Department of Neurology, Xiangya Hospital, Central South University, Changsha, China.
The First Affiliated Hospital, Hunan University of Chinese Medicine, Changsha, China.
Mult Scler Relat Disord. 2022 Feb;58:103446. doi: 10.1016/j.msard.2021.103446. Epub 2021 Dec 12.
Since September 2012, when teriflunomide was approved as a disease-modifying treatment for relapsing multiple sclerosis, real-world observational studies on teriflunomide in Chinese patients are limited.
We collected demographic characteristics and peripheral blood samples at different time points. Clinical symptoms, magnetic resonance imaging data, and concentrations of neurofilament light chains and multiple cytokines at different time points were compared to assess the efficacy. Moreover, the safety was assessed by blood routine, liver and kidney function, and a questionnaire to report adverse reactions.
Teriflunomide significantly reduced serum levels of neurofilament light chains and several inflammatory cytokines. After accepting teriflunomide treatment, many clinical symptoms improved, scores of the expanded disability status scale decreased from 2.0 to 1.75, and annualized relapse rates decreased from 1.45 to 0.31. 29 (80.56%) and 15 (78.95%) patients achieved the no evidence of disease activity-3 status after 6 months and 12 months treatment, respectively. Teriflunomide was associated with mild or moderate discomfort, and discontinuation rates due to adverse events were low.
Serum neurofilament light chain protein is sensitive to teriflunomide treatment, suggesting that it has the potential to be used as an indicator to assess the efficacy of teriflunomide. Teriflunomide can significantly reduce the concentrations of inflammatory cytokines, indicating that teriflunomide may regulate neuroinflammation through the inhibitory effect on a variety of immune cells and their cytokines. Teriflunomide can improve clinical symptoms and disease severity in MS patients in southern China, and patients have good compliance.
自 2012 年 9 月特立氟胺被批准用于治疗复发型多发性硬化症以来，在中国患者中开展的特立氟胺真实世界观察性研究较为有限。
我们收集了不同时间点的人口统计学特征和外周血样本。比较了不同时间点的临床症状、磁共振成像数据以及神经丝轻链和多种细胞因子的浓度，以评估疗效。此外，通过血常规、肝肾功能和报告不良反应的问卷来评估安全性。
特立氟胺可显著降低血清神经丝轻链和几种炎症细胞因子的水平。接受特立氟胺治疗后，许多临床症状得到改善，扩展残疾状况量表评分从 2.0 降至 1.75，年复发率从 1.45 降至 0.31。29（80.56%）和 15（78.95%）例患者在治疗 6 个月和 12 个月后分别达到无活动疾病状态-3。特立氟胺与轻度或中度不适相关，因不良反应停药率较低。
血清神经丝轻链蛋白对特立氟胺治疗敏感，提示其可能作为评估特立氟胺疗效的指标。特立氟胺可显著降低炎症细胞因子的浓度，表明特立氟胺可能通过抑制多种免疫细胞及其细胞因子来调节神经炎症。特立氟胺可改善中国南方 MS 患者的临床症状和疾病严重程度，且患者具有良好的依从性。
