Fernández O, García-Merino J A, Arroyo R, Álvarez-Cermeño J C, Izquierdo G, Saiz A, Olascoaga J, Rodríguez-Antigüedad A, Prieto J M, Oreja-Guevara C, Hernández M A, Moral E, Meca J, Montalbán X
Instituto de Neurociencias Clínicas, Servicio de Neurología, Hospital Regional Universitario Carlos Haya, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Málaga, España.
Servicio de Neurología, Hospital Universitario Puerta de Hierro, Madrid, España.
Neurologia. 2015 Jun;30(5):302-14. doi: 10.1016/j.nrl.2013.10.004. Epub 2013 Dec 19.
Natalizumab treatment has been shown to be very efficacious in clinical trials and very effective in clinical practice in patients with relapsing-remitting multiple sclerosis, by reducing relapses, slowing disease progression, and improving magnetic resonance imaging patterns. However, the drug has also been associated with a risk of progressive multifocal leukoencephalopathy (PML). The first consensus statement on natalizumab use, published in 2011, has been updated to include new data on diagnostic procedures, monitoring for patients undergoing treatment, PML management, and other topics of interest including the management of patients discontinuing natalizumab.
This updated version followed the method used in the first consensus. A group of Spanish experts in multiple sclerosis (the authors of the present document) reviewed all currently available literature on natalizumab and identified the relevant topics would need updating based on their clinical experience. The initial draft passed through review cycles until the final version was completed.
Studies in clinical practice have demonstrated that changing to natalizumab is more effective than switching between immunomodulators. They favour early treatment with natalizumab rather than using natalizumab in a later stage as a rescue therapy. Although the drug is very effective, its potential adverse effects need to be considered, with particular attention to the patient's likelihood of developing PML. The neurologist should carefully explain the risks and benefits of the treatment, comparing them to the risks of multiple sclerosis in terms the patient can understand. Before treatment is started, laboratory tests and magnetic resonance images should be available to permit proper follow-up. The risk of PML should be stratified as high, medium, or low according to presence or absence of anti-JC virus antibodies, history of immunosuppressive therapy, and treatment duration. Although the presence of anti-JC virus antibodies is a significant finding, it should not be considered an absolute contraindication for natalizumab. This update provides general recommendations, but neurologists must use their clinical expertise to provide personalised follow-up for each patient.
在复发缓解型多发性硬化症患者的临床试验和临床实践中，那他珠单抗治疗已显示出非常显著的疗效，能够减少复发、减缓疾病进展并改善磁共振成像表现。然而，该药物也与进行性多灶性白质脑病（PML）风险相关。2011年发表的关于那他珠单抗使用的首份共识声明已更新，纳入了有关诊断程序、治疗中患者监测、PML管理以及其他相关主题（包括停用那他珠单抗患者的管理）的新数据。
本次更新版本遵循首份共识所采用的方法。一组西班牙多发性硬化症专家（本文作者）查阅了所有当前可得的关于那他珠单抗的文献，并根据他们的临床经验确定了需要更新的相关主题。初稿经过多轮审核直至最终版本完成。
临床实践研究表明，换用那他珠单抗比在免疫调节剂之间切换更有效。他们支持早期使用那他珠单抗治疗，而非在后期将其作为挽救疗法使用。尽管该药物非常有效，但需要考虑其潜在的不良反应，尤其要关注患者发生PML的可能性。神经科医生应仔细向患者解释治疗的风险和益处，并以患者能够理解的方式将其与多发性硬化症的风险进行比较。在开始治疗前，应具备实验室检查结果和磁共振图像以便进行适当的随访。应根据是否存在抗JC病毒抗体、免疫抑制治疗史和治疗持续时间，将PML风险分层为高、中或低。尽管存在抗JC病毒抗体是一个重要发现，但不应将其视为那他珠单抗的绝对禁忌证。本更新提供了一般性建议，但神经科医生必须运用其临床专业知识为每位患者提供个性化随访。
