Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study.

IF 4.5 Q2 PHARMACOLOGY & PHARMACY

Pharmaceutical Medicine Pub Date : 2025-07-16 DOI:10.1007/s40290-025-00577-8

Chin Hang Yiu, Bella D Ianni, Richard O Day, Jacques Raubenheimer, Christine Y Lu

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引用次数: 0

Abstract

Background: Australia has one of the highest rates of rheumatoid arthritis (RA) worldwide. Etanercept, a widely used biologic for severe RA, has had a publicly subsidised biosimilar available in Australia since 2017. However, real-world data on how biosimilar availability has affected treatment patterns remain limited.

Objective: This study aimed to assess treatment persistence-a surrogate measure of long-term treatment effectiveness-with etanercept before and after public subsidy of its biosimilar for RA, utilising a national sample.

Methods: This retrospective cohort study analysed national healthcare claims data from the Pharmaceutical Benefits Scheme (PBS) via the Australian Bureau of Statistics DataLab. Adults (age ≥ 18 years) initiating etanercept for severe RA were stratified into two cohorts: historical (before biosimilar PBS listing, comprising only originator users) and contemporary (after biosimilar PBS listing, comprising both biosimilar and originator users). Kaplan-Meier analysis and multivariate Cox regression were employed to assess treatment persistence. Subgroup analysis of older adults and sensitivity analysis limited to biologic-naïve individuals were also performed.

Results: A total of 10,234 individuals initiating etanercept for severe RA were included, with 4461 in the historical cohort and 5773 in the contemporary cohort. The median time to treatment discontinuation was 10.0 months (95% confidence interval (CI) 9.7-10.6) in the contemporary cohort and 10.6 months (95% CI 10.0-11.4) in the historical cohort (p = 0.08). At 12 and 24 months, treatment retention rates were similar between cohorts. The adjusted hazard ratio for treatment discontinuation in the contemporary cohort was 1.00 (95% CI 0.96-1.05), indicating no significant differences. Subgroup and sensitivity analyses yielded similar results.

Conclusion: This large, population-based study found no significant difference in treatment persistence following the introduction of the etanercept biosimilar in Australia. These findings support the real-world integration of biosimilars into routine care. Further research should include direct comparative analyses of originator and biosimilars to inform long-term treatment strategies, clinician confidence, and sustainable healthcare policy.

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依那西普生物仿制药前后类风湿关节炎治疗持续性的研究

背景：澳大利亚是世界上类风湿性关节炎（RA）发病率最高的国家之一。依那西普是一种广泛用于治疗严重类风湿性关节炎的生物制剂，自2017年以来，澳大利亚已经有了一种公共补贴的生物仿制药。然而，关于生物类似药可用性如何影响治疗模式的实际数据仍然有限。目的：本研究旨在利用国家样本评估依那西普在RA生物类似药公共补贴前后的治疗持久性——长期治疗有效性的替代指标。方法：本回顾性队列研究通过澳大利亚统计局数据实验室分析了来自药品福利计划（PBS）的国家医疗保健索赔数据。使用依那西普治疗严重RA的成人（年龄≥18岁）被分为两组：历史组（生物类似药上市前，仅包括原药使用者）和当代组（生物类似药上市后，包括生物类似药和原药使用者）。Kaplan-Meier分析和多变量Cox回归评估治疗持续性。还进行了老年人亚组分析和仅限于biologic-naïve个体的敏感性分析。结果：共纳入10234例使用依那西普治疗严重RA的患者，其中4461例来自历史队列，5773例来自当代队列。当代队列的中位停药时间为10.0个月（95%可信区间（CI） 9.7-10.6），历史队列的中位停药时间为10.6个月（95% CI 10.0-11.4）（p = 0.08）。在12个月和24个月时，各组之间的治疗保留率相似。在当代队列中，治疗中断的校正风险比为1.00 (95% CI 0.96-1.05)，表明无显著差异。亚组分析和敏感性分析得出了类似的结果。结论：这项基于人群的大型研究发现，在澳大利亚引入依那西普生物类似药后，治疗持久性没有显著差异。这些发现支持将生物仿制药纳入日常护理的现实世界。进一步的研究应包括对原研药和生物仿制药的直接比较分析，以便为长期治疗策略、临床医生信心和可持续的医疗保健政策提供信息。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-

CiteScore

5.10

自引率

4.00%

发文量

期刊介绍： Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.