一项关于那他珠单抗在印度多发性硬化症患者中的疗效和安全性的真实世界多中心研究。
A real world multi center study on efficacy and safety of natalizumab in Indian patients with multiple sclerosis.
机构信息
Department of Neurology, St. John's Medical College Hospital, Sarjapura Road, Bengaluru, Karnataka 560034, India.
Department of Neurology, Trustwell Hospitals, Chandrika tower 5 JC Road Sudama Nagar, Bengaluru, Karnataka 560002, India.
出版信息
Mult Scler Relat Disord. 2022 Oct;66:104059. doi: 10.1016/j.msard.2022.104059. Epub 2022 Jul 25.
BACKGROUND
Natalizumab (NTZ) is increasingly being used in Indian multiple sclerosis (MS) patients. There are no reports on its safety and efficacy, especially with respect to the occurrence of progressive multifocal leukoencephalopathy (PML).
OBJECTIVES
To describe the patient characteristics, treatment outcomes, and adverse events, especially the occurrence of PML in NTZ-treated patients.
METHODS
A multicentre ambispective study was conducted across 18 centres, from Jan 2012 to Dec 2021. Patients at and above the age of 18 years treated with NTZ were included. Descriptive and comparative statistics were applied to analyze data.
RESULTS
During the study period of 9 years, 116 patients were treated with NTZ. Mean age of the cohort was 35.6 ± 9.7 years; 83/116 (71.6%) were females. Relapse rate for the entire cohort in the year before NTZ was 3.1 ± 1.51 while one year after was 0.20±0.57 (p = 0.001; CI 2.45 -3.35). EDSS of the entire cohort in the year before NTZ was 4.5 ± 1.94 and one year after was 3.8 ± 2.7 (p = 0.013; CI 0.16-1.36). At last follow up (38.3 ± 22.78 months) there were no cases of PML identified.
CONCLUSIONS
Natalizumab is highly effective and safe in Indian MS patients, with no cases of PML identified at last follow up.
背景
那他珠单抗（NTZ）在印度多发性硬化症（MS）患者中的应用日益增多。目前尚无关于其安全性和疗效的报告，特别是关于进行性多灶性白质脑病（PML）的发生情况。
目的
描述 NTZ 治疗患者的患者特征、治疗结局和不良事件，特别是 PML 的发生情况。
方法
这是一项跨 18 个中心的多中心前瞻性研究，从 2012 年 1 月至 2021 年 12 月进行。纳入了接受 NTZ 治疗的年龄在 18 岁及以上的患者。采用描述性和对比性统计分析数据。
结果
在 9 年的研究期间，共有 116 名患者接受了 NTZ 治疗。队列的平均年龄为 35.6±9.7 岁；83/116（71.6%）为女性。整个队列在接受 NTZ 治疗前一年的复发率为 3.1±1.51，而治疗后一年为 0.20±0.57（p=0.001；CI 2.45-3.35）。整个队列在接受 NTZ 治疗前一年的 EDSS 为 4.5±1.94，治疗后一年为 3.8±2.7（p=0.013；CI 0.16-1.36）。最后一次随访（38.3±22.78 个月）时未发现 PML 病例。
结论
那他珠单抗在印度 MS 患者中疗效显著且安全，最后一次随访时未发现 PML 病例。
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