Servicio de Neurología, Hospital Povisa, Vigo, Spain.
Servicio de Neurología, Hospital Clínico Universitario Santiago de Compostela, Santiago de Compostela, Spain.
Neurologia (Engl Ed). 2021 Jun;36(5):346-352. doi: 10.1016/j.nrleng.2020.02.001. Epub 2020 Feb 16.
The safety and effectiveness of natalizumab in patients with relapsing-remitting multiple sclerosis (RRMS) has been demonstrated in clinical trials. However, due to the limitations of these trials, it is important to know how the condition behaves under long-term clinical practice conditions.
To determine the long-term effectiveness of natalizumab in patients with RRMS by means of annual evaluation of the "no evidence of disease activity" (NEDA) parameter, which includes number of relapses, disability (measured with the Expanded Disability Status Scale), and brain MRI parameters.
We performed a retrospective study of patients with RRMS from 3 centres who were treated with one or more doses of natalizumab. Each year, we evaluated NEDA status and safety based on the percentage of patients who discontinued treatment with natalizumab and experienced adverse reactions.
The study included 89 patients, most of whom received treatment for 2 to 4 years, with a follow-up period of up to 7 years. Natalizumab significantly reduces the radiological and clinical progression of the disease, as well as the annual rate of relapses. The NEDA parameter demonstrates the effectiveness of the drug, with values of 75.28% for year one and 66.67% for year 7. Twenty-five patients (28.1%) dropped out after a median of 4 years. Fourteen of these patients (56%) dropped out due to the appearance of anti-JC virus antibodies, either in isolation or associated with another cause. Four dropouts (16%) were due to treatment ineffectiveness, with one patient dying due to progressive multifocal leukoencephalopathy.
Natalizumab is highly effective as measured by the NEDA long-term remission parameter.
纳武利尤单抗在复发缓解型多发性硬化症（RRMS）患者中的安全性和有效性已在临床试验中得到证实。然而，由于这些试验的局限性，了解该疾病在长期临床实践条件下的表现非常重要。
通过每年评估“无疾病活动”（NEDA）参数来确定纳武利尤单抗在 RRMS 患者中的长期疗效，该参数包括复发次数、残疾（采用扩展残疾状况量表测量）和脑 MRI 参数。
我们对来自 3 个中心的接受过一次或多次纳武利尤单抗治疗的 RRMS 患者进行了回顾性研究。每年，我们根据停止纳武利尤单抗治疗和发生不良反应的患者比例来评估 NEDA 状态和安全性。
该研究纳入了 89 例患者，其中大多数患者接受治疗 2 至 4 年，随访时间长达 7 年。纳武利尤单抗显著降低疾病的影像学和临床进展以及年复发率。NEDA 参数表明药物有效，第 1 年的数值为 75.28%，第 7 年为 66.67%。中位数为 4 年后有 25 例患者（28.1%）停药。其中 14 例（56%）因出现抗 JC 病毒抗体而停药，要么单独出现，要么与其他原因相关。4 例停药（16%）是由于治疗无效，其中 1 例因进行性多灶性白质脑病死亡。
纳武利尤单抗在 NEDA 长期缓解参数方面具有高度疗效。
