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早期使用阿巴西普与肿瘤坏死因子抑制剂治疗合并不良预后因素的类风湿关节炎的疗效对比

Persistence with Early-Line Abatacept versus Tumor Necrosis Factor-Inhibitors for Rheumatoid Arthritis Complicated by Poor Prognostic Factors.

作者信息

Han Xue, Lobo Francis, Broder Michael S, Chang Eunice, Gibbs Sarah N, Ridley David J, Yermilov Irina

机构信息

Bristol-Myers Squibb Company, Health Economics and Outcomes Research, Princeton, NJ.

Partnership for Health Analytic Research (PHAR), LLC, Beverly Hills, CA.

出版信息

J Health Econ Outcomes Res. 2021 May 19;8(1):71-78. doi: 10.36469/jheor.2021.23684.

Abstract

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians. To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity). We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented. Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], =0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, =0.012) and median time to discontinuation was longer (961 days versus 581 days, =0.048) in abatacept versus TNFi patients. Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis. In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.

摘要

类风湿关节炎(RA)是一种慢性炎症性疾病,其特征为关节肿胀和破坏,可导致严重残疾。关于治疗顺序尚无明确指南。收集临床试验环境之外的治疗模式数据可为临床医生提供有用的背景信息。为评估早期使用阿巴西普与肿瘤坏死因子抑制剂(TNFi)治疗的合并不良预后因素(包括抗环瓜氨酸肽抗体[ACPA]和类风湿因子[RF]血清阳性)的RA患者的真实世界治疗持续性。我们进行了一项多中心回顾性病历审查。合并不良预后因素的成年RA患者在诊所接受阿巴西普或TNFi作为首次生物治疗。不良预后因素包括ACPA阳性、RF阳性、C反应蛋白水平升高、红细胞沉降率水平升高或存在关节侵蚀。我们报告了阿巴西普与TNFi治疗患者的12个月治疗持续性、停药时间、停药原因及停药风险。呈现了ACPA阳性和/或RF阳性患者亚组中的部分结果。收集了265例患者的数据(100例使用阿巴西普,165例使用TNFi)。12个月时,83%的阿巴西普治疗患者持续治疗,而TNFi治疗患者为66.1%(P=0.003)。阿巴西普组的中位停药时间为1423天,而TNFi组为690天(P=0.014)。在调整分析中,阿巴西普治疗患者因疾病进展而停用指数治疗的风险较低(0.3[95%置信区间(CI):0.1-0.6],P=0.001)。在ACPA阳性和/或RF阳性患者亚组(55例使用阿巴西普,108例使用TNFi)中,未调整的12个月治疗持续性更高(83.6%对64.8%,P=0.012),阿巴西普治疗患者的中位停药时间更长(961天对581天,P=0.048)。合并不良预后因素的RA患者使用阿巴西普治疗,包括ACPA和RF血清阳性患者亚组,其12个月治疗持续性在统计学上显著高于使用TNFi治疗的患者,且停药时间更长。在真实世界中,与使用TNFi治疗的患者相比,使用阿巴西普治疗的RA患者更有可能长期坚持治疗且停药风险更低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92b5/8133796/f0a8895b09a4/jheor_2021_8_1_23684_61167.jpg

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