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早期类风湿关节炎中自身抗体富集的益处:四项阿巴西普合并试验的疗效结果分析

Benefits of Autoantibody Enrichment in Early Rheumatoid Arthritis: Analysis of Efficacy Outcomes in Four Pooled Abatacept Trials.

作者信息

Michaud Kaleb, Conaghan Philip G, Park Sang Hee, Lozenski Karissa, Fillbrunn Mirko, Khaychuk Vadim, Swallow Elyse, Vaile John, Lane Henry, Nguyen Ha, Pope Janet

机构信息

University of Nebraska Medical Center, Omaha, NE, USA.

FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA.

出版信息

Rheumatol Ther. 2023 Aug;10(4):951-967. doi: 10.1007/s40744-023-00552-2. Epub 2023 May 25.

Abstract

INTRODUCTION

The efficacy of abatacept is enhanced in anti-citrullinated protein antibody (ACPA) and rheumatoid factor (RF)-positive versus -negative patients with rheumatoid arthritis (RA). Four early RA abatacept trials were analyzed to understand the differential impact of abatacept among patients with SeroPositive Early and Active RA (SPEAR) compared to non-SPEAR patients.

METHODS

Pooled patient-level data from AGREE, AMPLE, AVERT, and AVERT-2 were analyzed. Patients were classified as SPEAR if they were ACPA +, RF +, disease duration < 1 year, and Disease Activity Score-28 (DAS28) C-reactive protein (CRP) ≥ 3.2 at baseline; non-SPEAR otherwise. Outcomes included: American College of Rheumatology (ACR) 20/50/70 at week 24; mean change from baseline to week 24 for DAS28 (CRP), Simple Disease Activity Index (SDAI), ACR core components; DAS28 (CRP) and SDAI remission. Adjusted regression analyses among abatacept-treated patients compared SPEAR and non-SPEAR patients, and in full trial population estimating how the efficacy of abatacept versus comparators [adalimumab + methotrexate, methotrexate] was modified by SPEAR status.

RESULTS

The study included 1400 SPEAR and 673 non-SPEAR patients; most were female (79.35%), white (77.38%), and with a mean age 49.26 (SD 12.86) years old. Around half with non-SPEAR were RF + and three-quarters ACPA +. Stronger improvements from baseline to week 24 were observed in almost all outcomes for abatacept-treated SPEAR versus non-SPEAR patients or versus SPEAR patients treated with comparators. Larger improvements were observed for SPEAR patients among the abatacept-treated population, and more strongly improved efficacy among SPEAR patients for abatacept than comparators.

CONCLUSIONS

This analysis, including large patient numbers of early-RA abatacept trials, confirmed beneficial treatment effects of abatacept in patients with SPEAR versus non-SPEAR.

摘要

引言

与抗瓜氨酸化蛋白抗体(ACPA)和类风湿因子(RF)阴性的类风湿关节炎(RA)患者相比,阿巴西普在ACPA和RF阳性患者中的疗效更佳。对四项早期RA阿巴西普试验进行分析,以了解与非血清阳性早期活动性RA(SPEAR)患者相比,阿巴西普在SPEAR患者中的不同影响。

方法

分析来自AGREE、AMPLE、AVERT和AVERT - 2的汇总患者水平数据。如果患者ACPA阳性、RF阳性、疾病病程<1年且基线时疾病活动评分-28(DAS28)C反应蛋白(CRP)≥3.2,则分类为SPEAR;否则为非SPEAR。结局指标包括:第24周时美国风湿病学会(ACR)20/50/70;从基线到第24周DAS28(CRP)、简化疾病活动指数(SDAI)、ACR核心成分的平均变化;DAS28(CRP)和SDAI缓解情况。在接受阿巴西普治疗的患者中进行调整后的回归分析,比较SPEAR和非SPEAR患者,并在整个试验人群中估计SPEAR状态如何改变阿巴西普与对照药物[阿达木单抗+甲氨蝶呤、甲氨蝶呤]相比的疗效。

结果

该研究纳入了1400例SPEAR患者和673例非SPEAR患者;大多数为女性(79.35%)、白人(77.38%),平均年龄49.26(标准差12.86)岁。非SPEAR患者中约一半RF阳性,四分之三ACPA阳性。与非SPEAR患者或与接受对照药物治疗的SPEAR患者相比,接受阿巴西普治疗的SPEAR患者从基线到第24周几乎在所有结局指标上均有更显著改善。在接受阿巴西普治疗的人群中,SPEAR患者改善更大,且与对照药物相比,阿巴西普在SPEAR患者中的疗效改善更明显。

结论

这项分析纳入了大量早期RA阿巴西普试验患者,证实了阿巴西普对SPEAR患者与非SPEAR患者相比具有有益的治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6863/10326171/d1d1d8501850/40744_2023_552_Fig1_HTML.jpg

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