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[659] - The Revised 2010 ACR/EULAR Diagnostic Criteria for Rheumatoid Arthritis Identify Many More Patients Who Are Eligible for Treatment and for Clinical Trials.

Vivian P Bykerk, MD, FRCPC ¹,Gilles Boire, MD, MSc²,Boulos Haraoui, MD, FRCPC³,Carol A Hitchon, MD⁴,Ed C Keystone, MD, FRCP (C)⁵,J Carter Thorne, MD, FRCPC, FACP,Diane S Ferland, RN, BSCN⁶,Janet E Pope, MD, MPH, FRCPC⁷,CATCH Investigators⁸. ¹2-005, Mt Sinai Hospital, University of Toronto, Toronto, ON,²Rheumatology Division, CHUS - Sherbrooke University, Sherbrooke, QC,³Rheumatic Disease Unit, Institut de Rhumatologie, Montreal, QC,⁴University of Manitoba, Winnipeg, MB,⁵Mt. Sinai Hospital, University of Toronto, Toronto, ON,⁶,⁷Hopital Maisonneuve Rosement, Montreal, LaSalle, QC,⁸Monsignor Roney Bldg/Rheum, St Joseph Health Care London, London, ON,⁹Canada

Background: The 2010 revised ACR/EULAR criteria for the classification of RA were developed to enable earlier diagnosis. These criteria identify patients with RA likely to have persistent and/or erosive inflammatory arthritis. The revised criteria have not been validated in North American patients or shown to identify patients who would be eligible for clinical trials that recruit for patients with a DAS28 of ≥ 3.2.
Objectives: To determine what proportion of patients with recent onset early inflammatory arthritis (IA) of < 1 year duration the revised ACR/EULAR criteria newly identify as having rheumatoid arthritis. To determine if these newly identified patients would be eligible for clinical trials in early RA.
Methods: Baseline (BL) data collected from patients (n=1146) enrolled into the Canadian Early Arthritis Cohort (CATCH) study, a multi-centre observational prospective “real world” cohort of patients with early IA recruited since July 2007 were analysed for this study. Inclusion Criteria were: age >16, symptom duration 6-52 weeks of persistent synovitis, ≥2 effused joints or 1 swollen MCP/PIP + ≥1 of: + RF, +anti-CCP, AM stiffness >45 minutes, response to NSAIDs, or a painful MTP squeeze test. The new 2010 ACR/EULAR criteria were applied to determine what proportion of patients with EIA fulfill the new criteria at BL. Most patients were treatment naive or had only received a few weeks of DMARDs. Patients newly identified as having RA by the new criteria were evaluated for disease activity and the proportion of patients with a DAS28 ≥3.2 were considered as potentially being eligible treatment of for an early RA clinical trial. Patients previously used for criteria development were excluded from this analysis.

Results: BL characteristics were: mean age 52±16 years, 73% female, median symptom duration 5.5 months, mean DAS28 ESR 4.9±1.6; 27% were initially treated with oral glucocorticoids and 50% treated with MTX. 26% (226/874) already had erosions at BL. 57% of patients were eligible for this analysis. Of the remaining 648 patients, 68% (N=441) of patients met 1987 ACR criteria for RA at BL. 31% (N=201) of patients had undifferentiated IA (UIA). Of these 74% (N=478) had a score of ≥ 6 on the new criteria. Of the 68% of patients who met old criteria, 82%(N=362) met new criteria. Of the UIA patients remaining, 57%(N=115) could now be diagnosed with RA using the new criteria. These patients had a mean (DAS28=4.0). 79% of the formerly UIA patients now meeting the new criteria had a DAS28 of ≥3.2.
Conclusions: Based on data from a Canadian cohort, revised ACR/EULAR 2010 criteria can identify a substantial number of new patients previously being designated as UIA as having RA. The majority of these patients would be eligible for clinical trials in ERA. Most of patient who fulfill the 1987 ACR criteria also fulfill the revised 2010 criteria.

新版RA分类标准发现更多需要治疗和纳入临床试验的早期关节炎患者

Bykerk VP, et al. ACR 2010. Present No: 659.

背景：制订RA分类标准(ACR/EULAR, 2010年)旨在早期诊断。这些标准能发现可能发生持续性和/或侵蚀性炎性关节炎的RA患者。新标准尚未在北美患者中得到验证，也未显示能发现符合DAS28≥3.2的临床试验纳入条件的患者。

目的：明确病程小于1年的新发早期炎性关节炎（IA）患者符合RA新标准的比例，并确定这些患者是否符合早期RA临床试验的纳入标准。

方法：加拿大早期关节炎队列（CATCH）研究是始于2007年7月的早期IA患者多中心前瞻性观察研究队列，采集此研究中1146例患者的基线期数据。本研究纳入标准为：年龄>16岁，滑膜炎持续6-52周，≥2个关节积液或1个MCP/PIP肿胀，加上以下至少一项: RF阳性，抗CCP抗体阳性，晨僵>45分钟，NSAIDs有效，疼痛MTP挤压试验阳性。采用2010年ACR/EULAR分类标准以确定基线期符合新标准的早期IA患者比例。大部分患者未经治疗或仅使用过数周DMARDs。对满足新版RA分类标准的患者进行疾病活动度评估，DAS28 ≥3.2的患者被认为可能可以参加早期RA临床试验。之前用于制订标准的患者不纳入此分析。

结果：基线期特征为：平均年龄52±16岁，73%女性，症状平均持续时间为5.5个月，平均DAS28(ESR)为4.9±1.6，27%初始使用口服糖皮质激素，50%使用MTX。26%（226/874）在基线期已有侵蚀性病变。57%患者满足本研究纳入标准。在这648例患者中，68%（N=441）患者在基线期符合RA 1987年ACR分类标准。31%（N=201）患者为未分化IA（UIA）。其中，74%患者（N=478）满足新标准积分≥ 6。在符合老标准的68%患者中，82%（N=362）符合新标准。57%的UIA患者（N=115）符合新版RA分类标准。这些患者平均DAS28为4.0。79%符合新标准的UIA患者DAS28≥3.2。

结论：根据来自加拿大队列的数据，2010年ACR/EULAR标准能在之前归为UIA的患者中发现相当一部分为RA。这些患者大部分符合早期RA临床试验的纳入标准。符合1987年ACR标准的患者大部分也符合2010年新标准。