Harrold Leslie R, Wittstock Keith, Kelly Sheila, Han Xue, Shan Ying, Guo Lin, Moore Page C, Khaychuk Vadim
CorEvitas, LLC, 1440 Main Street, Waltham, MA, 02451, USA.
University of Massachusetts Medical School, Worcester, MA, USA.
Rheumatol Ther. 2023 Jun;10(3):575-587. doi: 10.1007/s40744-022-00523-z. Epub 2023 Feb 7.
Currently there is limited data to drive clinical decision making regarding the choice of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARD); thus, head-to-head comparisons are needed to help guide prescribing. In recent years, significant advancements have helped clarify the mechanistic basis of the clinical associations of autoantibodies in rheumatoid arthritis (RA). This study evaluated the effectiveness of abatacept versus tofacitinib in anti-cyclic citrullinated peptide (CCP+) patients with rheumatoid arthritis (RA).
CorEvitas (formerly known as CORRONA) Registry patients aged ≥ 18 years, who were CCP+ before initiating abatacept or tofacitinib (December 2012 onwards through October 2019), had 6-month follow-up data (baseline and 6-month Clinical Disease Activity Index [CDAI]), and were not in remission at index were included. Patients were frequency matched 1:1 by prior biologic use before propensity score matching (PSM). Primary (mean change [D] in CDAI) and secondary outcomes 6 months after index were compared using mixed-effects models adjusted for variables that remained unbalanced after PSM.
Following PSM, most baseline characteristics for 291 patient pairs were well balanced between treatments, although fewer patients initiating abatacept versus tofacitinib received prior non-TNFi biologic DMARDs, and patients initiating abatacept versus tofacitinib had a higher physician global assessment score, patient-reported fatigue, and modified Health Assessment Questionnaire (mHAQ). In adjusted analyses, there were no significant differences in mean [D] from baseline in CDAI at 6 months with abatacept versus tofacitinib (P = 0.936). Patients naïve for b/tsDMARDs initiating abatacept had a numerically greater mean [D] in CDAI at 6 months versus tofacitinib, although this difference was not statistically significant (P = 0.662). There were no significant differences for any secondary outcomes.
In adjusted analyses, CCP+ patients with RA initiating treatment with abatacept versus tofacitinib did not show a statistically significant difference in reducing disease activity or improving patient-reported outcomes.
目前,关于生物制剂/靶向合成改善病情抗风湿药(DMARD)的选择,用于指导临床决策的数据有限;因此,需要进行直接比较以辅助处方。近年来,重大进展有助于阐明类风湿关节炎(RA)中自身抗体临床关联的机制基础。本研究评估了阿巴西普与托法替布在抗环瓜氨酸肽(CCP)阳性类风湿关节炎(RA)患者中的疗效。
纳入CorEvitas(原CORRONA)注册研究中年龄≥18岁的患者,这些患者在开始使用阿巴西普或托法替布之前(2012年12月起至2019年10月)CCP呈阳性,有6个月的随访数据(基线和6个月时的临床疾病活动指数[CDAI]),且在入组时未处于缓解状态。在倾向评分匹配(PSM)之前,根据既往生物制剂使用情况对患者进行1:1频率匹配。使用混合效应模型比较入组后6个月的主要结局(CDAI的平均变化[D])和次要结局,并对PSM后仍不平衡的变量进行调整。
PSM后,291对患者的大多数基线特征在治疗组间达到良好平衡,尽管与开始使用托法替布的患者相比,开始使用阿巴西普的患者接受既往非肿瘤坏死因子(TNFi)生物DMARDs治疗的人数较少,且开始使用阿巴西普的患者与开始使用托法替布的患者相比,医生整体评估得分、患者报告的疲劳程度以及改良健康评估问卷(mHAQ)更高。在调整分析中,使用阿巴西普与托法替布治疗6个月时,CDAI相对于基线的平均[D]无显著差异(P = 0.936)。开始使用阿巴西普的初治b/tsDMARDs患者在6个月时CDAI的平均[D]数值上高于托法替布,尽管这种差异无统计学意义(P = 0.662)。任何次要结局均无显著差异。
在调整分析中,CCP阳性的RA患者开始使用阿巴西普与托法替布治疗,在降低疾病活动度或改善患者报告结局方面未显示出统计学上的显著差异。