Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, via Irnerio 48, 40126 Bologna, Italy.
Former Professor of Pharmacology at the Alma Mater Studiorum University di Bologna, Italy.
J Neurol Sci. 2024 Aug 15;463:123132. doi: 10.1016/j.jns.2024.123132. Epub 2024 Jul 10.
The most prevalent disease course of Multiple Sclerosis (MS) is relapsing remitting multiple sclerosis (RRMS). Fingolimod (Gilenya®) was the first oral disease-modifying therapy to RRMS. Patients affected by MS require long-term treatment, making the ongoing evaluation of the safety profile of fingolimod imperative. The aim of this study was to analyze the post-marketing pharmacovigilance data of fingolimod in Europe. Data of 12-year period (1 January 2011-19 June 2023) were obtained from EudraVigilance, and a descriptive analysis using drug-reaction pairs was performed. A total of 22,957 reports were collected. The most reported adverse events (AEs) were related to nervous system disorders SOC (multiple sclerosis relapse n = 2271; 3.51%, headache n = 921; 1.42%, central nervous system lesion n = 893; 1,38%, dizziness 769; 1,19%, hypoaesthesia 487; 0.75% and multiple sclerosis 449; 0.69%), followed by investigations (lymphocyte count decreased n = 1648; 2.55%, white blood cell count decreased n = 833; 1.29%), blood and lymphatic system disorder (lymphopenia n = 1146; 1.77%), and general disorders and administration site condition (fatigue n = 1106; 1.71%, gait disturbance 564; 0.87%). A percentage of 23.00% of serious adverse events (SAEs), among the most reported were multiple sclerosis relapse (n = 2271; 15.27%), macular oedema (n = 793; 5.33%), bradycardia (n = 678; 4.56%), leukopenia (n = 533; 3.58%), and multiple sclerosis (n = 449; 3.02%). Most of AEs were non-serious, some SAEs related to cardiac, ophthalmic and infectious disorders emerged: their prevalence, along with the alignment of reported AEs with existing literature, supports the overall safety of fingolimod. Considering the rare and long-term ADRs that may arise in patients chronically treated for MS, continuous pharmacovigilance remains essential.
多发性硬化症（MS）最常见的疾病过程是复发缓解型多发性硬化症（RRMS）。芬戈莫德（Gilenya®）是首个用于 RRMS 的口服疾病修正治疗药物。受 MS 影响的患者需要长期治疗，因此必须持续评估芬戈莫德的安全性概况。本研究旨在分析欧洲上市后药物警戒数据中的芬戈莫德。从 EudraVigilance 获得了 12 年期间（2011 年 1 月 1 日至 2023 年 6 月 19 日）的数据，并使用药物反应对进行了描述性分析。共收集了 22957 份报告。报告最多的不良事件（AE）与神经系统疾病类别相关（多发性硬化症复发 n=2271；3.51%，头痛 n=921；1.42%，中枢神经系统病变 n=893；1.38%，头晕 n=769；1.19%，感觉迟钝 n=487；0.75%和多发性硬化 n=449；0.69%），其次是检查（淋巴细胞计数降低 n=1648；2.55%，白细胞计数降低 n=833；1.29%），血液和淋巴系统疾病（淋巴细胞减少症 n=1146；1.77%）和一般疾病和给药部位状况（疲劳 n=1106；1.71%，步态障碍 n=564；0.87%）。严重不良事件（SAE）的报告比例为 23.00%，其中报告最多的是多发性硬化症复发（n=2271；15.27%）、黄斑水肿（n=793；5.33%）、心动过缓（n=678；4.56%）、白细胞减少症（n=533；3.58%）和多发性硬化症（n=449；3.02%）。大多数 AE 为非严重，一些与心脏、眼科和传染病有关的 SAE 出现：它们的患病率，以及与现有文献报告的 AE 的一致性，支持芬戈莫德的总体安全性。考虑到慢性治疗 MS 患者可能出现的罕见和长期不良反应，持续进行药物警戒仍然至关重要。
