Fingolimod real life experience in non-naive multiple sclerosis patients

Furkan Sarıdaş, Emine Rabia Koç, Güven Özkaya, Ömer Faruk Turan
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Abstract

Objectives: Fingolimod is approved in Turkey or the treatment of cases of multiple sclerosis (MS) which cannot be controlled with first-line treatments. There is limited information about its efficacy and safety in clinical practice in Turkey. The aim of this study was to evaluate the efficacy and safety of fingolimod treatment in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by the Multiple Sclerosis specialists of Bursa Uludağ University Department of Neurology. Methods: This is a single-center observational study evaluating 142 patients using fingolimod who were followed up for at least 12 months in our center between April 2015 and October 2022. Efficacy results were evaluated in terms of mean number of attacks, annualized relapse rate, relapse-free patient rate, disease progression, clinical and radiological disease activity, and no evidence of disease activity (NEDA-3). The safety outcomes are the rates of treatment-related severe adverse events and patients' continuation rates. Results: Over 12 months of treatment with fingolimod, the average number of attacks decreased by 94.6%, the annual relapse rate decreased by 87%, and most patients did not relapse (83.1%). Alongside this, in 76.4% of cases, there was no disability progression and in 83.3% of cases, magnetic resonance imaging (MRI) activation was not observed. Excluding replacement due to ineffectiveness, 89.4% of patients continued fingolimod therapy. Cardiac events, treatment-related infections and a decreased lymphocyte count were observed as side effects. Conclusion: In our center, switching from first-line treatments to fingolimod was effective in reducing disease activity in patients with multiple sclerosis.
非免疫性多发性硬化症患者的芬戈莫德真实体验
目的:芬戈莫德在土耳其获批用于治疗一线治疗无法控制的多发性硬化症(MS)病例。有关其在土耳其临床实践中的疗效和安全性的信息十分有限。本研究旨在评估由布尔萨乌鲁达大学神经内科多发性硬化症专家开具芬戈莫德处方的复发缓解型多发性硬化症患者接受芬戈莫德治疗的疗效和安全性:这是一项单中心观察性研究,评估了2015年4月至2022年10月期间在本中心随访至少12个月的142名使用芬戈莫德的患者。疗效结果从平均发作次数、年复发率、无复发患者率、疾病进展、临床和放射学疾病活动性以及无疾病活动性证据(NEDA-3)等方面进行评估。安全性结果是与治疗相关的严重不良事件发生率和患者继续治疗率:芬戈莫德治疗12个月后,患者的平均发作次数减少了94.6%,年复发率降低了87%,大多数患者没有复发(83.1%)。与此同时,76.4%的病例未出现残疾进展,83.3%的病例未观察到磁共振成像(MRI)激活。除去因无效而更换治疗方案的患者,89.4%的患者继续接受芬戈莫德治疗。副作用包括心脏事件、治疗相关感染和淋巴细胞计数下降:在我们中心,从一线治疗转为芬戈莫德治疗可有效减少多发性硬化症患者的疾病活动。
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