Sparks Jeffrey A, Dieudé Philippe, Hoffmann-Vold Anna-Maria, Burmester Gerd R, Walsh Simon Lf, Kreuter Michael, Stock Christian, Sambevski Steven, Alves Margarida, Emery Paul
Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, #6016U, Boston, MA, 02115, USA.
Department of Rheumatology, Bichat-Claude Bernard University Hospital, Assistance Publique-Hôpitaux de Paris, INSERM UMR1152, University of Paris, Paris, France.
BMC Rheumatol. 2024 May 21;8(1):19. doi: 10.1186/s41927-024-00389-4.
Patients with rheumatoid arthritis (RA) are at risk of developing interstitial lung disease (ILD), which is associated with high mortality. Screening tools based on risk factors are needed to decide which patients with RA should be screened for ILD using high-resolution computed tomography (HRCT). The ANCHOR-RA study is a multi-national cross-sectional study that will develop a multivariable model for prediction of RA-ILD, which can be used to inform screening for RA-ILD in clinical practice.
Investigators will enrol consecutive patients with RA who have ≥ 2 of the following risk factors for RA-ILD: male; current or previous smoker; age ≥ 60 years at RA diagnosis; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre > 3 x upper limit of normal); presence or history of certain extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis); high RA disease activity in the prior 12 months. Patients previously identified as having ILD, or who have had a CT scan in the prior 2 years, will not be eligible. Participants will undergo an HRCT scan at their local site, which will be assessed centrally by two expert radiologists. Data will be collected prospectively on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. The primary outcomes will be the development of a probability score for RA-ILD, based on a multivariable model incorporating potential risk factors commonly assessed in clinical practice, and an estimate of the prevalence of RA-ILD in the study population. It is planned that 1200 participants will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain.
Data from the ANCHOR-RA study will add to the body of evidence to support recommendations for screening for RA-ILD to improve detection of this important complication of RA and enable early intervention.
clinicaltrials.gov NCT05855109 (submission date: 3 May 2023).
类风湿关节炎（RA）患者有发生间质性肺疾病（ILD）的风险，ILD与高死亡率相关。需要基于风险因素的筛查工具来确定哪些RA患者应使用高分辨率计算机断层扫描（HRCT）进行ILD筛查。ANCHOR-RA研究是一项多国横断面研究，将开发一个用于预测RA-ILD的多变量模型，该模型可用于指导临床实践中RA-ILD的筛查。
研究人员将招募连续的RA患者，这些患者具有以下至少2项RA-ILD风险因素：男性；当前或既往吸烟者；RA诊断时年龄≥60岁；类风湿因子高阳性和/或抗环瓜氨酸肽（滴度>正常上限的3倍）；存在或有某些RA关节外表现（血管炎、费尔蒂综合征、继发性干燥综合征、皮肤类风湿结节、浆膜炎和/或巩膜炎/葡萄膜炎）的病史；过去12个月内RA疾病活动度高。先前已确诊为ILD或在过去2年内进行过CT扫描的患者不符合条件。参与者将在当地进行HRCT扫描，由两名专家放射科医生进行集中评估。将前瞻性收集有关人口统计学和RA相关特征、患者报告的结局、合并症和肺功能的数据。主要结局将是基于包含临床实践中常用评估的潜在风险因素的多变量模型得出的RA-ILD概率评分，以及研究人群中RA-ILD患病率的估计值。计划在美国、英国、德国、法国、意大利、西班牙的约30个地点招募1200名参与者。
ANCHOR-RA研究的数据将增加证据支持RA-ILD筛查的建议，以改善对RA这一重要并发症的检测并实现早期干预。
clinicaltrials.gov NCT05855109（提交日期：2023年5月3日）。
