Al-Hashmi Ghaida K H, Al-Asmi Abdullah, Islam M Mazharul, Al-Zakwani Ibrahim, Butt Mehwish, Al-Qassabi Ahmed, Al-Abri Haifa, Gujjar Arunodaya R
Department of Medicine, College of Medicine & Health Sciences, Sultan Qaboos University and Sultan Qaboos University Hospital, University Medical City.
Department of Statistics, College of Science, Sultan Qaboos University, Muscat, Oman.
Sultan Qaboos Univ Med J. 2025 May 2;25(1):225-232. doi: 10.18295/2075-0528.2829.
This study aimed to evaluate the effectiveness and safety of fingolimod in Omani multiple sclerosis (MS) patients. Fingolimod is one of the oral drugs used to treat MS. However, there is limited information on its effectiveness and safety among the Omani population.
This retrospective real-world study included 65 Omani MS patients who received fingolimod therapy from 2012 to 2021 at a single tertiary centre in Oman. Data were collected between August and November 2021. Various measures were used to evaluate the effectiveness and safety of fingolimod.
Out of 65 MS patients included in the study, 51 (79%) were female. The median duration of fingolimod use was 3.6 ± 2.5 years. The results of the last follow-up visit indicate that the median annualised relapse rate decreased by 84% and relapse-free rate (RFR) increased to 90%, with only a minimal (13%) increase in the expanded disability status. The median number of gadolinium-enhanced lesions in the brain and spine decreased significantly by 88% and 67%, respectively, while the new or enlarged T2 lesions in the brain significantly decreased by 62% (P < 0.050) over the treatment period. The most common side effect was bradycardia (32%). Patient age and age at treatment initiation were significant predictors of RFR (P < 0.050).
This study suggests that the effectiveness and safety profiles of fingolimod in Omani MS patients are similar to those determined by standard clinical trials and real-world retrospective studies.
本研究旨在评估芬戈莫德对阿曼多发性硬化症（MS）患者的有效性和安全性。芬戈莫德是用于治疗MS的口服药物之一。然而，关于其在阿曼人群中的有效性和安全性的信息有限。
这项回顾性真实世界研究纳入了65例阿曼MS患者，他们于2012年至2021年在阿曼的一个单一三级中心接受了芬戈莫德治疗。数据收集于2021年8月至11月之间。采用了各种措施来评估芬戈莫德的有效性和安全性。
在纳入研究的65例MS患者中，51例（79%）为女性。芬戈莫德的中位使用时间为3.6±2.5年。最后一次随访结果表明，年化复发率中位数下降了84%，无复发率（RFR）提高到90%，而扩展残疾状态仅略有增加（13%）。脑和脊柱中钆增强病灶的中位数分别显著下降了88%和67%，而在治疗期间，脑中新增或扩大的T2病灶显著减少了62%（P<0.050）。最常见的副作用是心动过缓（32%）。患者年龄和开始治疗时的年龄是RFR的显著预测因素（P<0.050）。
本研究表明，芬戈莫德在阿曼MS患者中的有效性和安全性概况与标准临床试验和真实世界回顾性研究所确定的相似。
