Deodhar Atul, Sandoval David, Holdsworth Elizabeth, Booth Nicola, Hunter Theresa
Oregon Health and Science University, Portland, OR, USA.
Eli Lilly and Company, Indianapolis, IN, USA.
Rheumatol Ther. 2020 Jun;7(2):415-423. doi: 10.1007/s40744-020-00208-5. Epub 2020 Apr 23.
The Food and Drug Administration (FDA) approved certolizumab-pegol, the first biologic for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA), for use in the United States (US) in March of 2019. The objective of this study was to investigate biologic use and reasons for switching therapy among patients with nr-axSpA in the US.
This was a real-world, cross-sectional study of rheumatologists conducted in the US. Data were collected from June to August of 2018 via rheumatologist-completed patient record forms. Data from patients who had a rheumatologist-confirmed diagnosis of nr-axSpA were included in the study. Rheumatologists provided information on current medication use and reasons for switching biologics.
Eighty-eight rheumatologists collected data on 495 nr-axSpA patients. Over half of nr-axSpA patients were male (53.3%), with a mean age of 44.2 years, and 69.8% of patients reported working full-time. Of the 495 nr-axSpA patients, 48.1% were receiving a biologic and no conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), 18.4% csDMARD (no biologic), 18.2% non-steroidal anti-inflammatory drug (NSAIDs)/COX-2 (no biologic or csDMARD), 11.5% a biologic and a csDMARD, 2.0% were receiving no therapy, and 1.8% other therapy (no biologic, csDMARD, or NSAID/COX-2). Of 295 patients receiving a biologic, 77.8% were receiving their first, 13.8% their second, and 8.3% their third or more biologic. Of 74 nr-axSpA patients who switched from a previous biologic to their current biologic, rheumatologists reported that 51.4% switched due to condition worsening, 48.6% had a loss of response over time, 27.0% switched due to a lack of pain alleviation, and 25.7% of patients switched because remission was not induced.
This study suggests that around 60% of nr-axSpA patients were receiving biologic therapy prior to the approval of certolizumab pegol. Switching of biologics is frequent in nr-axSpA patients and is usually due to lack of efficacy, loss or response, and effort to accomplish remission.
2019年3月，美国食品药品监督管理局（FDA）批准了聚乙二醇化赛妥珠单抗，这是首个用于治疗非放射学中轴型脊柱关节炎（nr-axSpA）的生物制剂。本研究的目的是调查美国nr-axSpA患者的生物制剂使用情况及换药原因。
这是一项在美国对风湿病学家开展的真实世界横断面研究。2018年6月至8月期间，通过风湿病学家填写的患者记录表收集数据。纳入经风湿病学家确诊为nr-axSpA的患者数据。风湿病学家提供了当前用药情况及更换生物制剂的原因。
88名风湿病学家收集了495例nr-axSpA患者的数据。超过半数的nr-axSpA患者为男性（53.3%），平均年龄44.2岁，69.8%的患者报告全职工作。在495例nr-axSpA患者中，48.1%正在接受生物制剂治疗且未使用传统合成改善病情抗风湿药（csDMARD），18.4%使用csDMARD（未使用生物制剂），18.2%使用非甾体抗炎药（NSAIDs）/环氧化酶-2抑制剂（COX-2）（未使用生物制剂或csDMARD），11.5%同时使用生物制剂和csDMARD，2.0%未接受任何治疗，1.8%接受其他治疗（未使用生物制剂、csDMARD或NSAIDs/COX-2）。在295例接受生物制剂治疗的患者中，77.8%使用的是第一种生物制剂，13.8%是第二种，8.3%是第三种或更多种生物制剂。在74例从之前的生物制剂换用当前生物制剂的nr-axSpA患者中，风湿病学家报告称，51.4%的患者因病情恶化而换药，48.6%的患者随着时间推移出现疗效丧失，27.0%的患者因疼痛未缓解而换药，25.7%的患者因未诱导出缓解而换药。
本研究表明，在聚乙二醇化赛妥珠单抗获批之前，约60%的nr-axSpA患者正在接受生物制剂治疗。nr-axSpA患者频繁更换生物制剂，通常是由于疗效不佳、疗效丧失或为实现缓解。
