■利妥昔单抗(RTX)是一种抗CD20单克隆抗体,用于治疗癌症中的各种疾病,类风湿性关节炎(RA),和多发性硬化症(MS)。尽管RTX在美国已经使用了近30年,关于其在现实世界中的利用率和有效性的问题仍然存在。
■为了描述观察性研究和真实世界证据评估RTX在肿瘤学中的状况,RA,和MS中的标签外使用
■在MEDLINE进行了广泛的搜索,Embase,和CINAHL涵盖2010年1月至2022年6月期间。两名评审员独立筛选了每个疾病类别(癌症,RA,MS)从标题评论开始,其次是抽象,和全文审查,以确定最终要包括的相关出版物。根据总体趋势提取和总结每种疾病的数据,相似性,以及纳入研究之间的差异,并按疾病状态分层。
■共有260项研究符合资格标准,RA队列有79项研究,144癌症,37女士在所有疾病队列中,大多数研究(n=189;72.7%)为回顾性研究.171(65.8%)研究使用医院或电子健康记录数据作为数据源,65(23.2%)使用注册数据库。大多数研究(n=153;58.8%)通过疾病特异性终点评估RTX的有效性,其次是安全性(n=60;23.1%),治疗模式(n=32;12.3%),和评估治疗依从性和疾病经济负担的描述性分析(n=16;6.2%)。虽然安全性不是大多数研究的主要结果,所有疾病状态的大多数研究仍报告了某种形式的安全措施.关于RTX的益处的结论性陈述因疾病状态而异,MS最多(n=30;81.1%)的研究表明该药物的积极益处。评估RTX使用的研究有限,相关的经济负担,和生物相似物转换。
■这些发现强调了医疗保健提供者需要更好地了解RTX的治疗前景和利用情况,特别是在患者选择方面,启动时间,和长期结果。现实世界的证据可以帮助支持使用利妥昔单抗的医疗保健决策和治疗。
UNASSIGNED: Rituximab (RTX) is an anti-CD20 monoclonal antibody that is used to treat various conditions in cancer, rheumatoid arthritis (RA), and multiple sclerosis (MS). Although RTX has been used in the United States for almost 3 decades, questions remain regarding its real-world utilization and effectiveness.
UNASSIGNED: To describe the state of observational research and real-world evidence evaluating RTX in oncology, RA, and off-label use in MS.
UNASSIGNED: A broad search was conducted in MEDLINE, Embase, and CINAHL covering the period of January 2010 to June 2022. Two reviewers independently screened all identified records for each disease category (cancer, RA, MS) beginning with title
review, followed by abstract, and full-text
review to identify relevant publications to include in the final analysis. Data were extracted and summarized for each disease based on overall trends, similarities, and differences across included studies and stratified by disease state.
UNASSIGNED: A total of 260 studies met eligibility criteria, with 79 studies for the RA cohort, 144 for cancer, and 37 for MS. Across all disease cohorts, most studies (n = 189; 72.7%) were retrospective. 171 (65.8%) studies used hospital or electronic health record data as their data source and 65 (23.2%) used registry databases. Most studies (n = 153; 58.8%) assessed the effectiveness of RTX measured by disease-specific endpoints, followed by safety (n = 60; 23.1%), treatment patterns (n = 32; 12.3%), and descriptive analyses assessing treatment adherence and economic burden of disease (n = 16; 6.2%). Although safety was not the primary outcome for most studies, the majority of studies across all disease states still reported some form of safety measure. Conclusive statements on RTX\'s benefit varied across disease states, with MS having the most (n = 30; 81.1%) studies suggesting the drug\'s positive benefit. There were limited studies assessing RTX use, associated economic burden, and biosimilar switching.
UNASSIGNED: The findings underscore the need for health care providers to better understand the treatment landscape and utilization of RTX, particularly in terms of patient selection, timing of initiation, and long-term outcomes. Real-world evidence can help support health care decisions and treatment using rituximab.