Cohen Mikael, Mondot Lydiane, Bucciarelli Florence, Pignolet Béatrice, Laplaud David-Axel, Wiertlewski Sandrine, Brochet Bruno, Ruet Aurélie, Defer Gilles, Derache Nathalie, Vermersch Patrick, Zephir Hélène, Debouverie Marc, Mathey Guillaume, Berger Eric, Cappé Chrystelle, Labauge Pierre, Carra Clarisse, De Seze Jérôme, Bigaut Kevin, Brassat David, Lebrun-Frenay Christine
Service de Neurologie, CRCSEP, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.
Service de Radiologie, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.
Mult Scler. 2021 Sep;27(10):1556-1563. doi: 10.1177/1352458520969145. Epub 2020 Oct 30.
There are few head-to-head studies to compare highly active treatments in multiple sclerosis (MS).
The aim of this study was to compare the effectiveness between natalizumab (NTZ) and fingolimod (FTY) in active relapsing-remitting MS.
Best Escalation STrategy in Multiple Sclerosis (BEST-MS) is a multicentric, prospective study with a 12-month follow-up including patients with active MS. Treatment choice was at the discretion of physician. Clinical and magnetic resonance imaging (MRI) data were collected at baseline and at 12 months. The primary outcome was the proportion of patients reaching no evidence of disease activity (NEDA) at 12 months. Secondary outcomes included annualized relapse rate and MRI activity.
A total of 223 patients were included (NTZ: 109 and FTY: 114). Treatment groups were well balanced at baseline. Proportion of NEDA patients was 47.8% in NTZ group versus 30.4% in FTY group ( = 0.015). This superiority was driven by annualized relapse rate and MRI activity. In the multivariate analysis, treatment group was the only factor associated with NEDA at 12 months with a lower probability in FTY group (odds ratio (OR) = 0.49, = 0.029).
BEST-MS is a prospective study that compared head-to-head the effectiveness of NTZ and FTY in active relapsing-remitting MS. Our results suggest a superiority of NTZ over FTY.
很少有直接比较治疗多发性硬化症（MS）的高效疗法的研究。
本研究旨在比较那他珠单抗（NTZ）和芬戈莫德（FTY）在活动性复发缓解型MS中的疗效。
多发性硬化症最佳升级策略（BEST-MS）是一项多中心前瞻性研究，对活动性MS患者进行为期12个月的随访。治疗方案由医生决定。在基线和12个月时收集临床和磁共振成像（MRI）数据。主要结局是12个月时达到无疾病活动证据（NEDA）的患者比例。次要结局包括年化复发率和MRI活动情况。
共纳入223例患者（NTZ组109例，FTY组114例）。治疗组在基线时均衡良好。NTZ组NEDA患者比例为47.8%，FTY组为30.4%（P = 0.015）。这种优势由年化复发率和MRI活动情况驱动。在多变量分析中，治疗组是与12个月时NEDA相关的唯一因素，FTY组概率较低（比值比（OR）= 0.49，P = 0.029）。
BEST-MS是一项前瞻性研究，直接比较了NTZ和FTY在活动性复发缓解型MS中的疗效。我们的结果表明NTZ优于FTY。
