Department of Clinical Medicine, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China.
Department of Clinical Medicine, The Affiliated Jiangyin Hospital, School of Medicine, Southeast University, No. 3 yingrui road, Jiangyin, 214400, Jiangsu Province, China.
Neurol Sci. 2022 Jun;43(6):3565-3581. doi: 10.1007/s10072-022-05988-y. Epub 2022 Mar 3.
As one kind of disease-modifying therapies, sphingosine-1-phosphate receptor (S1PR) modulators such as fingolimod, ozanimod, and siponimod have been approved or are being developed to treat multiple sclerosis (MS). Several randomized controlled trials (RCT) have been implemented to compare the efficacy and safety of S1PR modulators versus interferon beta in the treatment of people with relapsing-remitting multiple sclerosis (RRMS).
We searched RCTs which were implemented from January 2010 to June 2020 by searching PubMed, Embase, Cochrane Library databases, and the Central Register of Controlled Trials. Finally, five RCTs were included in our study after carefully choosing.
We pooled 4304 patients from 5 RCTs. The primary outcome was the annualized relapse rate. We found that the annualized relapse rate in the S1PR modulator group is 20% less than that in the interferon beta group (95%CI, - 0.32 to - 0.07, P = 0.002). S1PR modulators led to a significant reduction in number of new or enlarging T2 lesions per scan and number of gadolinium-enhancing lesions compared with interferon beta. Moreover, S1PR modulators can also improve 54-item multiple sclerosis quality of life (MSQOL-54) physical health composite score (P = 0.0005).
S1PR modulators exhibited good efficacy and safety for the treatment of RRMS compared with interferon beta. According to follow-up trials, S1PR modulators can improve MSQOL-54 physical health composite score so that it may be beneficial to neurological recovery which need more research to confirm.
作为一类疾病修正疗法,鞘氨醇-1-磷酸受体(S1PR)调节剂,如芬戈莫德、奥扎尼莫德和西尼莫德,已被批准或正在开发用于治疗多发性硬化症(MS)。已经实施了几项随机对照试验(RCT),以比较 S1PR 调节剂与干扰素β在治疗复发缓解型多发性硬化症(RRMS)患者中的疗效和安全性。
我们通过检索 PubMed、Embase、Cochrane 图书馆数据库和中央对照试验注册库,检索了 2010 年 1 月至 2020 年 6 月实施的 RCT。经过仔细选择,最终有 5 项 RCT 纳入我们的研究。
我们从 5 项 RCT 中纳入了 4304 名患者。主要结局是年化复发率。我们发现 S1PR 调节剂组的年化复发率比干扰素β组低 20%(95%CI,-0.32 至-0.07,P=0.002)。与干扰素β相比,S1PR 调节剂可显著减少每扫描的新或扩大的 T2 病变数量和钆增强病变数量。此外,S1PR 调节剂还可以改善 54 项多发性硬化症生活质量(MSQOL-54)的生理健康综合评分(P=0.0005)。
与干扰素β相比,S1PR 调节剂在治疗 RRMS 方面显示出良好的疗效和安全性。根据后续试验,S1PR 调节剂可以提高 MSQOL-54 生理健康综合评分,因此可能对神经恢复有益,但需要更多的研究来证实。