Background: There is a lack of head-to-head studies comparing the efficacy of fingolimod (FIN) and natalizumab (NTZ) as second-line therapy for relapsing-remitting multiple sclerosis (RRMS). Methods: Multicenter, observational study, in which, information of 388 patients randomly selected and treated with FIN or NTZ in routine clinical practice was retrospectively collected with the main objective of comparing the annualized relapse rate (ARR) over the first year, after FIN or NTZ treatment initiation. Results: Mean ARR during the first year of treatment was 0.28 in FIN group and 0.12 in NTZ group (p = 0.0064); nevertheless, the difference between groups lost statistical significance when the propensity score analysis was performed. Time to disability progression was similar in both treatment groups (12.3 ± 6.7 months in FIN, and 12.8 ± 0.1 months in NTZ; p = 0.4654). Treatment persistence after the first year of treatment was higher in patients treated with FIN (95%) than in those treated with NTZ (84%; p = 0.0014). Conclusions: After 12 months of treatment, both FIN and NTZ reduced the ARR, but ARR percent reduction was significantly higher with NTZ. Treatment persistence was higher in patients receiving FIN.

中文翻译：

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芬戈莫德与那他珠单抗作为西班牙复发缓解型多发性硬化症二线治疗的有效性：二线 GATE 研究

背景：缺乏比较芬戈莫德 (FIN) 和那他珠单抗 (NTZ) 作为二线治疗复发缓解型多发性硬化症 (RRMS) 疗效的头对头研究。方法：多中心、观察性研究，回顾性收集随机选择并在常规临床实践中接受 FIN 或 NTZ 治疗的 388 例患者的信息，主要目的是比较 FIN 或 NTZ 后第一年的年复发率（ARR）。 NTZ 治疗开始。结果：治疗第一年的平均 ARR，FIN 组为 0.28，NTZ 组为 0.12（p = 0.0064）；然而，当进行倾向评分分析时，组之间的差异失去了统计显着性。两个治疗组的残疾进展时间相似（FIN 为 12.3 ± 6.7 个月，12.8 ± 0. 在NTZ 1个月；p = 0.4654）。接受 FIN 治疗的患者（95%）在第一年治疗后的治疗持续性高于接受 NTZ 治疗的患者（84%；p = 0.0014）。结论：治疗 12 个月后，FIN 和 NTZ 均降低了 ARR，但 NTZ 的 ARR 降低百分比显着更高。接受 FIN 的患者的治疗持续性更高。