Kantor Neurology, 4851 W Hillsboro Blvd, Coconut Creek, FL 33073, USA.
Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ 07936, USA.
J Neurol Sci. 2018 May 15;388:168-174. doi: 10.1016/j.jns.2018.03.018. Epub 2018 Mar 10.
To systematically review reports of fingolimod persistence in the treatment of relapsing-remitting multiple sclerosis (RRMS) across data sources and practice settings, and to develop a consensus estimate of the 1-year real-world persistence rate.
A systematic literature review was conducted (MEDLINE, EMBASE, and abstracts from selected conferences [2013-2015]) to identify observational studies reporting 1-year fingolimod persistence among adult patients with RRMS (sample size ≥50). A random-effects meta-analysis was performed to estimate a synthesized 1-year persistence rate and to assess heterogeneity across studies.
Of 527 publications identified, 25 real-world studies reporting 1-year fingolimod persistence rates were included. The studies included patients from different data sources (e.g., administrative claims, electronic medical records, or registries), used different definitions of persistence (e.g., based on prescriptions refills, patient report, or prescription orders), and spanned multiple geographic regions. Reported 1-year persistence rates ranged from 72%-100%, and exhibited statistical evidence of heterogeneity (I = 93% of the variability due to heterogeneity across studies). The consensus estimate of the 1-year persistence rate was 82% (95% confidence interval: 79%-85%).
Across heterogeneous study designs and patient populations found in real-world studies, the consensus 1-year fingolimod persistence rate exceeded 80%, consistent with persistence rates identified in the recently-completed trial, PREFERMS.
系统地回顾在不同数据源和实践环境下使用芬戈莫德治疗复发缓解型多发性硬化症(RRMS)的报告中,芬戈莫德的持续存在情况,并制定一个共识估计的 1 年实际持续率。
进行了系统的文献回顾(MEDLINE、EMBASE 和选定会议的摘要[2013-2015]),以确定报告成人 RRMS 患者 1 年芬戈莫德持续存在率的观察性研究(样本量≥50)。采用随机效应荟萃分析来估计综合的 1 年持续率,并评估研究之间的异质性。
在 527 篇已确定的出版物中,纳入了 25 项报告 1 年芬戈莫德持续存在率的真实世界研究。这些研究包括来自不同数据源(如行政索赔、电子病历或登记处)的患者,使用不同的持续存在定义(如基于处方续药、患者报告或处方医嘱),并跨越多个地理区域。报告的 1 年持续存在率范围从 72%到 100%,并表现出统计学上的异质性证据(I 值为研究之间变异的 93%归因于异质性)。1 年持续存在率的共识估计值为 82%(95%置信区间:79%-85%)。
在真实世界研究中发现的不同研究设计和患者群体中,共识 1 年芬戈莫德持续存在率超过 80%,与最近完成的 PREFERMS 试验中确定的持续存在率一致。