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乌帕替尼治疗24周时初治和生物制剂治疗失败的类风湿关节炎患者的临床和超声缓解:UPARAREMUS真实世界研究

Clinical and Ultrasonographic Remission in Bio-naïve and Bio-failure Patients with Rheumatoid Arthritis at 24 Weeks of Upadacitinib Treatment: The UPARAREMUS Real-Life Study.

作者信息

Picchianti Diamanti Andrea, Cattaruzza Maria Sofia, Salemi Simonetta, Di Rosa Roberta, Sesti Giorgio, De Lorenzo Chiara, Felice Gloria Maria, Frediani Bruno, Baldi Caterina, Chimenti Maria Sole, D'Antonio Arianna, Crepaldi Gloria, Luchetti Michele Maria, Paci Valentino, Zabotti Alen, Giovannini Ivan, Canzoni Marco, Sebastiani Giandomenico, Scirocco Chiara, Perricone Carlo, Laganà Bruno, Iagnocco Annamaria

机构信息

Department of Clinical and Molecular Medicine, "Sapienza" University of Rome, S. Andrea University Hospital, 00189, Rome, Italy.

Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185, Rome, Italy.

出版信息

Rheumatol Ther. 2024 Oct;11(5):1347-1361. doi: 10.1007/s40744-024-00712-y. Epub 2024 Aug 23.

DOI:10.1007/s40744-024-00712-y
PMID:39177745
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11422397/
Abstract

INTRODUCTION

Clinical remission is the main target in the management of patients with rheumatoid arthritis (RA). However, several authors found synovitis in patients with RA in clinical remission at ultrasonography (US). Upadacitinib is a selective Janus kinase 1 inhibitor that achieved significantly higher remission rates than adalimumab and abatacept in patients with RA. Here we present the 24-week data of the UPAdacitinib Rheumatoid Arthritis REmission UltraSonography (UPARAREMUS) study.

METHODS

This is a longitudinal multicenter observational study, enrolling bio-naïve and bio-inadequate responder patients affected by RA. The primary endpoint was the proportion of patients achieving both clinical and US remission at week 24. The proportion of patients achieving clinical remission with different composite indexes at week 12 and 24 was also evaluated. US of four target joints (wrists and second metacarpophalangeal bilaterally) was performed at baseline and weeks 12/24, and US remission was defined as the absence of power Doppler (PD) signal ≥ 2 in one target joint, or PD ≥ 1 in two target joints.

RESULTS

After 12 weeks and 24 weeks, 40% and 63.6% of patients achieved US plus clinical remission. The following parameters were associated with US plus clinical remission: being bio-naïve and having a shorter disease duration, although at multivariate analysis significant odds ratio (OR) was found only for being bio-naïve.

CONCLUSIONS

UPARAREMUS is the first study evaluating the efficacy of upadacitinib in reaching both clinical and US remission in patients with RA. At 24 weeks, 63.6% of patients reached the primary endpoint, the only baseline associated parameter was being bio-naïve.

摘要

引言

临床缓解是类风湿关节炎(RA)患者管理的主要目标。然而,一些作者在超声检查(US)中发现临床缓解的RA患者存在滑膜炎。乌帕替尼是一种选择性Janus激酶1抑制剂,在RA患者中实现的缓解率显著高于阿达木单抗和阿巴西普。在此,我们展示了乌帕替尼类风湿关节炎缓解超声检查(UPARAREMUS)研究的24周数据。

方法

这是一项纵向多中心观察性研究,纳入初治和生物治疗反应不佳的RA患者。主要终点是在第24周实现临床和超声缓解的患者比例。还评估了在第12周和24周使用不同综合指标实现临床缓解的患者比例。在基线以及第12/24周对四个目标关节(双侧手腕和第二掌指关节)进行超声检查,超声缓解定义为一个目标关节中无功率多普勒(PD)信号≥2,或两个目标关节中PD≥1。

结果

12周和24周后,40%和63.6%的患者实现了超声加临床缓解。以下参数与超声加临床缓解相关:初治且病程较短,尽管在多变量分析中仅发现初治具有显著优势比(OR)。

结论

UPARAREMUS是第一项评估乌帕替尼在RA患者中实现临床和超声缓解疗效的研究。在24周时,63.6%的患者达到主要终点,唯一与基线相关的参数是初治。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/44e75f1b7bda/40744_2024_712_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/78a9ee6f0f18/40744_2024_712_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/d3c69153e7ea/40744_2024_712_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/44e75f1b7bda/40744_2024_712_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/78a9ee6f0f18/40744_2024_712_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/d3c69153e7ea/40744_2024_712_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bed/11422397/44e75f1b7bda/40744_2024_712_Fig3_HTML.jpg

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