Kiltz Uta, Tsiami Styliani, Baraliakos Xenofon, Andreica Ioana, Kiefer David, Braun Jürgen
Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany.
Ruhr-Universität Bochum, Bochum, Germany.
Ther Adv Musculoskelet Dis. 2022 Aug 26;14:1759720X221119593. doi: 10.1177/1759720X221119593. eCollection 2022.
Biosimilar disease-modifying anti-rheumatic drugs (bsDMARDs) has created a financial incentive to encourage switching to cheaper products.
We aim to study the effectiveness and safety of a non-medical bsDMARD-to-bsDMARD switch from originator etanercept (ETN) to bsDMARD ETN (SB4) and successive to another bsDMARD ETN (GP2015) in patients with chronic inflammatory rheumatic diseases in a real-life setting.
Retrospective chart review of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) who had been treated with originator ETN and were switched twice to ETN bsDMARD for non-medical reasons thereafter. All patients received ETN 50 mg/week. Disease activity and physical function was assessed every 12 weeks with standardized questionnaires.
A total of 100 patients who switched twice [54 RA, 27 axSpA, 19 PsA, mean age 54.3 (15.1), 46% male] were included. Patients with axSpA were younger than RA and PsA patients. Patients with SpA were less likely to receive conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) than RA patients. Duration of treatment with originator ETN before the first switch was 3.3 (2.3) years. Retention rate 6 months after the second ETN bsDMARD switch was 89%. Disease activity and physical function scores remained rather unchanged in patients with RA and axSpA longitudinally, while there was some more fluctuation in PsA patients. Six patients lost efficacy and were switched back to originator ETN in month 6 ( = 4) or to another mode of action ( = 2). There were 14 adverse events (AE) reported in eight patients. One patient re-administered bsDMARD GP2015 successfully 3 months after healing of mucosal erosions.
No relevant change in disease activity and physical function were observed in a non-medical bsDMARD-to-bsDMARD switch scenario. The retention rate after switches from originator ETN to two ETN bsDMARD was close to 90%. Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals.
生物类似物疾病改善抗风湿药物（bsDMARDs）产生了经济激励，以鼓励转向更便宜的产品。
我们旨在研究在现实生活环境中，慢性炎症性风湿性疾病患者从原研依那西普（ETN）非医学原因转换为bsDMARD依那西普（SB4），并随后转换为另一种bsDMARD依那西普（GP2015）的有效性和安全性。
对类风湿关节炎（RA）、银屑病关节炎（PsA）或轴向脊柱关节炎（axSpA）患者进行回顾性病历审查，这些患者曾接受原研ETN治疗，此后因非医学原因两次转换为ETN bsDMARD。所有患者接受每周50毫克ETN治疗。每12周用标准化问卷评估疾病活动度和身体功能。
共纳入100例两次转换的患者[54例RA、27例axSpA、19例PsA，平均年龄54.3（15.1）岁，46%为男性]。axSpA患者比RA和PsA患者年轻。SpA患者比RA患者接受传统合成疾病改善抗风湿药物（csDMARDs）的可能性更小。首次转换前原研ETN的治疗时长为3.3（2.3）年。第二次ETN bsDMARD转换后6个月的保留率为89%。RA和axSpA患者的疾病活动度和身体功能评分纵向保持相当稳定，而PsA患者有更多波动。6例患者在第6个月失去疗效，4例转回原研ETN，2例转换为另一种作用方式。8例患者报告了14例不良事件（AE）。1例患者在黏膜糜烂愈合3个月后成功重新使用bsDMARD GP2015。
在非医学的bsDMARD-to-bsDMARD转换情况下，未观察到疾病活动度和身体功能有相关变化。从原研ETN转换为两种ETN bsDMARD后的保留率接近90%。多次转换导致高依从率，无临床重要的疗效或安全信号。
