| [2108] - Predictive Validity of the New Preliminary ACR/EULAR Definitions for Remission in Rheumatoid Arthritis.
David T Felson, MD, MPH 1,Josef S Smolen, MD2,George A Wells, MSc, PhD3,Bin Zhang, DSc4,Lilian HD van Tuyl, PhD5,Julia Funovits6,Maarten Boers, MD, PhD, MSc7,for the ACR/EULAR commission to redefine remission in rheumatoid arthritis. 1Clinical Research Training Unit, Boston University School of Medicine, Boston, MA,22nd Department of Medicine, Krankenhaus Lainz, Vienna,3Epidemiology & Community Med, Univ of Ottawa Faculty of Med, Ottawa, ON,4Clinical Epidemiology Research, Boston Univ Schl of Medicine, Boston, MA,5VU university medical center, Amsterdam,6Medical University of Vienna,7Epidemiology & Biostatistics, VU Univ Medical Center PK6Z165, Amsterdam,8
Background: With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials.
Methods: A committee constituted from members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology (OMERACT) Initiative guided the process and reviewed prespecified analyses from clinical trials of patients with RA. A stringent definition was requested including at least joint counts and an acute phase reactant, but excluding duration of state. As part of the search for a remission definition, trial data were analyzed to examine the ability of candidate measures to predict later good x-ray and functional outcomes (defined as change ≤0 in van der Heijde/Sharp scores and Health Assessment Questionnaire (HAQ) change ≤0 and HAQ score consistently ≤0.5 both during the 2nd year of respective trials). Likelihood ratios compared the proportion of patients in remission having the good outcome to the proportion of patients not in remission having the good outcome. To rank candidate definitions of remission, the p value from the logistic regression chi square test were used.
Candidate definitions of remission were downgraded when they led to values of core set measures which suggested disease activity incompatible with remission.
Results: Patients in a state of remission by several of the Boolean candidate definitions, as well as by traditional SDAI (≤3.3) and CDAI (≤2.8) definitions had an increased likelihood of both x-ray and HAQ stability (see Table 1). | ACR/EULAR关于RA缓解的新定义的预测效度 Felson DT, et al. ACR 2010. Present No: 2108. 背景：缓解日渐成为RA的治疗目标，暂无一种广泛使用的定义既严格、又可达到，而且可以标准化应用于临床研究。 方法：由ACR、EULAR、风湿病结局评估（OMERACT）成员组成的委员会指导相关研究过程，并评估RA临床试验的既定分析。严格定义至少需要包括关节计数和急性期反应物，但需排除状态持续时间。在搜索缓解定义时，分析试验数据，以研究候选方法对后期X线和功能结局的预测能力（在各试验的第2年，van der Heijde/Sharp评分中定义为变化≤0，HAQ变化≤0且HAQ评分持续≤0.5）。比较缓解且结局良好的患者比例与未缓解但结局良好的患者比例的似然比。为了将缓解的候选定义进行分级，采用Logistic回归卡方检验的p值作为评级参数。 当核心组评价值提示疾病活动度与缓解矛盾时，该候选定义降级。 结果：由数个Boolean候选定义以及传统SDAI（≤3.3）和CDAI（≤2.8）所定义的临床缓解状态的患者，其获得X线以及HAQ稳定态的似然性高（见表1）。 |
| However, reaching remission according to DAS28, both at the traditional (<2.6) and a more stringent cut point (<2.0), was associated only with the likelihood of HAQ stability but not x-ray stability. Additional definitions were tested, including definitions that incorporated pain or patient global at remission levels and other variations, and results were similar. Apart from the DAS28 result, the analyses did not help to distinguish between definitions.
Conclusion: Based on these and other considerations, we propose that a patient be defined as in remission based on one of two definitions of remission: 1: When their scores on the following measures are all ≤1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI ≤3.3.
These new definitions can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be prespecified in each trial as an outcome and that the results of both be reported. These definitions are currently 'preliminary' and are pending approval from the ACR and EULAR boards.
| 然而，DAS28临床缓解（传统<2.6，更严格<2.0）仅与HAQ稳定相关，而与X线稳定无关。对其它定义进行检验，包括含有疼痛、患者对缓解的总体评估及其他参数的定义，结果类似。除DAS28之外，各种分析无法区分不同的定义。 结论：基于上述及其它考虑，我们建议采用以下两种缓解定义：第一种，下列几项评分均≤1：压痛关节数，肿胀关节数，CRP（计量单位用mg/dL），患者总体评分（0-10分）；或者第二种，SDAI≤3.3。 这些新定义可以被广泛、一致地应用于RA临床试验。我们建议各试验将其中一种定义预设为观察结局，并报告两种定义的结果。 这些定义目前为“初步”定义，有待ACR和EULAR委员会审批。 |
