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; Qun XUE; Huiqing DONG; Fudong SHI; Xinyue QIN; Xinghu ZHANG; Feng GAO; Hua ZHANG; Jiawei WANG; Xueqiang HU; Yueting CHEN; Jue LIU; Wei QIU

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

Author: Chao QUAN ¹ ; Hongyu ZHOU ² ; Huan YANG ³ ; Zheng JIAO ⁴ ; Meini ZHANG ⁵ ; Baorong ZHANG ⁶ ; Guojun TAN ⁷ ; Bitao BU ⁸ ; Tao JIN ⁹ ; Chunyang LI ¹⁰ ; Qun XUE ¹¹ ; Huiqing DONG ¹² ; Fudong SHI ¹³ ; Xinyue QIN ¹⁴ ; Xinghu ZHANG ¹⁵ ; Feng GAO ¹⁶ ; Hua ZHANG ¹⁷ ; Jiawei WANG ¹⁸ ; Xueqiang HU ¹⁹ ; Yueting CHEN ⁴ ; Jue LIU ²⁰ ; Wei QIU ¹⁹
Author Information

1. Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, National Centre for Neurological Disorders, Shanghai 201206, China.
2. Department of Neurology, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China.
3. Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
4. Department of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.
5. Department of Neurology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030012, China.
6. Department of Neurology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
7. Department of Neurology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China.
8. Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.
9. Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.
10. Department of Neurology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia 010050, China.
11. Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China.
12. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
13. Department of Neurology, Tianjin Medical University General Hospital, Tianjin 300052, China.
14. Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
15. Center of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
16. Department of Neurology, Peking University First Hospital, Beijing100034, China.
17. Department of Neurology, Beijing Hospital, Beijing 100730, China.
18. Department of Neurology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730 China.
19. Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.
20. Medical Department, Sanofi Investment Co., Ltd., Shanghai 200040, China.
Publication Type:Clinical Trial, Phase IV
MeSH: Humans; Crotonates/adverse effects*; Toluidines/adverse effects*; Nitriles; Hydroxybutyrates; Female; Male; Adult; ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*; Middle Aged; Multiple Sclerosis, Relapsing-Remitting/genetics*; Prospective Studies; Young Adult; Neoplasm Proteins/genetics*; East Asian People
From: Chinese Medical Journal 2025;138(4):452-458
CountryChina
Language:English
Abstract: 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] 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.
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 .