Mitsikostas Dimos D, Orologas Anastasios, Dardiotis Efthimios, Fakas Nikolaos, Doskas Triantafyllos, Karageorgiou Klimentini, Maltezou Maria, Iliopoulos Ioannis, Vikelis Michail, Grigoriadis Nikolaos
Department of Neurology, Athens Naval Hospital, Athens, Greece.
A' Department of Neurology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.
Adv Ther. 2023 May;40(5):2217-2233. doi: 10.1007/s12325-022-02388-8. Epub 2023 Mar 10.
Fingolimod is the first approved oral therapy for relapsing-remitting multiple sclerosis (RRMS). The present study aimed to further characterize fingolimod's safety profile, and to assess the patient-reported treatment satisfaction and impact of fingolimod on the quality of life (QoL) of patients with multiple sclerosis (MS) treated in routine care in Greece.
This was a multicenter, prospective, observational, 24-month study conducted in Greece by hospital-based and private practice neurologists who specialize in MS. Eligible patients had initiated fingolimod within 15 days in accordance with the locally approved label. Safety outcomes included any adverse event (AE) observed during the study period and efficacy outcomes included both objective (disability progression and 2-year annualized relapse rate) and patient-reported assessments (Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 and the EuroQol (EQ)-5-dimension (5D) 3-level instruments).
A total of 489 eligible patients (age 41.2 ± 9.8 years; 63.7% female; 4.2% treatment-naive) were exposed to fingolimod for a median of 23.7 months. During the observation period, 20.5% of the participants experienced 233 AEs. Lymphopenia (8.8%), leukopenia (4.2%), hepatic enzyme increased (3.4%), and infections (3.0%) were the most common. Most patients (89.3%) did not experience disability progression; the 2-year annualized relapse rate decreased by 94.7% compared to baseline. The median EQ-visual analogue scale (VAS) was 74.5 at month 24 vs. 65.0 at enrollment (p < 0.001) and the EQ-5D index score was 0.80 vs. 0.78, respectively. Significant improvements were noted in the TSQM global satisfaction and effectiveness domain scores between 6 and 24 months post enrollment (median scores at month 24, 71.4 and 66.7, respectively) (p < 0.001). Significant increases from enrollment to the 24th month were also noted in the patients' global satisfaction and effectiveness domain scores [mean change of 7.4 ± 17.7 (p = 0.005) and mean increase of 5.4 ± 16.2) (p = 0.043), respectively].
In the real-world setting of Greece, fingolimod demonstrates a clinical benefit and a predictable and manageable safety profile, which contribute towards high patient-reported treatment satisfaction and improvements in the QoL of patients with MS.
芬戈莫德是首个获批用于复发缓解型多发性硬化症（RRMS）的口服疗法。本研究旨在进一步明确芬戈莫德的安全性概况，并评估患者报告的治疗满意度以及芬戈莫德对在希腊接受常规治疗的多发性硬化症（MS）患者生活质量（QoL）的影响。
这是一项在希腊开展的多中心、前瞻性、观察性、为期24个月的研究，由专门从事MS治疗的医院神经科医生和私人执业神经科医生进行。符合条件的患者已根据当地批准的标签在15天内开始使用芬戈莫德。安全性结局包括研究期间观察到的任何不良事件（AE），疗效结局包括客观指标（残疾进展和2年的年化复发率）以及患者报告的评估指标（药物治疗满意度问卷（TSQM）v1.4和欧洲五维健康量表（EQ）-5维度（5D）3级工具）。
共有489名符合条件的患者（年龄41.2±9.8岁；63.7%为女性；4.2%为初治患者）接受了芬戈莫德治疗，中位治疗时间为23.7个月。在观察期内，20.5%的参与者经历了233次不良事件。淋巴细胞减少（8.8%）、白细胞减少（4.2%）、肝酶升高（3.4%）和感染（3.0%）最为常见。大多数患者（89.3%）未出现残疾进展；与基线相比，2年的年化复发率降低了94.7%。在第24个月时，EQ视觉模拟量表（VAS）的中位数为74.5，而在入组时为65.（p<0.001），EQ-5D指数评分分别为0.80和0.78。入组后6至24个月期间，TSQM总体满意度和有效性领域得分有显著改善（第24个月时的中位数得分分别为71.4和66.7）（p<0.001）。从入组到第24个月，患者的总体满意度和有效性领域得分也有显著提高[平均变化分别为7.4±17.7（p=0.005）和平均提高5.4±16.2（p=0.043）]。
在希腊的实际临床环境中，芬戈莫德显示出临床益处以及可预测和可管理的安全性概况，这有助于提高患者报告的治疗满意度并改善MS患者的生活质量。
