背景:纳他珠单抗治疗在临床试验中非常有效,在复发缓解型多发性硬化症患者的临床实践中非常有效,通过减少复发,减缓疾病进展,并改善磁共振成像模式。然而,该药物还与进行性多灶性白质脑病(PML)的风险相关.关于纳他珠单抗使用的第一个共识声明,2011年出版,已更新为包括诊断程序的新数据,监测正在接受治疗的患者,PML管理,以及其他感兴趣的主题,包括停用那他珠单抗的患者的管理。
方法:此更新版本遵循了第一个共识中使用的方法。一组西班牙多发性硬化症专家(本文件的作者)审查了所有现有的关于那他珠单抗的文献,并根据他们的临床经验确定了相关主题需要更新。初稿通过了审查周期,直到最终版本完成。
结论:临床实践中的研究表明,改用那他珠单抗比在免疫调节剂之间切换更有效。他们倾向于早期使用那他珠单抗治疗,而不是在后期使用那他珠单抗作为抢救治疗。虽然这种药非常有效,其潜在的不利影响需要考虑,特别注意患者发展为PML的可能性。神经科医生应仔细解释治疗的风险和益处,将它们与患者可以理解的多发性硬化症的风险进行比较。治疗开始前,应提供实验室测试和磁共振图像,以进行适当的随访。PML的风险应该分层为高,中等,或低根据是否存在抗JC病毒抗体,免疫抑制治疗史,和治疗持续时间。尽管抗JC病毒抗体的存在是一个重要的发现,不应将其视为那他珠单抗的绝对禁忌症.此更新提供了一般性建议,但神经科医师必须利用他们的临床专业知识为每位患者提供个性化的随访。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.