Background: Natalizumab (NTZ) and fingolimod (FTY) are second-line disease modifying treatments (DMTs) approved for Relapsing - Remitting Multiple Sclerosis (RRMS). Few studies are available on a direct comparison between NTZ and FTY, based on post-marketing experience, with conflicting results and reporting relatively short follow-up period. Aim: We hereby report real-world experience of a MS Center with respect to NTZ vs. FTY comparison in terms of efficacy and safety, referencing long-term follow-up. Methods: We used retrospective data for all patients that received 2nd-line treatment NTZ (since May 2007) or FTY (since September 2011). Primary endpoints were, among others, annual EDSS score (mean change from baseline), time to disability worsening or improvement, Annualized Relapse Rate (ARR) after 12 and 24 months and upon total treatment duration, time to first relapse and time to radiological progression. Results: A total of 138 unmatched patients, 84 treated with NTZ and 54 treated with FTY were included. Following Propensity Score (PS) matching, 31 patients in each group were retained. Mean follow-up period for NTZ- and FTY-treated patients was 4.43 ± 0.29 and 3.59 ± 0.32 years (p = 0.057), respectively. In the matched analysis, time to disability improvement and time to disability worsening was comparable between groups. A higher proportion of patients remained free of relapse under NTZ, compared to FTY (Log Rank test p = 0.021, HR: 0.25, 95% CI: 0.08-0.8), as well as free of MRI activity (Log Rank test p = 0.006, HR: 0.26, 95% CI: 0.08-0.6). Treatment discontinuation due to MRI activity was significantly higher for FTY-treated patients compared to NTZ (Log Rank test p = 0.019, HR: 0.12, 95% CI: 0.05-0.76). Conclusion: Our results indicate toward NTZ superiority with respect to relapse and MRI activity outcomes. The fact that NTZ-treated patients may achieve long-standing clinical and radiological remission points toward the need for long follow-up data.

中文翻译：

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Natalizumab 与芬戈莫德在高度活动性复发缓解型多发性硬化症患者中的长期疗效结果：来自多发性硬化症参考中心的真实数据。

背景：那他珠单抗 (NTZ) 和芬戈莫德 (FTY) 是被批准用于复发-缓解型多发性硬化症 (RRMS) 的二线疾病改善疗法 (DMT)。很少有研究根据上市后经验直接比较 NTZ 和 FTY，结果相互矛盾，并且报告的随访期相对较短。目的：我们在此报告 MS 中心在 NTZ 与 FTY 有效性和安全性比较方面的实际经验，并参考长期随访。方法：我们使用了所有接受二线治疗 NTZ（自 2007 年 5 月）或 FTY（自 2011 年 9 月）的患者的回顾性数据。主要终点包括年度 EDSS 评分（与基线相比的平均变化）、残疾恶化或改善的时间、12 和 24 个月后的年复发率 (ARR) 以及总治疗时间、首次复发时间和影像学进展时间。结果：共纳入未配对患者138例，其中NTZ治疗84例，FTY治疗54例。在进行倾向评分（PS）匹配后，每组保留 31 名患者。NTZ 和 FTY 治疗患者的平均随访时间分别为 4.43 ± 0.29 和 3.59 ± 0.32 年（p = 0.057）。在匹配分析中，组间残疾改善时间和残疾恶化时间具有可比性。与 FTY（Log Rank test p = 0.021, HR: 0.25, 95% CI: 0.08-0.8）相比，NTZ 治疗下没有复发的患者比例更高，并且没有 MRI 活动（Log Rank test p = 0.006） , HR: 0.26, 95% CI: 0.08-0.6)。与 NTZ 相比，FTY 治疗的患者因 MRI 活动而中断治疗的比例显着更高（Log Rank 检验 p = 0.019，HR：0.12，95% CI：0.05-0.76）。结论：我们的结果表明 NTZ 在复发和 MRI 活动结果方面的优势。NTZ 治疗的患者可能实现长期临床和放射学缓解的事实表明需要长期随访数据。