克拉德滨与芬戈莫德治疗高活性复发性多发性硬化症的比较疗效:MERLYN (MavEnclad Real worLd Comparative efficacY non-iNterventional)研究(P7-4.005)

摘要目的:对于高度活动性复发性多发性硬化症(HA-RMS)患者，获得口腔疾病改善疗法(dmt)的实际比较疗效数据是很重要的。

背景:主要目的是比较接受克拉德里滨片(CladT)或fingolimod单药治疗的HA-RMS患者的复发率。本文报道的次要目标包括比较额外的复发结果、治疗切换和停药。

设计/方法:在英国和德国进行了一项多中心，回顾性图表回顾研究，以评估CladT与芬戈莫德在符合条件的HA-RMS患者治疗的前12个月的疗效。CladT与fingolimod的调整年化复发率(ARR)比设定为1.2的非劣效性。采用处理加权逆概率建立平衡处理组。医生确认的复发、扩展残疾状态量表(EDSS)评分和磁共振成像(MRI)数据也被检查。

结果:纳入1095例患者:610例使用CladT, 485例使用fingolimod。在治疗开始后的12个月期间，1例(0.2%)开始使用CladT的患者切换到另一种DMT，而10例(2.1%)fingolimod患者切换到另一种DMT, 7例(1.5%)停止治疗。CladT的ARR为0.10(95%可信区间[CI]: 0.07-0.14)， fingolimod的ARR为0.14 (95% CI: 0.10 - 0.20)。调整后的ARR比为0.68 (95% CI: 0.42-1.11)，在数值上对CladT有利，95% CI上限在非劣效性范围内。两组间首次复发时间和无复发患者比例相似。

结论:在治疗的前12个月，CladT在HA-RMS患者的复发活性方面显示出与芬戈莫德相当的有效性。芬戈莫德组治疗切换/停药更为常见。未来的研究应该调查治疗后12个月的有效性和治疗持久性。

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