Zhang Yinan, Gonzalez Caldito Natalia, Shirani Afsaneh, Salter Amber, Cutter Gary, Culpepper William, Wallin Mitchell, Kosa Peter, Bielekova Bibiana, Lublin Fred, Stuve Olaf
Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, USA.
Department of Neurology and Neurotherapeutics, The University of Texas Southwestern Medical Center, Dallas, TX, USA.
Ther Adv Neurol Disord. 2020 Oct 28;13:1756286420969016. doi: 10.1177/1756286420969016. eCollection 2020.
Disease-modifying therapies (DMTs) for multiple sclerosis (MS) are approved for the treatment of disease activity and are effective in reducing relapses and new magnetic resonance imaging (MRI) lesions. However, disease activity generally subsides with time, and age-dependent changes in DMT efficacy are not well-established. We aimed to investigate whether age impacts the efficacy of DMTs in treating disease activity in patients with relapsing-remitting MS (RRMS).
DMT efficacy related to age was assessed through a meta-analysis of clinical trials that evaluated the efficacy of DMTs in RRMS patients as measured by reductions in the annualized relapse rate (ARR), new T2 lesions, and gadolinium-enhanced lesions on MRI. Using the mean baseline patient age from each trial, a weighted linear regression was fitted to determine whether age was associated with treatment efficacy on a group level.
Group-level data from a total of 28,082 patients from 26 trials of 14 different DMTs were included in the meta-analysis. There were no statistically significant associations between age and reductions in ARR, new T2 lesions, and gadolinium-enhanced lesions of the treatment group compared with placebo.
DMTs for RRMS show efficacy in treating disease activity independent of age as demonstrated by group-level data from DMT clinical trials. Nevertheless, clinical trials select for patients with baseline disease activity regardless of age, thereby not representing real-world patients with RRMS, where disease activity declines with age.
用于治疗多发性硬化症（MS）的疾病修正疗法（DMTs）已被批准用于治疗疾病活动，并且在减少复发和新的磁共振成像（MRI）病灶方面有效。然而，疾病活动通常会随着时间消退，且DMT疗效的年龄依赖性变化尚未明确。我们旨在研究年龄是否会影响DMTs治疗复发缓解型多发性硬化症（RRMS）患者疾病活动的疗效。
通过对临床试验进行荟萃分析来评估与年龄相关的DMT疗效，这些试验评估了DMTs对RRMS患者的疗效，具体指标为年化复发率（ARR）降低、新的T2病灶以及MRI上钆增强病灶的减少情况。利用每个试验中患者的平均基线年龄，进行加权线性回归以确定年龄在组水平上是否与治疗疗效相关。
荟萃分析纳入了来自14种不同DMTs的26项试验中总共28,082名患者的组水平数据。与安慰剂相比，治疗组的年龄与ARR降低、新的T2病灶以及钆增强病灶减少之间无统计学显著关联。
DMT临床试验的组水平数据表明，RRMS的DMTs在治疗疾病活动方面显示出与年龄无关的疗效。然而，临床试验入选的是具有基线疾病活动的患者，而不论年龄如何，因此不能代表真实世界中RRMS患者的情况，在真实世界中疾病活动会随年龄下降。
