Dobson Ruth, Arun Tarunya, Varley James, Chataway Jeremy, Brownlee Wallace, Gallagher Paul, Giovannoni Gavin, Gray Orla, Ingram Gillian, MacDougall Niall, Muraro Paolo A, Murray Katy, Paling David, Petheram Kate, Rashid Waqar, Tallantyre Emma, Trip S Anand, Coles Alasdair
Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, UK; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, UK.
Department of Neurology, University Hospital Coventry and Warwickshire, UK; University of Warwick, UK.
Mult Scler Relat Disord. 2025 Aug;100:106541. doi: 10.1016/j.msard.2025.106541. Epub 2025 May 22.
Biosimilars have an important role to play in healthcare, with the potential to reduce costs and widen access to treatment. We welcome the use of biosimilars in the treatment of multiple sclerosis. Serological testing for JC virus is mandated as part of safety monitoring in those treated with natalizumab. All PML risk stratification data to date has come from the use of the "Stratify" JC virus (JCV) serostatus test. The "Immunowell" test used to define JCV serostatus (used with Tyruko) does not always give equivalent results to the Stratify test (used with Tysabri), particularly around thresholds used to define risk of progressive multifocal leukoencephalopathy (PML). In comparison to the Stratify test, Immunowell appears more likely to report a positive JCV index. However, negative results using Immunowell show a high rate of agreement with Stratify, which allows for a rational safety strategy. There remains a real risk that a proportion of patients will be inappropriately classified as being at higher risk of PML, and therefore denied the option of natalizumab, a highly effective therapy, or undergo unnecessarily burdensome monitoring, with resultant cost to the NHS and anxiety. We provide guidance for patients with discordant results between assays, aiming to balance the need for rigorous safety monitoring with patient access to highly effective therapy and unnecessary monitoring burden on healthcare services.
生物类似药在医疗保健中发挥着重要作用，具有降低成本和扩大治疗可及性的潜力。我们欢迎使用生物类似药治疗多发性硬化症。对于接受那他珠单抗治疗的患者，JC病毒血清学检测是安全监测的一部分。迄今为止，所有进行进行性多灶性白质脑病（PML）风险分层的数据均来自使用“Stratify”JC病毒（JCV）血清状态检测。用于定义JCV血清状态的“Immunowell”检测（与Tyruko一起使用）与Stratify检测（与Tysabri一起使用）的结果并不总是一致，尤其是在用于定义进行性多灶性白质脑病（PML）风险的阈值附近。与Stratify检测相比，Immunowell似乎更有可能报告JCV指数呈阳性。然而，Immunowell检测的阴性结果与Stratify检测的结果高度一致，这使得可以制定合理的安全策略。仍然存在一个实际风险，即一部分患者会被不恰当地归类为PML风险较高，因此被剥夺使用那他珠单抗（一种高效疗法）的选择，或者接受不必要的繁重监测，给英国国家医疗服务体系（NHS）带来成本并造成患者焦虑。我们为检测结果不一致的患者提供指导，旨在平衡严格安全监测的需求与患者获得高效治疗的机会以及医疗服务不必要的监测负担之间的关系。
