Department of Medicine, Stanford University, Stanford, CA.
Partnership for Health Analytics, LLC, Beverly Hills, CA.
J Manag Care Spec Pharm. 2021 Dec;27(12):1724-1733. doi: 10.18553/jmcp.2021.27.12.1724.
Additional real-world studies are needed to more fully elucidate the effectiveness of antifibrotic treatment in slowing the progression of idiopathic pulmonary fibrosis (IPF). To compare mortality and hospitalization between Medicare beneficiaries with IPF who initiate antifibrotic therapy and those who did not receive treatment. A retrospective observational study of Medicare beneficiaries using the 100% Medicare Research Identifiable File was conducted. We included patients aged 67 years and over diagnosed with IPF (≥ 1 inpatient or ≥ 2 outpatient claims with IPF diagnosis) during the study period (January 1, 2010-December 31, 2017). Patients who initiated antifibrotic treatment (pirfenidone or nintedanib) between October 15, 2014 (FDA approval date) and December 31, 2017 (ie, treated patients) were compared with those who did not receive treatment during a historical period (January 1, 2012-October 14, 2014) before the availability of antifibrotics (ie, untreated historical controls). Patients were matched by propensity score, and the outcomes, mortality, and hospitalization (all cause and respiratory related) were compared using a Cox proportional hazards model. We identified 4,641 treated patients and 4,641 propensity score-matched controls who met all study criteria; 352 treated patients who lacked matches were excluded from the study. Cox regression analysis of treated patients vs matched controls showed a significantly lower risk of mortality (HR = 0.62, 95% CI = 0.57-0.68); lower risk of hospitalization (HR = 0.71, 95% CI = 0.67-0.76; HR = 0.70, 95% CI = 0.64-0.76); and lower rate in number of hospitalizations per month (incident rate ratio [IRR] = 0.65, 95% CI = 0.60-0.71; IRR = 0.65, 95% CI = 0.58-0.73). This study suggests that treatment with antifibrotics may confer a survival benefit and protection against all-cause and respiratory-related hospitalization for IPF patients. : This work was sponsored by F. Hoffmann-La Roche/Genentech, Inc. Corral is employed by Genentech, Inc. Reddy, Chang, Broder, and Gokhale are employed by Partnership for Health Analytic Research LLC, a health services research company, which was hired by Genentech to conduct this research. Mooney has received advisory board/consulting fees and research support from Genentech, unrelated to this work. Mooney also reports advisory board/consulting fees and research support from Boehringer Ingelheim; personal fees from Imvaria; and grants from Celgene and Pliant, unrelated to this work. Through their employment with Partnership for Health Analytic Research, Reddy, Chang, Broder, and Gokhale have been compensated to conduct research for AbbVie, Akcea, ASPC, Amgen, AstraZeneca, BMS, Boston Scientific Corporation, Celgene, Eisai, Ethicon, GRAIL, Helsinn, Illumina, Innovation and Value Initiative, Ionis, Jazz, Kite, Novartis, Otsuka, Pathnostics, PhRMA, Prothena, Sage, Verde Technologies, Genentech, Inc., Greenwich Biosciences, Inc., Mirum Pharmaceuticals, Inc., Sanofi US Services, Inc., Sunovion Pharmaceuticals, Inc., and Dompe US, Inc., unrelated to this work. This research was presented as an abstract at CHEST 2020 Annual Meeting (virtual), October 18-21, 2020, and American Thoracic Society 2020 Virtual Meeting, June 2020.
需要更多的真实世界研究来更充分地阐明抗纤维化治疗在减缓特发性肺纤维化 (IPF) 进展方面的效果。本研究旨在比较 Medicare 受益人与开始抗纤维化治疗的 IPF 患者和未接受治疗的患者之间的死亡率和住院率。利用 Medicare 100%可研究识别文件,进行了一项 Medicare 受益人的回顾性观察性研究。我们纳入了在研究期间(2010 年 1 月 1 日至 2017 年 12 月 31 日)年龄在 67 岁及以上、诊断为 IPF(≥ 1 次住院或≥ 2 次门诊 IPF 诊断)的患者。2014 年 10 月 15 日(FDA 批准日期)至 2017 年 12 月 31 日(即治疗患者)期间开始接受抗纤维化治疗(吡非尼酮或尼达尼布)的患者与在抗纤维化药物可用之前(即 2012 年 1 月 1 日至 2014 年 10 月 14 日)的历史时期未接受治疗的患者(即未治疗的历史对照)进行比较。通过倾向评分匹配患者,并使用 Cox 比例风险模型比较死亡率和住院率(所有原因和呼吸相关)等结局。我们确定了 4641 名接受治疗的患者和 4641 名符合所有研究标准的匹配对照者;352 名接受治疗的患者因缺乏匹配而被排除在研究之外。对治疗患者与匹配对照者进行 Cox 回归分析显示,死亡率风险显著降低(HR = 0.62,95%CI = 0.57-0.68);住院风险降低(HR = 0.71,95%CI = 0.67-0.76;HR = 0.70,95%CI = 0.64-0.76);每月住院次数(发病率比 [IRR] = 0.65,95%CI = 0.60-0.71;IRR = 0.65,95%CI = 0.58-0.73)也减少。这项研究表明,抗纤维化治疗可能为 IPF 患者带来生存获益和预防全因及呼吸相关住院的益处。这项工作由罗氏/基因泰克公司赞助。Corral 受雇于基因泰克公司。Reddy、Chang、Broder 和 Gokhale 受雇于一家名为 Partnership for Health Analytic Research LLC 的健康服务研究公司,该公司受基因泰克公司聘请进行这项研究。Mooney 因与这项工作无关的原因,曾接受过基因泰克公司的顾问费和研究支持。Mooney 还报告了与勃林格殷格翰有关的顾问费和研究支持,与 Imvaria 有关的个人费用,以及与 Celgene 和 Pliant 有关的赠款。通过在 Partnership for Health Analytic Research 的工作,Reddy、Chang、Broder 和 Gokhale 因 AbbVie、Akcea、ASPC、Amgen、AstraZeneca、BMS、Boston Scientific Corporation、Celgene、Eisai、Ethicon、GRAIL、Helsinn、Illumina、Innovation and Value Initiative、Ionis、Jazz、Kite、Novartis、Otsuka、Pathnostics、PhRMA、Prothena、Sage、Verde Technologies、基因泰克公司、Greenwich Biosciences, Inc.、Mirum Pharmaceuticals, Inc.、Sanofi US Services, Inc.、Sunovion Pharmaceuticals, Inc. 和 Dompe US, Inc. 而获得了补偿,与这项工作无关。这项研究的结果作为摘要在 2020 年 CHEST 年会(虚拟会议)和 2020 年美国胸科学会虚拟会议上进行了介绍。