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比较 ACPA 和共享表位阳性的类风湿关节炎患者使用阿巴西普与 TNF 抑制剂的疗效。

Comparative effectiveness of abatacept versus TNF inhibitors in rheumatoid arthritis patients who are ACPA and shared epitope positive.

机构信息

CorEvitas, LLC, 350 5th Avenue, Waltham, MA, 02451, USA.

University of Massachusetts Medical School, Worcester, MA, USA.

出版信息

Adv Rheumatol. 2024 Jan 19;64(1):10. doi: 10.1186/s42358-024-00352-4.

Abstract

BACKGROUND

The HLA-DRB1 shared epitope (SE) is a risk factor for the development of rheumatoid arthritis (RA) and the production of anti-citrullinated protein antibodies (ACPAs) in RA patients. Our objective was to examine the real-world effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFi) in patients with RA who were SE and anti-cyclic citrullinated peptide antibody (anti-CCP3) positive.

METHODS

Abatacept or TNFi initiators who were SE + and anti-CCP3+ (> 20 U/mL) at or prior to treatment and had moderate or high CDAI score (> 10) at initiation were identified. The primary outcome was mean change in CDAI score over six months. Analyses were conducted in propensity score (PS)-trimmed and -matched populations overall and a biologic-experienced subgroup. Mixed-effects models were used.

RESULTS

In the overall PS-trimmed (abatacept, n = 170; TNFi, n = 157) and PS-matched cohorts (abatacept, n = 111; TNFi, n = 111), there were numerically greater improvements in mean change in CDAI between abatacept and TNFi but were not statistically significant. Similar trends were seen for biologic-experienced patients, except that statistical significance was reached for mean change in CDAI in the PS-trimmed cohort (abatacept, 12.22 [95% confidence interval (95%CI) 10.13 to 14.31]; TNFi, 9.28 [95%CI 7.08 to 11.48]; p = 0.045).

CONCLUSION

In this real world cohort, there were numerical improvements in efficacy outcomes with abatacept over TNFi in patients with RA who were SE + and ACPA+, similar to results from a clinical trial population The only statistically significant finding after adjusting for covariates was greater improvement in CDAI with abatacept versus TNFi in the bio-experienced PS-trimmed cohort..

摘要

背景

人类白细胞抗原-DRB1 共享表位(SE)是类风湿关节炎(RA)发展和 RA 患者产生抗瓜氨酸蛋白抗体(ACPAs)的风险因素。我们的目的是研究在 SE 和抗环瓜氨酸肽抗体(抗-CCP3)阳性的 RA 患者中,阿巴西普与肿瘤坏死因子抑制剂(TNFi)的真实世界疗效。

方法

在治疗时或治疗前 SE 阳性和抗-CCP3 阳性(>20 U/mL),且起始时 CDAI 评分中度或高度(>10)的阿巴西普或 TNFi 起始者被确定。主要结局是 6 个月时 CDAI 评分的平均变化。在倾向评分(PS)修剪和匹配的总体人群以及生物经验亚组中进行了分析。使用混合效应模型。

结果

在总体 PS 修剪(阿巴西普,n=170;TNFi,n=157)和 PS 匹配队列(阿巴西普,n=111;TNFi,n=111)中,阿巴西普与 TNFi 相比,CDAI 评分的平均变化有更大的改善,但无统计学意义。在生物经验患者中也出现了类似的趋势,但在 PS 修剪队列的 CDAI 评分平均变化方面达到了统计学意义(阿巴西普,12.22[95%置信区间(95%CI)10.13 至 14.31];TNFi,9.28[95%CI 7.08 至 11.48];p=0.045)。

结论

在这个真实世界的队列中,在 SE 阳性和 ACPA 阳性的 RA 患者中,阿巴西普在疗效方面有数值上的改善,优于临床试验人群的结果。在调整协变量后,唯一具有统计学意义的发现是在生物经验 PS 修剪队列中,与 TNFi 相比,阿巴西普在 CDAI 方面的改善更大。

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