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

IF 7.5 3区医学 Q1 MEDICINE, GENERAL & INTERNAL Chinese Medical Journal Pub Date : 2025-02-20 Epub Date: 2024-02-05 DOI:10.1097/CM9.0000000000002990

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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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 .

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特立氟胺对中国成年复发性多发性硬化症患者的安全性：一项为期24周的IV期多中心研究。

背景：改变病情疗法已被批准用于治疗复发性多发性硬化症（RMS）。本研究旨在探讨特立氟胺在中国多发性硬化症患者中的安全性：这项非随机、多中心、为期24周的前瞻性研究招募了ABCG2变异型（c.421C>A）或野生型的RMS患者，这些患者每天口服一次特立氟胺14毫克。主要终点是24周内ABCG2多态性与特立氟胺暴露之间的关系。对特立氟胺24周治疗期间的安全性进行了评估：82名患者分别被分配到变异组（n = 42）和野生型组（n = 40）。两组患者在稳态时的给药前浓度（变异型，54.9 [38.0] μg/mL；野生型，49.1 [32.0] μg/mL）和给药间隔血浆浓度-时间曲线下面积（AUCtau）（变异型，1731.3 [769.0] μg∙h/mL；野生型，1564.5 [1053.0] μg∙h/mL）值的几何平均数和几何标准差（SD）大致相似。从治疗突发不良事件（TEAE）、治疗相关 TEAE、≥3 级 TEAE 和严重不良事件（AEs）的发生率来看，变异型组和野生型组的安全性相似且耐受性良好。研究中未报告新的特定安全性问题或死亡病例：ABCG2多态性不影响特立氟胺的稳态暴露，表明变异型和野生型RMS患者具有相似的疗效和安全性：NCT04410965，https://clinicaltrials.gov。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chinese Medical Journal 医学-医学：内科

CiteScore

9.80

自引率

4.90%

发文量

19245

审稿时长

6 months

期刊介绍： The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.