Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Rheumatology (Oxford). 2023 Dec 1;62(12):3849-3857. doi: 10.1093/rheumatology/kead127.
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.
依那西普生物类似药在随机对照试验中显示出与生物初治 RA 患者的原研药物相当的疗效。2016 年，国家指南要求处方使用依那西普生物类似药，这导致了显著的成本节约。本分析旨在比较依那西普原研药与生物初治 RA 患者在英国常规临床实践中使用依那西普生物类似药的疗效。
纳入 2010 年开始在英国风湿病学会生物制剂登记处类风湿关节炎（BSRBR-RA）队列研究中接受依那西普治疗的生物初治 RA 患者。在开始治疗时收集的数据包括患者的人口统计学和疾病活动度。随访数据包括疾病活动度和抗风湿治疗的变化。6 个月和 12 个月的主要结局包括 28 个关节 DAS（DAS28）缓解、EULAR 反应和功能的最小临床重要差异。使用 Kaplan-Meier 和 Cox 回归评估依那西普药物的生存情况，包括治疗停药的原因。多重插补法用于处理缺失数据。倾向得分十分位数调整用于校正指示性混杂。
共纳入 1806 例生物初治 RA 患者开始接受依那西普治疗：1009 例原研药，797 例生物类似药。在 6 个月和 12 个月时，两种治疗方法达到 DAS28 缓解和 EULAR 反应的患者比例相似。在随访期间，19%的原研药患者转为使用依那西普生物类似药。患者在转换时被删失。与生物类似药相比，原研药患者停止治疗的可能性更小；原研药和生物类似药组分别有 71%和 76%的患者在 1 年时仍在接受治疗。
在最大规模的 RA 患者分析之一中，使用真实世界数据，生物初治 RA 患者接受依那西普原研药治疗与生物类似药治疗的结局相似。两组患者的药物生存率和治疗 6 个月和 12 个月后的疾病活动度相似。
