Alroughani R, Ahmed S F, Behbehani R, Al-Hashel J
Division of Neurology, Department of Medicine, Amiri Hospital, Sharq, Kuwait; Neurology Clinic, Department of Medicine, Dasman Diabetes Institute, Dasman, Kuwait.
Department of Neurology, Ibn Sina Hospital, Kuwait City, Kuwait; Department of Neurology & Psychiatry, Al-Minia University Hospital, Minia, Egypt.
Clin Neurol Neurosurg. 2014 Apr;119:17-20. doi: 10.1016/j.clineuro.2014.01.007. Epub 2014 Jan 21.
Post-marketing studies are important to confirm what was established in clinical trials, and to assess the intermediate and long-term efficacy and safety.
To assess efficacy and safety of fingolimod in multiple sclerosis (MS) in Kuwait.
We retrospectively evaluated MS patients using the MS registries in 3 MS clinics. Relapsing remitting MS patients according to revised 2010 McDonald criteria who had been treated with fingolimod for at least 12 months were included. Primary endpoint was proportion of relapse-free patients at last follow-up. Secondary endpoints were mean change in EDSS and proportion of patients with MRI activity (gadolinium-enhancing or new/enlarging T2 lesions).
76 patients met the inclusion criteria. Mean age and mean disease duration were 34.43 and 7.82 years respectively. Mean duration of exposure to fingolimod was 18.50 months. Proportion of relapse-free patients was 77.6% at last follow-up. Mean EDSS score significantly improved (2.93 versus 1.95; p<0.0001) while 17.1% of patients continued to have MRI activity versus 77.6% at baseline (p<0.0001). Four patients stopped fingolimod due to disease breakthrough (n=3) and lymphadenitis (n=1).
Fingolimod is safe and effective in reducing clinical and radiological disease activity in relapsing remitting MS patients. Our results are comparable to reported results of phase III studies.
上市后研究对于确认临床试验中所确立的内容，以及评估中长期疗效和安全性至关重要。
评估芬戈莫德在科威特多发性硬化症（MS）患者中的疗效和安全性。
我们通过3家MS诊所的MS登记系统对MS患者进行了回顾性评估。纳入了符合2010年修订的麦克唐纳标准、接受芬戈莫德治疗至少12个月的复发缓解型MS患者。主要终点是最后一次随访时无复发患者的比例。次要终点是扩展残疾状态量表（EDSS）的平均变化以及有MRI活动（钆增强或新出现/扩大的T2病变）的患者比例。
76例患者符合纳入标准。平均年龄和平均病程分别为34.43岁和7.82年。芬戈莫德的平均暴露时间为18.50个月。最后一次随访时无复发患者的比例为77.6%。EDSS平均评分显著改善（2.93对1.95；p<0.0001），而17.1%的患者仍有MRI活动，基线时这一比例为77.6%（p<0.0001）。4例患者因疾病进展（n = 3）和淋巴结炎（n = 1）停止使用芬戈莫德。
芬戈莫德在降低复发缓解型MS患者的临床和影像学疾病活动方面安全有效。我们的结果与III期研究报告的结果相当。
