从Natalizumab切换到Alemtuzumab的患者病程：一项意大利多中心、前瞻性观察研究
IF 3.9
3区 医学
Q1 CLINICAL NEUROLOGY
引用次数: 0
摘要
Natalizumab是一种治疗复发缓解型多发性硬化症（RRMS）的高效疗法（HET）。抗jcv抗体阳性的患者发生进行性多灶性白质脑病（PML）的风险限制了其长期使用。这项工作的目的是评估阿仑单抗输注后6个月和12个月的临床和放射学疗效，以及这种退出策略的安全性。方法：这项现实世界、前瞻性、多中心、观察性研究在三个意大利多发性硬化症中心进行，共纳入35例RRMS患者。Natalizumab的治疗时间为2010年10月至2021年4月，而改用阿仑单抗的时间为2018年2月至2023年1月。两种药物的中位洗脱期为2个月。患者在阿仑妥珠单抗开始前以及第一个阿仑妥珠单抗周期后的6个月和12个月分别接受脑MRI检查。结果：洗脱期、第一次和第二次阿仑单抗输注期间均未发生临床复发。在首次阿仑单抗给药后6个月和12个月，分别有4/35（11%）和2/35（6%）患者出现放射活性。在6个月和12个月时，4/35（11%）和5/35（14%）患者的扩展残疾状态量表（EDSS）增加。无PML发生，无严重不良事件发生。对于中心1的患者（17例），随访时间中位数为3.5年；随访结束时，14/17例（82%）患者出现NEDA-3（无疾病活动证据）。23%的患者发生自身免疫。结论：Alemtuzumab是natalizumab中断后有效的退出策略。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Disease Course in Patients Switched from Natalizumab to Alemtuzumab: An Italian Multicenter, Prospective, Observational Study.
Introduction: Natalizumab is a highly efficacious therapy (HET) for patients with relapsing remitting multiple sclerosis (RRMS). Its prolonged use is limited by the risk of progressive multifocal leukoencephalopathy (PML) in patients positive for anti-JCV antibodies. Aims of this work were to evaluate clinical and radiological efficacy at 6 and 12 months after alemtuzumab infusion in patients switching from natalizumab and the safety of this exit strategy.
Methods: This real-world, prospective, multicentric, observational study was conducted in three Italian MS centers and included a total of 35 patients with RRMS. Natalizumab treatment occurred from October 2010 to April 2021, whereas switch to alemtuzumab occurred from February 2018 to January 2023. Median washout period between the two drugs was 2 months. Patients underwent brain MRI before alemtuzumab start and then 6 and 12 months after the first alemtuzumab cycle.
Results: No clinical relapse occurred during the washout period, nor between the first and second alemtuzumab infusion. Radiological activity was present in 4/35 (11%) and 2/35 (6%) patients, respectively, at 6 and 12 months after the first alemtuzumab administration. Expanded Disability Status Scale (EDSS) increase developed in 4/35 (11%) and 5/35 patients (14%), respectively, at 6 and 12 months. No PML occurred, nor any serious adverse event. For patients in center 1 (17 patients), follow-up continued for a median of 3.5 years; NEDA-3 (No Evidence of Disease Activity) was present in 14/17 patients (82%) at the end of follow-up. Autoimmunity occurred in 23% of patients.
Conclusions: Alemtuzumab is a valid exit strategy after natalizumab interruption.
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来源期刊
Neurology and Therapy
CLINICAL NEUROLOGY-
CiteScore
5.40
自引率
8.10%
发文量
103
审稿时长
6 weeks
期刊介绍：
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