, Yueting
AU  - Chen Y
AD  - Department of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai 
      Jiao Tong University, Shanghai 200025, China.
FAU - Liu, Jue
AU  - Liu J
AD  - Medical Department, Sanofi Investment Co., Ltd., Shanghai 200040, China.
FAU - Qiu, Wei
AU  - Qiu W
AD  - Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, 
      Guangzhou, Guangdong 510630, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04410965
PT  - Journal Article
DEP - 20240205
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
SB  - IM
EDAT- 2024/02/05 06:43
MHDA- 2024/02/05 06:43
CRDT- 2024/02/05 00:02
PHST- 2023/05/14 00:00 [received]
PHST- 2024/02/05 06:43 [medline]
PHST- 2024/02/05 06:43 [pubmed]
PHST- 2024/02/05 00:02 [entrez]
AID - 00029330-990000000-00949 [pii]
AID - 10.1097/CM9.0000000000002990 [doi]
PST - aheadofprint
SO  - Chin Med J (Engl). 2024 Feb 5. doi: 10.1097/CM9.0000000000002990.