估算英国对阿尔茨海默病潜在疾病改变疗法的需求。

IF 8.7 1区 医学 Q1 PSYCHIATRY British Journal of Psychiatry Pub Date : 2024-06-01 DOI:10.1192/bjp.2023.166
Axel A S Laurell, Ashwin V Venkataraman, Tatjana Schmidt, Marcella Montagnese, Christoph Mueller, Robert Stewart, Jonathan Lewis, Clare Mundell, Jeremy D Isaacs, Mani S Krishnan, Robert Barber, Timothy Rittman, Benjamin R Underwood
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引用次数: 0

摘要

背景:针对脑淀粉样蛋白的单克隆抗体莱卡奈单抗(lecanemab)和多那奈单抗(donanemab)的三期试验报告显示,这两种单克隆抗体在早期阿尔茨海默病的临床终点方面存在统计学意义上的显著差异。这些药物已在一些国家使用,并正在通过在英国使用的监管审批程序。考虑到管理和监测所需的资源,人们对包括英国在内的医疗系统提供这些治疗的能力表示担忧:我们使用两家国民健康服务托管机构 2019 年的匿名患者记录数据库,收集这些队列的临床、人口统计学、认知和神经影像学数据。治疗资格根据多那单抗和来卡尼单抗临床试验的纳入标准进行评估,并考虑了诊断、认知表现、脑血管疾病和接受治疗的意愿:我们检查了 82 386 名转诊患者的病历,覆盖人群约 220 万。在应用试验标准后,我们估计每年最多有 906 人将在这两家服务机构开始接受单克隆抗体治疗,如果推算到全国,则相当于 30 200 人:单克隆抗体治疗阿尔茨海默病可能会在神经影像学和治疗提供方面给医疗服务带来巨大挑战。本文提供的数据可帮助医疗服务机构了解潜在需求并制定相应计划。
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Estimating demand for potential disease-modifying therapies for Alzheimer's disease in the UK.

Background: Phase three trials of the monoclonal antibodies lecanemab and donanemab, which target brain amyloid, have reported statistically significant differences in clinical end-points in early Alzheimer's disease. These drugs are already in use in some countries and are going through the regulatory approval process for use in the UK. Concerns have been raised about the ability of healthcare systems, including those in the UK, to deliver these treatments, considering the resources required for their administration and monitoring.

Aims: To estimate the scale of real-world demand for monoclonal antibodies for Alzheimer's disease in the UK.

Method: We used anonymised patient record databases from two National Health Service trusts for the year 2019 to collect clinical, demographic, cognitive and neuroimaging data for these cohorts. Eligibility for treatment was assessed using the inclusion criteria from the clinical trials of donanemab and lecanemab, with consideration given to diagnosis, cognitive performance, cerebrovascular disease and willingness to receive treatment.

Results: We examined the records of 82 386 people referred to services covering around 2.2 million people. After applying the trial criteria, we estimate that a maximum of 906 people per year would start treatment with monoclonal antibodies in the two services, equating to 30 200 people if extrapolated nationally.

Conclusions: Monoclonal antibody treatments for Alzheimer's disease are likely to present a significant challenge for healthcare services to deliver in terms of the neuroimaging and treatment delivery. The data provided here allows health services to understand the potential demand and plan accordingly.

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来源期刊
British Journal of Psychiatry
British Journal of Psychiatry 医学-精神病学
CiteScore
13.70
自引率
1.90%
发文量
184
审稿时长
4-8 weeks
期刊介绍: The British Journal of Psychiatry (BJPsych) is a renowned international journal that undergoes rigorous peer review. It covers various branches of psychiatry, with a specific focus on the clinical aspects of each topic. Published monthly by the Royal College of Psychiatrists, this journal is dedicated to enhancing the prevention, investigation, diagnosis, treatment, and care of mental illness worldwide. It also strives to promote global mental health. In addition to featuring authoritative original research articles from across the globe, the journal includes editorials, review articles, commentaries on contentious issues, a comprehensive book review section, and a dynamic correspondence column. BJPsych is an essential source of information for psychiatrists, clinical psychologists, and other professionals interested in mental health.
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