Epidemiology and Statistics Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna 40139, Italy.
Department of Epidemiology of the Lazio Regional Health Service, ASL Roma 1, Via Cristoforo Colombo, 112-00147 Roma, Italy.
Mult Scler Relat Disord. 2023 Dec;80:105094. doi: 10.1016/j.msard.2023.105094. Epub 2023 Oct 24.
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring complex diagnostic and therapeutic management. Treatment with Disease Modifying Drugs (DMDs) is aimed at reducing relapse rate and disease disability. Few real-world, population-based data are available on the impact of adherence on relapse rate. The objective of this study was to assess the impact of adherence to DMDs on relapses in a real-world Italian setting.
Population-based cohort study. People with MS (PwMS) older than 18 years and residing in the Emilia-Romagna region, Northern Italy, were identified through administrative databases using a validated algorithm. A Cox regression model with a time-varying exposure was performed to assess the association between level of adherence to DMDs and relapses over a 5-year period.
A total of 2,528 PwMS receiving a first prescription of DMDs between 2015 and 2019 were included (average age of 42, two-thirds female). Highly adherent PwMS had a 25 % lower hazard of experiencing moderate or severe relapses than non-adherent PwMS (Hazard Ratio 0.75, 95 % CI 0.58 to 0.98), after adjusting for age and sex. Several sensitivity analyses supported the main result.
The results of our study support the hypothesis that a high level of DMD adherence in MS is associated with a lower risk of moderate or severe relapse. Therefore, choosing the DMD with which to start drug treatment and recommending adherence to treatment appear to be crucial aspects involving both physicians and patients.
多发性硬化症（MS）是一种中枢神经系统的慢性炎症性疾病，需要进行复杂的诊断和治疗管理。使用疾病修正药物（DMD）治疗的目的是降低复发率和疾病残疾程度。关于药物依从性对复发率的影响，仅有少量真实世界、基于人群的数据。本研究的目的是评估意大利真实环境中药物依从性对复发的影响。
基于人群的队列研究。使用经过验证的算法，通过行政数据库在意大利北部艾米利亚-罗马涅地区识别出年龄大于 18 岁且居住在该地区的多发性硬化症患者（PwMS）。采用时变暴露的 Cox 回归模型评估 5 年内 DMD 药物依从水平与复发之间的关联。
共纳入 2528 名 2015 年至 2019 年期间首次接受 DMD 治疗的 PwMS（平均年龄 42 岁，三分之二为女性）。与不依从者相比，高度依从者经历中重度复发的风险降低了 25%（风险比 0.75，95%置信区间 0.58 至 0.98），调整年龄和性别后。几项敏感性分析支持了主要结果。
我们的研究结果支持以下假设，即多发性硬化症中较高的 DMD 依从性与较低的中重度复发风险相关。因此，选择开始药物治疗的 DMD 并建议患者坚持治疗似乎是涉及医生和患者的两个关键方面。
