• Chinese medical journal · Feb 2024

    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, and Wei Qiu.
    • Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, National Centre for Neurological Disorders, Shanghai 201206, China.
    • Chin. Med. J. 2024 Feb 5.

    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 (AUCtau) (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.RegistrationNCT04410965, https://clinicaltrials.gov.Copyright © 2024 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

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