ACTION观察性研究中类风湿关节炎患者12个月静脉注射阿巴西普保留率的真实世界预测因素
Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study.
作者信息
Alten Rieke, Mariette Xavier, Lorenz Hanns-Martin, Galeazzi Mauro, Cantagrel Alain, Nüßlein Hubert G, Chartier Melanie, Elbez Yedid, Rauch Christiane, Le Bars Manuela
机构信息
Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology, Schlosspark-Klinik University Medicine, Berlin, Germany.
Department of Rheumatology, Université Paris-Sud, Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Le Kremlin Bicêtre, Paris, France.
出版信息
RMD Open. 2017 Dec 29;3(2):e000538. doi: 10.1136/rmdopen-2017-000538. eCollection 2017.
INTRODUCTION
An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearbataepn rutie clinical practice (ACTION) study.
METHODS
ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI).
RESULTS
Overall, 2350/2364 enrolled patients were evaluable (674 biologic naїve; 1676 biologic failure). Baseline characteristics were largely similar in biologic-naïve and biologic-failure groups. Crude retention rates (95% CI) at 12 months were significantly higher in biologic-naїve (78.1%(74.7% to 81.2%)) versus biologic-failure patients (69.9%(67.6% to 72.1%); P<0.001). RF/anti-CCP double positivity predicted higher retention in both patient groups, and remained associated with higher retention in patients with erosive disease. BMI did not impact abatacept retention in either patient group, irrespective of RF/anti-CCP serostatus. Good/moderate EULAR response rate at 12 months was numerically higher in biologic-naїve (83.8%) versus biologic-failure (73.3%) patients. There were no new safety signals.
CONCLUSION
High levels of intravenous abatacept retention in clinical practice were confirmed, particularly in biologic-naïve patients, including in those with poor RA prognostic factors. Retention was unaffected by BMI, regardless of RF/anti-CCP serostatus.
TRIAL REGISTRATION NUMBER
NCT02109666; retrospectively registered 8 April 2014.
引言
对阿巴西普持续用药的真实世界预测因素的了解有限。在一项针对两年期巴塔埃普常规临床实践（ACTION）研究的12个月中期分析中，我们分析了初治生物制剂和生物制剂治疗失败患者中阿巴西普的持续用药率及预测因素。
方法
ACTION是一项针对开始静脉注射阿巴西普的中重度类风湿关节炎（RA）患者的国际观察性研究。在这项12个月的中期分析中，评估了初治生物制剂和生物制剂治疗失败患者的阿巴西普粗持续用药率、持续用药的预测因素以及欧洲抗风湿病联盟（EULAR）反应。还根据类风湿因子（RF）和抗环瓜氨酸肽（CCP）状态、有无基线影像学侵蚀以及体重指数（BMI）评估了持续用药情况。
结果
总体而言，2364名入组患者中有2350名可评估（674名初治生物制剂患者；1676名生物制剂治疗失败患者）。初治生物制剂组和生物制剂治疗失败组的基线特征基本相似。初治生物制剂患者12个月时的粗持续用药率（95%CI）显著高于生物制剂治疗失败患者（分别为78.1%（74.7%至81.2%）和69.9%（67.6%至72.1%）；P<0.001）。RF/抗CCP双阳性在两组患者中均预测较高的持续用药率，并且在有侵蚀性疾病的患者中仍与较高的持续用药率相关。BMI在两组患者中均不影响阿巴西普的持续用药率，无论RF/抗CCP血清学状态如何。12个月时，初治生物制剂患者的良好/中度EULAR反应率在数值上高于生物制剂治疗失败患者（分别为83.8%和73.3%）。没有新的安全信号。
结论
证实了临床实践中静脉注射阿巴西普的高持续用药率，尤其是在初治生物制剂患者中，包括那些具有不良RA预后因素的患者。无论RF/抗CCP血清学状态如何，持续用药不受BMI影响。
试验注册号
NCT02109666；于2014年4月8日追溯注册。
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