Baraliakos Xenofon, Szumski Annette E, Kwok Kenneth K, Vlahos Bonnie, Borlenghi Cecilia E
Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Claudiusstrasse 45, 44649, Bochum, Herne, Germany.
Syneos Health, Princeton, NJ, USA.
Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.
Short-term placebo (PBO)- or active-controlled clinical studies have demonstrated that etanercept (ETN) is effective and well tolerated in patients with radiographic axial spondyloarthritis (r-axSpA) with long-term efficacy and safety continuing for up to 7 years after treatment start. Short-term randomized controlled trials (RCTs) have shown the efficacy of ETN after 12-24 weeks, with statistically significant improvements as early as week 2. This post hoc analysis investigated the timeframe (i.e., temporal responses) in which patients with r-axSpA achieved their first clinical response with ETN and how patients responded over a longer period according to different temporal responses in index studies.
Data were analyzed from three phase 3/4 PBO- or sulfasalazine-controlled RCTs of ETN for the treatment of r-axSpA (index studies). Long-term open-label extension (OLE) studies assessed how patients responded over a longer period according to different temporal responses ("Early," "Intermediate," "Late," or "Non-response") in their corresponding index studies.
Within each index study, patient responses differed significantly between ETN and control arms for achievement of Assessment in SpondyloArthritis international Society (ASAS) 20 and other measures of treatment response. In general, the proportion of responders in the OLE studies was high for those with "Early" and "Intermediate" responses as defined in the index studies. Despite patients being considered non-responders in the index studies, a large proportion achieved response on continued treatment in the OLE studies over the longer term, including through 48 weeks.
Response in the index studies was maintained in the long term, and continued treatment was warranted in a large proportion of patients despite initial non-response. Absence of an early response in index studies did not predict non-response over the long term, and early response to treatment was not always a predictor for later response.
NCT00421915; NCT00247962; NCT00356356; NCT00421980; NCT00410046.
短期安慰剂（PBO）对照或活性药物对照的临床研究表明，对于放射学轴向脊柱关节炎（r-axSpA）患者，依那西普（ETN）有效且耐受性良好，治疗开始后长达7年都具有长期疗效和安全性。短期随机对照试验（RCT）显示，12 - 24周后ETN具有疗效，早在第2周就有统计学上的显著改善。这项事后分析研究了r-axSpA患者使用ETN首次出现临床反应的时间范围（即时间反应），以及在指数研究中根据不同时间反应患者在更长时期内的反应情况。
分析了三项ETN治疗r-axSpA的3/4期PBO对照或柳氮磺胺吡啶对照的RCT（指数研究）的数据。长期开放标签扩展（OLE）研究评估了患者在相应指数研究中根据不同时间反应（“早期”、“中期”、“晚期”或“无反应”）在更长时期内的反应情况。
在每项指数研究中，ETN组和对照组在达到国际脊柱关节炎协会（ASAS）20评估及其他治疗反应指标方面，患者反应存在显著差异。总体而言，对于指数研究中定义为“早期”和“中期”反应的患者，OLE研究中的反应者比例较高。尽管在指数研究中患者被视为无反应者，但在OLE研究中，很大一部分患者在长期持续治疗中包括在48周时都实现了反应。
指数研究中的反应在长期内得以维持，尽管最初无反应，但很大一部分患者仍需继续治疗。指数研究中早期无反应并不能预测长期无反应，治疗的早期反应也不总是后期反应的预测指标。
NCT00421915；NCT00247962；NCT00356356；NCT00421980；NCT00410046。
