阿达木单抗生物原研药转换为生物类似药后的疗效——一项在欧洲国家使用真实世界患者和医生报告数据的比较
Outcomes Following Adalimumab Bio-originator to Biosimilar Switch-A Comparison Using Real-world Patient- and Physician-Reported Data in European Countries.
作者信息
Taylor Peter C, Gonzalez Yuri Sanchez, Clark Ryan, Faccin Freddy, Howell Oliver
机构信息
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, UK.
AbbVie Inc, North Chicago, IL, 60064, USA.
出版信息
Rheumatol Ther. 2023 Apr;10(2):433-445. doi: 10.1007/s40744-022-00526-w. Epub 2023 Jan 12.
INTRODUCTION
The aim of this work is to compare real-world outcomes of patients with rheumatoid arthritis (RA) receiving adalimumab (ADA) bio-originator (non-switchers) to those who had switched from ADA bio-originator to an ADA biosimilar (switchers) on the basis of the hypothesis that these outcomes would differ.
METHODS
Data were drawn from the Adelphi RA Disease Specific Programme™, a point-in-time survey of physicians and their patients in Europe (France, Germany, Italy, Spain, UK) in 2020. Physicians completed a questionnaire for their next ten adult patients with RA, followed by four additional patients who had switched from ADA bio-originator to an ADA biosimilar (switchers). Physician- and patient-reported outcomes (PROs) for switchers and non-switchers were compared by propensity score matching.
RESULTS
Three hundred and three rheumatologists provided data for 160 non-switchers and 225 switchers, 140 patients provided data; 51 non-switchers, 89 switchers. According to physician-reported disease activity, non-switchers were more likely to improve on their current ADA treatment than switchers (68%, n = 108 vs. 26%, n = 59 p < 0.001) and less likely to worsen (1%, n = 2 vs. 9%, n = 20; p < 0.01). Physician-reported patient adherence was significantly lower amongst switchers versus non-switchers (0.66 vs. 0.78, respectively; p = 0.04). More non-switchers than switchers were reported by their physicians to be consistent in taking their RA medicine (p < 0.001). Compared with non-switchers, PRO measures indicated quality of life was worse (EQ-5D Visual Analogue Scale: 62.9 vs. 71.9; p < 0.001) and activity impairment was greater (Work Productivity Activity Index: 31.0 vs. 24.4; p = 0.02) for switchers, with trends for poorer health status and greater pain.
CONCLUSIONS
Non-medical switching in RA treatment may lead to unforeseen outcomes that should be considered by health decision-makers.
引言
本研究旨在比较接受阿达木单抗（ADA）生物原研药治疗的类风湿关节炎（RA）患者（未换药者）与基于这些结果会有所不同的假设而从ADA生物原研药换用ADA生物类似药的患者（换药者）的真实世界结局。
方法
数据取自阿德尔菲RA疾病特定项目™，这是一项2020年对欧洲（法国、德国、意大利、西班牙、英国）医生及其患者的时间点调查。医生为其接下来的10名成年RA患者填写问卷，随后为另外4名从ADA生物原研药换用ADA生物类似药的患者（换药者）填写问卷。通过倾向得分匹配比较换药者和未换药者的医生报告结局和患者报告结局（PROs）。
结果
303名风湿病学家为160名未换药者和225名换药者提供了数据，140名患者提供了数据；51名未换药者，89名换药者。根据医生报告的疾病活动情况，未换药者在当前ADA治疗上改善的可能性高于换药者（68%，n = 108 vs. 26%，n = 59；p < 0.001），恶化的可能性更低（1%，n = 2 vs. 9%，n = 20；p < 0.01）。医生报告的患者依从性在换药者中显著低于未换药者（分别为0.66和0.78；p = = 0.04）。医生报告称，服用RA药物持续的未换药者比换药者更多（p < 0.001）。与未换药者相比，PRO测量表明，换药者的生活质量更差（EQ - 5D视觉模拟量表：62.9 vs. 71.9；p < 0.001），活动障碍更大（工作效率活动指数：31.0 vs. 24.4；p = 0.02），健康状况较差和疼痛更严重的趋势明显。
结论
RA治疗中的非医学换药可能导致意外结局，卫生决策者应予以考虑。
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