在一个分布式研究网络中,贝伐单抗在眼科和肿瘤学中的患者特征和使用。

IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Jenice S Ko, Aaron B Mendelsohn, Kimberly Daniels, Ainhoa Gomez-Lumbreras, James Marshall, Cara McDermott, Pamala A Pawloski, Gary C Yee, Catherine M Lockhart
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引用次数: 0

摘要

背景:尽管贝伐单抗及其生物类似药被广泛使用,但贝伐单抗在美国的实际使用数据有限,特别是贝伐单抗生物类似药用于眼科疾病。目的:评估贝伐单抗的使用模式和患者特征,相对于其生物仿制药,用于标签和非标签肿瘤和眼科疾病,并描述使用贝伐单抗治疗肿瘤适应症患者的不良事件。方法:我们在生物制剂和生物类似药集体情报联盟分布式数据库中进行了一项回顾性队列研究,以确定2010年1月1日至2021年6月30日期间接受贝伐单抗治疗的21岁及以上患者。肿瘤适应症包括结肠癌、肺癌和妇科(子宫颈癌、子宫癌和卵巢癌)。眼科适应症包括新生血管性年龄相关性黄斑变性(AMD)、视网膜静脉闭塞(RVO)、脉络膜新生血管(CNV)和增殖性糖尿病视网膜病变(PDR)。我们还捕获了患者的人口统计学和临床特征。结果:从2015年开始,贝伐单抗产品(原药和生物仿制药)的总使用量随着RVO、CNV和PDR的使用而增加,但在2016年之后AMD的使用减少。对于眼科,贝伐单抗产品使用者主要是男性(56.8%),平均年龄为62.9岁(SD = 0.08), Charlson/Elixhauser的平均合病评分从0.7 (CNV)到2.7 (PDR)不等。贝伐单抗用于肿瘤适应症的患者主要是女性(61.8%),平均年龄为62.9岁(SD = 12.2), Charlson/Elixhauser的平均合病评分为7.4 (SD = 3.0)。在2019年至2020年期间,肿瘤生物类似药的使用随着时间的推移增加如下:结肠癌,从6.2%增加到49.4%;肺癌,1.9%至36.2%;妇科癌症,从2.4%到38.1%。结论:在研究期间,贝伐单抗产品的使用在大多数适应症中都有所增加。一旦上市,生物仿制药的使用在随后几年相对于原研药增加。在美国,生物仿制药的实际使用数据有限;未来的研究应包括监测这些产品的使用和不良事件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Patient characteristics and use for bevacizumab in ophthalmology and oncology in a distributed research network.

Background: Although bevacizumab and its biosimilars are commonly used, there are limited real-world data on bevacizumab use in the United States, especially biosimilar bevacizumab used in ophthalmologic conditions.

Objective: To evaluate use patterns and patient characteristics for the originator bevacizumab relative to its biosimilars for labeled and off-label oncology and ophthalmology conditions and characterize adverse events in patients using bevacizumab for oncologic indications.

Methods: We conducted a retrospective cohort study with the Biologics and Biosimilars Collective Intelligence Consortium-distributed database to identify patients aged 21 years and older who received bevacizumab between January 1, 2010, and June 30, 2021. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Ophthalmologic indications included neovascular age-related macular degeneration (AMD), retinal vein occlusion (RVO), choroidal neovascularization (CNV), and proliferative diabetic retinopathy (PDR). We also captured patients' demographic and clinical characteristics.

Results: Total bevacizumab product (originator and biosimilars) use increased over time for RVO, CNV, and PDR starting in 2015 but decreased for AMD after 2016. For ophthalmology, bevacizumab product users were primarily male (56.8%), had a mean age of 62.9 years (SD = 0.08), and had a mean Charlson/Elixhauser combined comorbidity score ranging from 0.7 (CNV) to 2.7 (PDR). Bevacizumab users for oncology indications were mostly female (61.8%), had a mean age of 62.9 years (SD = 12.2), and had a mean Charlson/Elixhauser combined comorbidity score of 7.4 (SD = 3.0). Oncologic biosimilar product use increased over time between 2019 and 2020 as follows: colon cancer, 6.2% to 49.4%; lung cancer, 1.9% to 36.2%; and gynecologic cancer, 2.4% to 38.1%.

Conclusions: Bevacizumab product use increased across most indications during the study period. Use for biosimilars increased in later years relative to the originator once available on the market. Limited data are available on real-world biosimilar use in the United States; future research should include monitoring for use and adverse events of these products.

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来源期刊
Journal of managed care & specialty pharmacy
Journal of managed care & specialty pharmacy Health Professions-Pharmacy
CiteScore
3.50
自引率
4.80%
发文量
131
期刊介绍: JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.
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