Khanna Dinesh, Oh MyungShin, Furst Daniel E, Ranganath Veena, Gold Richard H, Sharp John T, Park Grace S, Keystone Edward C, Paulus Harold E
Division of Immunology, Department of Medicine, University of Cincinnati and the Veterans Affairs Medical Center, Cincinnati, Ohio 45267-0563, USA.
Arthritis Rheum. 2007 Apr 15;57(3):440-7. doi: 10.1002/art.22619.
To evaluate published proposed definitions of minimal disease activity (MDA) and remission in patients with early rheumatoid arthritis (RA).
The cohort comprised disease-modifying antirheumatic drug (DMARD)-naive patients with early seropositive active RA (n = 200) treated with traditional DMARDs in the prebiologic era. MDA definitions included Disease Activity Score in 28 joints (DAS28) <or=2.85, or achieving 5 of 7 World Health Organization (WHO)/International League of Associations for Rheumatology (ILAR) core set measure thresholds as proposed by the Outcome Measures in Rheumatology Clinical Trials. Other MDA definitions included Simplified Disease Activity Index (SDAI) score <or=11 and Clinical Disease Activity Index (CDAI) score <or=10. Remission definitions included American College of Rheumatology (ACR) remission, DAS28 <2.6, DAS28 <2.4, achieving all 7 WHO/ILAR core set measure thresholds, SDAI <or=3.3, and CDAI <or=2.8. Physical function was assessed using the Health Assessment Questionnaire (HAQ) disability index (DI) and radiographic progression was assessed using the Sharp score.
At baseline, no patients were in MDA or remission. Depending on the MDA definition, 20-32%, 27-32%, and 30-48% were in MDA at 6, 12, and 24 months, respectively. Depending on the remission definition, 0.7-15%, 0-24%, and 0-33% were in remission at 6, 12, and 24 months, respectively. For example, at 6 months, lowest (highest) responses for MDA were seen with DAS28 <or=2.85 (SDAI <or=11) and for remission with ACR remission criteria (DAS28 <2.6). Patients who achieved either MDA or remission had lower HAQ DI and radiographic scores compared with patients who achieved neither.
Our study demonstrated that different proportions of patients were classified as MDA or remission depending on the definition used. This has implications in predefining MDA or remission for a clinical trial or to establish goals for optimum management of RA in clinical practice.
评估已发表的早期类风湿关节炎(RA)患者最小疾病活动度(MDA)和缓解的定义。
该队列包括在生物制剂时代之前接受传统改善病情抗风湿药(DMARD)治疗的初治血清阳性活动性早期RA患者(n = 200)。MDA定义包括28个关节疾病活动评分(DAS28)≤2.85,或达到风湿病临床试验疗效指标中提出的7项世界卫生组织(WHO)/国际风湿病联盟(ILAR)核心指标中的5项阈值。其他MDA定义包括简化疾病活动指数(SDAI)评分≤11和临床疾病活动指数(CDAI)评分≤10。缓解定义包括美国风湿病学会(ACR)缓解、DAS28<2.6、DAS28<2.4、达到所有7项WHO/ILAR核心指标阈值、SDAI≤3.3和CDAI≤2.8。使用健康评估问卷(HAQ)残疾指数(DI)评估身体功能,使用Sharp评分评估影像学进展。
在基线时,没有患者处于MDA或缓解状态。根据MDA定义,分别有20 - 32%、27 - 32%和30 - 48%的患者在6、12和24个月时处于MDA状态。根据缓解定义,分别有0.7 - 15%、0 - 24%和0 - 33%的患者在6、12和24个月时处于缓解状态。例如,在6个月时,MDA的最低(最高)应答率分别见于DAS28≤2.85(SDAI≤11),缓解的最低(最高)应答率分别见于ACR缓解标准(DAS28<2.6)。与既未达到MDA也未达到缓解的患者相比,达到MDA或缓解的患者HAQ DI和影像学评分更低。
我们的研究表明,根据所使用的定义,不同比例的患者被分类为MDA或缓解。这对于在临床试验中预先定义MDA或缓解或在临床实践中为RA的最佳管理制定目标具有重要意义。