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在美国Corrona注册研究中,阿巴西普与托珠单抗对先前使用过肿瘤坏死因子抑制剂的类风湿关节炎患者的疗效比较

Comparative effectiveness of abatacept versus tocilizumab in rheumatoid arthritis patients with prior TNFi exposure in the US Corrona registry.

作者信息

Harrold Leslie R, Reed George W, Solomon Daniel H, Curtis Jeffrey R, Liu Mei, Greenberg Jeffrey D, Kremer Joel M

机构信息

Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, AC7-201, Worcester, MA, 01655, USA.

Corrona, LLC, Southborough, MA, USA.

出版信息

Arthritis Res Ther. 2016 Dec 1;18(1):280. doi: 10.1186/s13075-016-1179-7.

Abstract

BACKGROUND

We compared the effectiveness of abatacept (ABA) vs tocilizumab (TCA) in tumor necrosis factor inhibitor (TNFi) experienced patients.

METHODS

We identified rheumatoid arthritis (RA) patients from a large observational US cohort (1 January 2010-31 May 2014) who had discontinued at least one TNFi and initiated ABA or TCZ in moderate or high disease activity based on the Clinical Disease Activity Index (CDAI) and had no prior exposure to the comparator drug. Using propensity score matching (1:1) stratified by prior TNF use (1 TNFi vs ≥2 TNFis), effectiveness at 6 months after initiation was evaluated. Mean change in CDAI over 6 months following initiation was the primary outcome, with secondary outcomes of achievement of low disease activity/remission (CDAI ≤ 10) and mean change in modified Health Assessment Questionnaire (mHAQ) score.

RESULTS

The 264 pairs of propensity score-matched ABA and TCZ initiators were well matched with no substantial differences in the baseline characteristics, defined as standardized differences >0.1 in the stratification. Both treatment groups had similar mean change in CDAI at 6 months (-11.3 in ABA vs -9.9 in TCZ; mean difference -1.27, 95% CI -3.65, 1.11). Similar proportions of both treatment groups achieved low disease activity/remission (adjusted odds ratio for ABA vs TCZ 0.99, 95% CI 0.69, 1.43). Mean change in mHAQ was -0.12 in ABA initiators vs -0.11 in TCZ initiations (mean difference -0.01, 95% CI -0.09, 0.06).

CONCLUSIONS

Patients receiving either ABA or TCZ had substantial improvement in clinical disease activity. In this propensity score-matched sample, similar outcomes were observed for both treatment cohorts.

摘要

背景

我们比较了阿巴西普(ABA)与托珠单抗(TCA)在使用过肿瘤坏死因子抑制剂(TNFi)的患者中的疗效。

方法

我们从美国一个大型观察性队列(2010年1月1日至2014年5月31日)中识别出类风湿性关节炎(RA)患者,这些患者至少停用了一种TNFi,并根据临床疾病活动指数(CDAI)在中度或高度疾病活动时开始使用ABA或TCZ,且之前未接触过对照药物。采用倾向评分匹配(1:1),按既往TNF使用情况(1种TNFi与≥2种TNFi)分层,评估开始治疗后6个月的疗效。开始治疗后6个月内CDAI的平均变化是主要结局,次要结局为达到低疾病活动度/缓解(CDAI≤10)以及改良健康评估问卷(mHAQ)评分的平均变化。

结果

264对倾向评分匹配的ABA和TCZ起始治疗者匹配良好,分层中基线特征无显著差异,定义为标准化差异>0.1。两个治疗组在6个月时CDAI的平均变化相似(ABA组为-11.3,TCZ组为-9.9;平均差异-1.27,95%CI -3.65,1.11)。两个治疗组达到低疾病活动度/缓解的比例相似(ABA组与TCZ组的调整优势比为0.99,95%CI 0.69,1.43)。ABA起始治疗者的mHAQ平均变化为-0.12,TCZ起始治疗者为-0.11(平均差异-0.01,95%CI -0.09,0.06)。

结论

接受ABA或TCZ治疗的患者临床疾病活动度有显著改善。在这个倾向评分匹配的样本中,两个治疗队列观察到相似的结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d092/5134270/33704e6e65e7/13075_2016_1179_Fig1_HTML.jpg

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