Department of Pharmacy, University of Ljubljana, Ljubljana, Slovenia.
Division of Neurology, Multiple Sclerosis Centre, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Curr Med Res Opin. 2023 Nov;39(11):1489-1496. doi: 10.1080/03007995.2023.2265299. Epub 2023 Oct 9.
Multiple sclerosis is a chronic, demyelinating inflammatory disease of the central nervous system. Medication persistence is defined as an interval between the initiation and last dose of the applied medication and presents a useful surrogate marker of a stable disease course. This observational study aimed to evaluate medication persistence and discontinuation reasons in Slovenian people with multiple sclerosis treated with dimethyl fumarate.
Our retrospective cohort study evaluated people with relapsing-remitting multiple sclerosis treated with dimethyl fumarate as an initial monotherapy or switched from injectable disease-modifying therapy medication between 2014 and 2021. Medication dispenses were extracted from the Slovenian National Institute of Public Health Outpatient Medication Database. The medication persistence criterion was based on the treatment gap. Patients exceeding a 60-day gap were considered nonpersistent. The median time to discontinuation was assessed using survival analyses. Considering discontinuation reasons, patients were further divided into safety and inefficacy groups. Due to the high probability of adverse effects, patients exceeding a 60-day gap were included in the safety group, but definite discontinuation reason remains unknown. The impact of covariates was evaluated by Cox regression.
A total of 269 patients were included (183 women, mean age 37 years). During the 7-year follow-up period, 123 (45.7%) patients discontinued treatment. The median time to discontinuation was 5.6 years. After 1, 2, and 5 years of treatment, 84%, 77%, and 57% of patients were found to be persistent, respectively. All patients older than 30 years ( = 0.0013) and among them, those in the inefficacy group ( = 0.037) were more likely to be persistent.
The results of our study proved a high persistence rate among our patients. The most frequent discontinuation reason was gastrointestinal adverse effects. Medication persistence requires interventions in younger patients with an unstable disease course.
多发性硬化症是一种中枢神经系统的慢性脱髓鞘炎症性疾病。药物维持治疗定义为起始治疗和最后一次用药之间的时间间隔，是疾病稳定的有用替代标志物。本观察性研究旨在评估接受二甲基富马酸治疗的斯洛文尼亚多发性硬化症患者的药物维持治疗和停药原因。
本回顾性队列研究评估了 2014 年至 2021 年间接受二甲基富马酸初始单药治疗或从注射用疾病修正治疗药物转换的复发缓解型多发性硬化症患者。从斯洛文尼亚国家公共卫生门诊药物数据库中提取药物配给情况。药物维持治疗的标准基于治疗间隙。治疗间隙超过 60 天的患者被认为是不持续的。采用生存分析评估停药的中位时间。考虑到停药原因，患者进一步分为安全性和无效性两组。由于不良反应的可能性较高，治疗间隙超过 60 天的患者被归入安全性组，但确切的停药原因尚不清楚。采用 Cox 回归评估协变量的影响。
共纳入 269 例患者（183 例女性，平均年龄 37 岁）。在 7 年的随访期间，123 例（45.7%）患者停药。停药的中位时间为 5.6 年。治疗 1、2 和 5 年后，分别有 84%、77%和 57%的患者被发现持续治疗。所有年龄大于 30 岁的患者（ = 0.0013），其中疗效不佳组（ = 0.037）更有可能持续治疗。
本研究结果证明了我们的患者中维持治疗率较高。最常见的停药原因是胃肠道不良反应。需要对疾病病程不稳定的年轻患者进行药物维持治疗干预。
