Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Mult Scler Relat Disord. 2019 May;30:252-256. doi: 10.1016/j.msard.2019.02.028. Epub 2019 Mar 1.
The risk benefit ratio of continuing immunomodulating disease modifying therapy (DMT) in older MS patients is unknown. To date, only retrospective observational studies on DMT discontinuation have been published. In these studies, DMT discontinuation was based solely on disease stability and patients frequently had to restart treatment. Our prior study demonstrated that discontinuing DMT can be more successful when age is also considered. The impact of discontinuing DMT on patients' quality of life has not been previously explored. The objective of this study is to determine changes in outcomes over time between those who continued versus discontinued DMT using patient-reported outcomes (European Quality of Life 5 Dimensions (EQ-5D) index, Performance Scales (PS), and Patient Health Questionnaire (PHQ9)) and walking speed (Timed 25-foot walk) in MS patients over age 60.
We conducted a retrospective, observational study in which we identified patients from our MS clinics who were 60 years of age or older and had been on DMT ≥2 years. We compared outcome evolution over time among treatment groups (continuers, discontinuers before discontinuation (DBD), and discontinuers after discontinuation (DAD)), by creating separate mixed-effects linear regression models that included an interaction term between time from age 60 and treatment group to study outcome trajectories. Independent variables were time from age 60 and treatment group, with the following covariates: age at diagnosis, gender, disease course at MS diagnosis, time on DMT, baseline DMT, and ambulation status at age 60.
178 of 600 patients discontinued DMT, and 89.3% (n = 159) of those who discontinued remained off DMT. Only the EQ-5D mixed-effects linear regression model with the interaction term was statistically significant (omnibus p-value = 0.043). The slope relating time to EQ-5D was significantly different when comparing continuers to DBD (0.009, 95% CI 0.002-0.016, p-value = 0.015). The slopes were not significantly different when comparing continuers to DAD, or when comparing the before and after discontinuation slopes among the discontinuers. With the interaction term removed, there were no significant differences between the three groups for any other outcome.
Most patients over age 60 who discontinued DMT remained off treatment. Among the outcomes, only EQ-5D demonstrated significant differences over time, with continuers having lower quality of life scores compared to DBD. There were no significant group differences in PS, T25FW and PHQ-9. Overall, stopping DMT appears to have minimal effect on outcomes over the study period in patients over age 60.
继续免疫调节疾病修正疗法（DMT）在老年多发性硬化症（MS）患者中的风险效益比尚不清楚。迄今为止，只有关于 DMT 停药的回顾性观察研究已经发表。在这些研究中，DMT 的停药仅基于疾病的稳定性，并且患者经常需要重新开始治疗。我们之前的研究表明，考虑年龄因素时，DMT 的停药成功率更高。此外，尚未探讨停止 DMT 对患者生活质量的影响。本研究的目的是确定在年龄超过 60 岁的 MS 患者中，继续 DMT 与停止 DMT（基于疾病稳定性）相比，使用患者报告的结局（欧洲生活质量 5 维度（EQ-5D）指数、表现量表（PS）和患者健康问卷（PHQ9））和行走速度（25 英尺定时行走）的时间变化。
我们进行了一项回顾性观察研究，从我们的 MS 诊所中确定了年龄在 60 岁或以上且 DMT 治疗时间超过 2 年的患者。我们通过创建单独的混合效应线性回归模型来比较治疗组（继续治疗组、停药前（DBD）停药组和停药后（DAD）停药组）之间的随时间变化的结果，该模型包括治疗组和时间与研究结局轨迹之间的交互项。自变量是从 60 岁起的时间和治疗组，具有以下协变量：诊断时年龄、性别、MS 诊断时的病程、DMT 时间、基线 DMT 和 60 岁时的活动能力。
在 600 名患者中，有 178 名患者停止了 DMT，其中 89.3%（n=159）停止治疗的患者仍未接受 DMT。只有包含交互项的 EQ-5D 混合效应线性回归模型具有统计学意义（总体 p 值=0.043）。与 DBD 相比，与时间相关的 EQ-5D 斜率差异具有统计学意义（0.009，95%CI 0.002-0.016，p 值=0.015）。与 DAD 相比，继续治疗组和停药后组之间的斜率没有显著差异，或在停药后组中，前后斜率之间也没有显著差异。去除交互项后，在任何其他结局中，三组之间均无显著差异。
大多数年龄超过 60 岁停止 DMT 的患者仍未接受治疗。在这些结果中，只有 EQ-5D 在时间上显示出显著差异，与 DBD 相比，继续治疗组的生活质量评分较低。PS、T25FW 和 PHQ-9 无显著组间差异。总体而言，在年龄超过 60 岁的患者中，停止 DMT 在研究期间对结局的影响似乎很小。
