Boziki Marina, Bakirtzis Christos, Giantzi Virginia, Sintila Styliani-Aggeliki, Kallivoulos Stylianos, Afrantou Theodora, Nikolaidis Ioannis, Ioannidis Panagiotis, Karapanayiotides Theodoros, Koutroulou Ioanna, Parissis Dimitrios, Grigoriadis Nikolaos
2nd Neurological University Department, American Hellenic Educational Progressive Association (AHEPA) General Hospital, Aristotle University of Thessaloniki (A.U.TH.), Thessaloniki, Greece.
Front Neurol. 2021 Aug 23;12:699844. doi: 10.3389/fneur.2021.699844. eCollection 2021.
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. 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. 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. 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 ( = 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 = 0.021, HR: 0.25, 95% CI: 0.08-0.8), as well as free of MRI activity (Log Rank test = 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 = 0.019, HR: 0.12, 95% CI: 0.05-0.76). 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.
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）的二线疾病修正治疗药物（DMTs）。基于上市后经验，关于NTZ和FTY之间的直接比较的研究很少，结果相互矛盾且随访期相对较短。我们在此报告一个MS中心在NTZ与FTY疗效和安全性比较方面的真实世界经验，并参考长期随访情况。我们使用了所有接受二线治疗NTZ（自2007年5月起）或FTY（自2011年9月起）的患者的回顾性数据。主要终点包括年度扩展残疾状态量表（EDSS）评分（从基线的平均变化）、残疾恶化或改善的时间、12个月和24个月以及整个治疗期间后的年化复发率（ARR）、首次复发时间和影像学进展时间。总共纳入了138例未匹配的患者，其中84例接受NTZ治疗，54例接受FTY治疗。经过倾向得分（PS）匹配后，每组保留31例患者。NTZ治疗组和FTY治疗组的平均随访期分别为4.43±0.29年和3.59±0.32年（P = 0.057）。在匹配分析中，两组之间残疾改善时间和残疾恶化时间相当。与FTY相比，NTZ治疗下无复发的患者比例更高（对数秩检验P = 0.021，风险比：0.25，95%置信区间：0.08 - 0.8），以及无MRI活动的患者比例更高（对数秩检验P = 0.006，风险比：0.26，95%置信区间：0.08 - 0.6）。与NTZ相比，FTY治疗的患者因MRI活动导致的治疗中断显著更高（对数秩检验P = 0.019，风险比：0.12，95%置信区间：0.05 - 0.76）。我们的结果表明NTZ在复发和MRI活动结果方面具有优越性。NTZ治疗的患者可能实现长期临床和影像学缓解这一事实表明需要长期随访数据。
