PDF(Pubmed)
Abstract：
Etanercept biosimilars show comparable efficacy to their originators among biologic-naïve patients with RA in randomized controlled trials. Nationwide guidelines have obligated prescribing of etanercept biosimilars from 2016, resulting in significant cost savings. This analysis aimed to compare the effectiveness of etanercept originator vs etanercept biosimilar amongst biologic-naïve RA patients treated in routine clinical practice in the UK.
Biologic-naïve RA patients starting etanercept in the British Society for Rheumatology Biologics Register in Rhematoid Arthritis (BSRBR-RA) cohort study from 2010 were included. Data collected at start of therapy includes patient demographics and disease activity. Follow-up data includes changes in disease activity and anti-rheumatic therapy. Six- and 12-month primary outcomes include DAS for 28-joints (DAS28) remission, EULAR response and minimal clinically important difference in function. Etanercept drug survival was assessed using Kaplan-Meier and Cox regression, including reasons for treatment withdrawal. Multiple imputation accounted for missing data. Propensity-decile adjustment was used to account for confounding by indication.
A total of 1806 biologic-naïve RA patients started etanercept: 1009 originator, 797 biosimilar. At 6 and 12 months, the proportion of patients achieving DAS28 remission and EULAR response were similar between treatments. During follow-up, 19% of originator patients switched onto etanercept biosimilar. Patients were censored at time of switch. Patients on originator were no more likely to stop therapy vs biosimilar; 71% of originator and 76% of biosimilar patients remained on therapy at 1 year.
In one of the largest analyses of patients with RA, biologic-naïve RA patients treated with etanercept originator showed similar outcomes vs biosimilar using real-world data. Drug survival, and disease activity after 6 and 12 months of therapy, was similar between cohorts.
Biologic-naïve RA patients starting etanercept in the British Society for Rheumatology Biologics Register in Rhematoid Arthritis (BSRBR-RA) cohort study from 2010 were included. Data collected at start of therapy includes patient demographics and disease activity. Follow-up data includes changes in disease activity and anti-rheumatic therapy. Six- and 12-month primary outcomes include DAS for 28-joints (DAS28) remission, EULAR response and minimal clinically important difference in function. Etanercept drug survival was assessed using Kaplan-Meier and Cox regression, including reasons for treatment withdrawal. Multiple imputation accounted for missing data. Propensity-decile adjustment was used to account for confounding by indication.
A total of 1806 biologic-naïve RA patients started etanercept: 1009 originator, 797 biosimilar. At 6 and 12 months, the proportion of patients achieving DAS28 remission and EULAR response were similar between treatments. During follow-up, 19% of originator patients switched onto etanercept biosimilar. Patients were censored at time of switch. Patients on originator were no more likely to stop therapy vs biosimilar; 71% of originator and 76% of biosimilar patients remained on therapy at 1 year.
In one of the largest analyses of patients with RA, biologic-naïve RA patients treated with etanercept originator showed similar outcomes vs biosimilar using real-world data. Drug survival, and disease activity after 6 and 12 months of therapy, was similar between cohorts.
摘要：
目的：依那西普生物仿制药在RCTs中显示与其鼻祖相当的疗效。从2016年开始，全国范围的指南都有义务开具依那西普生物仿制药的处方，从而节省了大量成本。本分析旨在比较依那西普鼻祖与依那西普生物仿制药在英国常规临床实践中治疗的生物性RA患者中的有效性。
方法：纳入了2010年BSRBR-RA队列研究中开始依那西普治疗的未治疗RA患者。在治疗开始时收集的数据包括患者人口统计学和疾病活动。随访数据包括疾病活动和抗风湿治疗的变化。6个月和12个月的主要结果包括28个关节（DAS28）缓解的疾病活动评分，欧拉反应,和最小的临床重要差异（MCID）的功能。使用Kaplan-Meier和Cox回归评估依那西普药物的生存率，包括治疗退出的原因。多重填补占数据缺失。倾向十分位数调整用于解释适应症的混淆。
结果：1806名生物性初治RA患者开始使用依那西普：1009名发起人，797生物仿制药。在6个月和12个月的时候，达到DAS28缓解的患者比例，治疗之间的EULAR反应相似。随访期间,19%的发起人患者改用依那西普生物仿制药。患者在转换时被审查。与生物仿制药相比，鼻祖患者不太可能停止治疗；71％的鼻祖患者和76％的生物仿制药患者在一年内仍在接受治疗。
结论：在最大的RA患者分析之一中，根据真实世界数据,接受依那西普鼻祖治疗的生物初治RA患者与生物仿制药的结果相似.药物生存，治疗6个月和12个月后的疾病活动，队列之间相似。
方法：纳入了2010年BSRBR-RA队列研究中开始依那西普治疗的未治疗RA患者。在治疗开始时收集的数据包括患者人口统计学和疾病活动。随访数据包括疾病活动和抗风湿治疗的变化。6个月和12个月的主要结果包括28个关节（DAS28）缓解的疾病活动评分，欧拉反应,和最小的临床重要差异（MCID）的功能。使用Kaplan-Meier和Cox回归评估依那西普药物的生存率，包括治疗退出的原因。多重填补占数据缺失。倾向十分位数调整用于解释适应症的混淆。
结果：1806名生物性初治RA患者开始使用依那西普：1009名发起人，797生物仿制药。在6个月和12个月的时候，达到DAS28缓解的患者比例，治疗之间的EULAR反应相似。随访期间,19%的发起人患者改用依那西普生物仿制药。患者在转换时被审查。与生物仿制药相比，鼻祖患者不太可能停止治疗；71％的鼻祖患者和76％的生物仿制药患者在一年内仍在接受治疗。
结论：在最大的RA患者分析之一中，根据真实世界数据,接受依那西普鼻祖治疗的生物初治RA患者与生物仿制药的结果相似.药物生存，治疗6个月和12个月后的疾病活动，队列之间相似。
