利妥昔单抗治疗多发性硬化症：意大利 - 瑞士多中心经验。
Treatment of multiple sclerosis with rituximab: A multicentric Italian-Swiss experience.
作者信息
Zecca Chiara, Bovis Francesca, Novi Giovanni, Capobianco Marco, Lanzillo Roberta, Frau Jessica, Repice Anna Maria, Hakiki Bahia, Realmuto Sabrina, Bonavita Simona, Curti Erica, Brambilla Laura, Mataluni Giorgia, Cavalla Paola, Di Sapio Alessia, Signoriello Elisabetta, Barone Stefania, Maniscalco Giorgia T, Maietta Ilaria, Maraffi Isabella, Boffa Giacomo, Malucchi Simona, Nozzolillo Agostino, Coghe Giancarlo, Mechi Claudia, Salemi Giuseppe, Gallo Antonio, Sacco Rosaria, Cellerino Maria, Malentacchi Maria, De Angelis Marcello, Lorefice Lorena, Magnani Eliana, Prestipino Elio, Sperli Francesca, Brescia Morra Vincenzo, Fenu Giuseppe, Barilaro Alessandro, Abbadessa Gianmarco, Signori Alessio, Granella Franco, Amato Maria Pia, Uccelli Antonio, Gobbi Claudio, Sormani Maria Pia
机构信息
Neurocentre of Southern Switzerland, Department of Neurology, Ospedale Civico, Lugano, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.
Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
出版信息
Mult Scler. 2020 Oct;26(12):1519-1531. doi: 10.1177/1352458519872889. Epub 2019 Oct 1.
BACKGROUND
Rituximab, an anti-CD20 monoclonal antibody leading to B lymphocyte depletion, is increasingly used as an off-label treatment option for multiple sclerosis (MS).
OBJECTIVE
To investigate the effectiveness and safety of rituximab in relapsing-remitting (RR) and progressive MS.
METHODS
This is a multicenter, retrospective study on consecutive MS patients treated off-label with rituximab in 22 Italian and 1 Swiss MS centers. Relapse rate, time to first relapse, Expanded Disability Status Scale (EDSS) progression, incidence of adverse events, and radiological outcomes from 2009 to 2019 were analyzed.
RESULTS
A total of 355/451 enrolled subjects had at least one follow-up visit and were included in the outcome analysis. Annualized relapse rate significantly decreases after rituximab initiation versus the pre-rituximab start year in RRMS (from 0.86 to 0.09, < .0001) and in secondary-progressive (SP) MS (from 0.34 to 0.06, < .0001) and had a slight decrease in primary-progressive (PP) MS patients (from 0.12 to 0.07, = 0.45). After 3 years from rituximab start, the proportion of patients with a confirmed EDSS progression was 14.6% in the RRMS group, 24.7% in the SPMS group, and 41.5% in the PPMS group. No major safety concerns arose.
CONCLUSION
Consistently with other observational studies, our data show effectiveness of rituximab in reducing disease activity in patients with MS.
背景
利妥昔单抗是一种可导致B淋巴细胞耗竭的抗CD20单克隆抗体，越来越多地被用作治疗多发性硬化症（MS）的一种非标签治疗选择。
目的
研究利妥昔单抗治疗复发缓解型（RR）和进展型MS的有效性和安全性。
方法
这是一项在22个意大利和1个瑞士MS中心对接受利妥昔单抗非标签治疗的连续性MS患者进行的多中心回顾性研究。分析了2009年至2019年的复发率、首次复发时间、扩展残疾状态量表（EDSS）进展、不良事件发生率和影像学结果。
结果
共有355/451名入组受试者至少进行了一次随访，并纳入了结果分析。与使用利妥昔单抗前的起始年份相比，RRMS患者在开始使用利妥昔单抗后年化复发率显著降低（从0.86降至0.09，<0.0001），继发进展型（SP）MS患者也显著降低（从0.34降至0.06，<0.0001），原发进展型（PP）MS患者略有下降（从0.12降至0.07，=0.45）。在开始使用利妥昔单抗3年后，RRMS组确诊EDSS进展的患者比例为14.6%，SPMS组为24.7%，PPMS组为41.5%。未出现重大安全问题。
结论
与其他观察性研究一致，我们的数据表明利妥昔单抗在降低MS患者疾病活动度方面有效。
Zotero 插件