Boz Cavit, Ozakbas Serkan, Terzi Murat, Karabudak Rana, Sevim Serhan, Turkoglu Recai, Soysal Aysun, Balcı Belgin Petek, Efendi Hüsnü, Turan Ömer Faruk, Yüceyar Nur, Yetkin Mehmet Fatih, Karahan Serap Zengin, Demirkıran Meltem, Guler Sibel, Agan Kadriye, Kıylıoğlu Nefati, Baba Cavid, Tuncer Asli, Köseoğlu Mesrure
Department of Neurology, Karadeniz Technical University Medical Faculty, 61080, Trabzon, Turkey.
Department of Neurology, Dokuz Eylul University, Izmir, Turkey.
Neurol Sci. 2023 Jun;44(6):2121-2129. doi: 10.1007/s10072-023-06608-z. Epub 2023 Jan 23.
Fingolimod, natalizumab, and ocrelizumab are commonly used in the second-line treatment of relapsing-remitting multiple sclerosis (RRMS). However, these have only been compared in observational studies, not in controlled trials, with limited and inconclusive results being reported. A comparison of their effect on relapse and disability in a real-world setting is therefore needed.
The objective of this study was to compare the efficacy of fingolimod, natalizumab, and ocrelizumab in reducing disease activity in RRMS.
This multicenter, retrospective observational study was carried out with prospectively collected data from 16 centers. All consecutive RRMS patients treated with fingolimod, natalizumab, and ocrelizumab were included. Data for relapses, Expanded Disability Status Scale (EDSS) scores, and brain magnetic resonance imaging (MRI) scans were collected. Patients were matched using propensity scores. Annualized relapse rates (ARR), time to first relapse, and disability accumulation were compared.
Propensity score matching retained 736 patients in the fingolimod versus 370 in the natalizumab groups, 762 in the fingolimod versus 434 in the ocrelizumab groups, and 310 in the natalizumab versus 310 in the ocrelizumab groups for final analyses. Mean ARR decreased markedly from baseline after treatment in all three treatment groups. Mean on-treatment ARR was lower in natalizumab-treated patients (0.09, 95% confidence interval (CI), 0.07-0.12) than in those treated with fingolimod (0.17, 0.15-0.19, p<0.001), ocrelizumab (0.08, 0.06-0.11), and fingolimod (0.14, 0.12-0.16, p=0.001). No significant difference was observed in mean on-treatment ARR between patients treated with natalizumab (0.08, 0.06-0.11) and ocrelizumab (0.09, 0.07-0.12, p=0.54). Compared to fingolimod, the natalizumab and ocrelizumab groups exhibited a higher percentage of relapse-free patients and a lower percentage of MRI-active patients at year 1. No significance differences in disability accumulation were determined between the therapies.
Natalizumab and ocrelizumab exhibited similar effects on relapse control, and both were associated with better relapse control than fingolimod. The effects of the three therapies on disability outcomes were similar.
芬戈莫德、那他珠单抗和奥瑞珠单抗常用于复发缓解型多发性硬化症（RRMS）的二线治疗。然而，这些药物仅在观察性研究中进行了比较，而非在对照试验中，报道的结果有限且尚无定论。因此，需要在真实世界环境中比较它们对复发和残疾的影响。
本研究的目的是比较芬戈莫德、那他珠单抗和奥瑞珠单抗在降低RRMS疾病活动度方面的疗效。
本多中心回顾性观察性研究使用了前瞻性收集的来自16个中心的数据。纳入所有连续接受芬戈莫德、那他珠单抗和奥瑞珠单抗治疗的RRMS患者。收集复发、扩展残疾状态量表（EDSS）评分和脑磁共振成像（MRI）扫描的数据。使用倾向评分对患者进行匹配。比较年化复发率（ARR）、首次复发时间和残疾累积情况。
倾向评分匹配后，最终分析中芬戈莫德组保留736例患者，那他珠单抗组保留370例；芬戈莫德组保留762例患者，奥瑞珠单抗组保留434例；那他珠单抗组保留310例患者，奥瑞珠单抗组保留310例。所有三个治疗组治疗后平均ARR均较基线显著下降。那他珠单抗治疗患者的平均治疗期ARR（0.09，95%置信区间（CI），0.07 - 0.12）低于接受芬戈莫德治疗的患者（0.17，0.15 - 0.19，p<0.001）、奥瑞珠单抗治疗的患者（0.08，0.06 - 0.11）以及芬戈莫德治疗患者（0.14，0.12 - 0.16，p = 0.001）。接受那他珠单抗治疗的患者（0.08）与奥瑞珠单抗治疗的患者（0.09，0.07 - 0.12，p = 0.54）之间的平均治疗期ARR未观察到显著差异。与芬戈莫德相比，那他珠单抗组和奥瑞珠单抗组在第1年时无复发患者的比例更高，MRI有活动的患者比例更低。各治疗方法在残疾累积方面未发现显著差异。
那他珠单抗和奥瑞珠单抗在复发控制方面表现出相似的效果，且两者在复发控制方面均优于芬戈莫德。三种治疗方法对残疾结局的影响相似。
