Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.
Immunoscience Marketed Products, Bristol-Myers Squibb, Princeton, NJ, USA.
Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.
Response prediction of certain biologic agents for the treatment of rheumatoid arthritis (RA) remains an unmet need in real-world clinical practice. The contribution of patient-reported components to the 28-joint Disease Activity Score (DAS28) was termed DAS28-P and investigated as a predictor of response to biologic agents, mostly tumor necrosis factor inhibitors. We aimed to evaluate DAS28-P as a predictor of the European League Against Rheumatism (EULAR) response to abatacept in patients with RA.
The study population was a prospective, observational, multicenter cohort of Korean patients with RA, who were followed up for a nationwide post-marketing surveillance study of abatacept. Correlation of DAS28-P with DAS28, change of DAS28, and EULAR response groups were evaluated. Logistic regression analysis was used to predict good-to-moderate EULAR response to abatacept in the study population.
A total of 341 patients were involved in the analysis stratified on the EULAR response criteria. Presence of comorbidities, previous exposure to biologic agents, baseline DAS28, three of its components (tender joint counts, global health visual analog scale, erythrocyte sedimentation rate), and baseline DAS28-P were significantly associated with EULAR response to abatacept at 6 months. Stratified upon EULAR response, a group with good-to-moderate response had a higher baseline value and lower interval change for DAS28-P. Logistic regression analysis showed that a DAS28-P cut-off of > 0.44 was more positively associated with good-to-moderate EULAR response with abatacept treatment than naivety to biologic agents.
The DAS28-P could be predictive of response to abatacept. A higher baseline DAS28-P is associated with a favorable therapeutic response to abatacept.
Trial name, Korean Post-marketing Surveillance for Orencia. Trial registration number, NCT01583244. Registered on April 20, 2012.
在实际临床实践中,预测某些生物制剂治疗类风湿关节炎(RA)的疗效仍然是一个未满足的需求。患者报告的各项指标对 28 个关节疾病活动度评分(DAS28)的贡献被称为 DAS28-P,并被研究作为生物制剂反应的预测指标,主要是肿瘤坏死因子抑制剂。我们旨在评估 DAS28-P 作为预测接受 abatacept 治疗的 RA 患者对欧洲抗风湿病联盟(EULAR)反应的指标。
研究人群为接受 abatacept 全国上市后监测研究的前瞻性、观察性、多中心韩国 RA 患者队列。评估了 DAS28-P 与 DAS28、DAS28 变化和 EULAR 反应组之间的相关性。采用逻辑回归分析预测研究人群对 abatacept 的良好至中度 EULAR 反应。
根据 EULAR 反应标准对 341 例患者进行了分层分析。合并症、既往使用生物制剂、基线 DAS28、其三个组成部分(压痛关节数、总体健康视觉模拟评分、红细胞沉降率)和基线 DAS28-P 与 6 个月时 abatacept 的 EULAR 反应显著相关。根据 EULAR 反应分层,具有良好至中度反应的组具有更高的基线值和更低的 DAS28-P 间隔变化。逻辑回归分析显示,DAS28-P >0.44 的截点与 abatacept 治疗的良好至中度 EULAR 反应的相关性更强,而非生物制剂初治。
DAS28-P 可预测 abatacept 的反应。较高的基线 DAS28-P 与 abatacept 治疗的良好治疗反应相关。
韩国 Orencia 上市后监测。试验注册号:NCT01583244。注册日期:2012 年 4 月 20 日。