Maksymowych Walter P, FitzGerald Oliver, Østergaard Mikkel, Homik Joanne, van der Heijde Désirée, Lambert Robert G, Elkayam Ori, Ramiro Sofia, Thorne J Carter, Larché Maggie J, Ferraccioli Gianfranco, Backhaus Marina, Burmester Gerd R, Boire Gilles, Combe Bernard, Schaeverbeke Thierry, Saraux Alain, Dougados Maxime, Rossini Maurizio, Govoni Marcello, Sinigaglia Luigi, Cantagrel Alain, Barnabe Cheryl, Bingham Clifton O, Tak Paul P, van Schaardenburg Dirkjan, Hammer Hilde Berner, Paschke Joel, Dadashova Rana, Hutchings Edna, Sepriano Alexandre, Landewé Robert
From the Departments of Medicine and Radiology, University of Alberta; CaRE Arthritis Ltd., Edmonton, Alberta; The Arthritis Program Research Group, Newmarket, Ontario; Divisions of Rheumatology and Clinical Immunology and Allergy, McMaster University, Hamilton, Ontario; Departments of Medicine and Community Health Services, Cumming School of Medicine, University of Calgary, Calgary, Alberta; Rheumatology Department, CIUSSS de l'Estrie-CHUS, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet - Glostrup, University of Copenhagen, Copenhagen, Denmark; Department of Rheumatology, Leiden University Medical Center, Leiden; Zuyderland Medical Center, Heerlen; Academic Medical Center/University of Amsterdam, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Rheumatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Divisions of Rheumatology and Internal Medicine, Catholic University of the Sacred Heart, Rome; Department of Rheumatology, Università di Verona, Verona; St. Anna Hospital, Ferrara (loc. Cona); Department of Rheumatology, Istituto Ortopedico Gaetano Pini, Milan, Italy; Department of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany; Departement de rhumatologie, Université de Montpellier, CHU Montpellier, Montpellier; Service de rhumatologie, CHU Brest, and Lymphocyte B et Autoimmunité (LBAI), U1227, Université de Brest, INSERM, F-29200 Brest; Paris Descartes University, Rheumatology Department, Cochin Hospital, AP-HP, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris; Centre de Rhumatologie, Hôpital Pierre Paul Riquet - Purpan, CHU de Toulouse, Toulouse; Service de Rhumatologie, CHU Bordeaux Pellegrin, Bordeaux, France; Divisions of Rheumatology and Allergy and Clinical Immunology, Johns Hopkins University, Baltimore, Maryland, USA; Amsterdam Rheumatology and Immunology Center, locations Reade and Amsterdam, University Medical Center, Amsterdam, the Netherlands; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
W.P. Maksymowych is Chief Medical Officer of the International Project Management Group, CaRE Arthritis Ltd.
J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.
The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.
Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.
A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor-positive or anticitrullinated protein antibody-positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.
The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956).
风湿病可溶性生物标志物工作组开展了一项国际多中心前瞻性研究——类风湿关节炎（RA）生物标志物队列研究，以获取资源用于对预测影像学进展的候选生物标志物进行临床验证。本首次报告描述了该队列、临床结局和影像学检查结果。
来自10个国家38个研究点的类风湿关节炎患者，开始或更换传统合成抗风湿药物和/或开始使用肿瘤坏死因子抑制剂后，随访2年。参与研究的医生需遵循达标治疗策略。每3个月采集生物样本（血清、尿液），每6个月对手足进行X线摄影，部分患者每3个月对手足进行超声检查。主要终点为Sharp/van der Heijde评分的影像学进展。
共招募571例患者，439例（76.9%）完成了2年随访。基线时，大多数为女性（76%），平均年龄55.7岁，平均病程6.5年。患者平均有8.4个肿胀关节和13.6个压痛关节，44关节计数疾病活动评分（DAS44）为3.8，77.7%类风湿因子阳性或抗瓜氨酸化蛋白抗体阳性。2年时达到疾病活动评分（DAS）缓解和美国风湿病学会缓解的患者比例分别为52.2%和27.1%。1年和2年时影像学进展（>0.5）的患者比例分别为38.2%和59.9%。
RA生物标志物队列前瞻性研究成功生成了大量临床、影像学（2343张X线片）和生物样本（4638份血清）资源，这些资源将用于加速鉴定和验证针对影像学损伤终点的生物标志物。（Clinicaltrials.gov：NCT01476956，clinicaltrials.gov/ct2/show/NCT01476956）
