Rath Louise, Vijiaratnam Nirosen, Skibina Olga
Neurology Department, Alfred Health, Melbourne, Victoria, Australia.
Intern Med J. 2017 Feb;47(2):194-199. doi: 10.1111/imj.13318.
Natalizumab, a monoclonal antibody directed against α4 integrin, is a highly efficacious treatment commonly used in relapsing remitting multiple sclerosis. Natalizumab is associated with the potentially fatal, rare, demyelinating, opportunistic brain infection, progressive multifocal leukoencephalopathy (PML). Prognosis and disability from PML are determined by early diagnosis.
Written tools are mandated in Australia and other prescribing countries with the aim to help patients understand the risks associated with treatment and ensure familiarity with the early symptoms of PML. We aimed to assess if these tools achieve such an outcome.
A cross-sectional survey was conducted using a convenience sample of multiple sclerosis patients prescribed natalizumab presenting to the infusion centre at a major tertiary hospital. Patients were offered a multi-choice questionnaire to assess their knowledge on the treatment risks and surveillance requirements of their therapy. Three specific questions were highlighted by the researchers as crucial to patient understanding of PML and defined as basic knowledge.
A total of 48 patients in our hospital was prescribed natalizumab; 37 responded. A total of 16 (43.2%) patients answered all three basic knowledge questions correctly. There was no difference in the ability to answer these questions based on length of treatment or co-ownership knowledge between patients with base knowledge and without.
Natalizumab is associated with an increased risk of PML. Early detection and treatment of PML results in improved patient outcomes. Patient knowledge and co-partnership in the utilisation of PML risk tools is relevant in ensuring early detection. Our findings question the ability of currently sanctioned tools to inform patients of basic knowledge of PML and their risk of developing PML. A future study with a repetitive education approach and repeating the questionnaire at multiple time points would be of interest.
那他珠单抗是一种针对α4整合素的单克隆抗体，是复发缓解型多发性硬化症常用的高效治疗药物。那他珠单抗与潜在致命、罕见的脱髓鞘机会性脑部感染——进行性多灶性白质脑病（PML）有关。PML的预后和残疾情况取决于早期诊断。
澳大利亚和其他处方用药国家要求使用书面工具，以帮助患者了解治疗相关风险，并确保其熟悉PML的早期症状。我们旨在评估这些工具是否能达到这一效果。
采用横断面调查，对一家大型三级医院输液中心接受那他珠单抗治疗的多发性硬化症患者进行便利抽样。向患者提供一份多项选择题问卷，以评估他们对治疗风险和监测要求的了解情况。研究人员强调了三个特定问题对患者理解PML至关重要，并将其定义为基本知识。
我院共有48例患者使用那他珠单抗；37例做出回应。共有16例（43.2%）患者正确回答了所有三个基本知识问题。基于治疗时长或是否有基本知识，患者回答这些问题的能力没有差异。
那他珠单抗与PML风险增加有关。PML的早期检测和治疗可改善患者预后。患者对PML风险工具的了解及共同参与对于确保早期检测至关重要。我们的研究结果对目前批准使用的工具能否让患者了解PML基本知识及其患PML风险提出了质疑。未来采用重复教育方法并在多个时间点重复问卷调查的研究将很有意义。
