Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Leuven, Belgium Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Leuven, Belgium.
Ann Rheum Dis. 2015 Jan;74(1):27-34. doi: 10.1136/annrheumdis-2014-205489. Epub 2014 Oct 30.
To compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial.
400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX+30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein <2.6) at W16 (intention-to-treat analysis). Secondary endpoints were good European League Against Rheumatism response, clinically meaningful health assessment questionnaire (HAQ) response and HAQ equal to zero. Adverse events (AEs) were registered.
Data from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006).
For high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile.
2008-007225-39.
比较强化联合治疗方案与糖皮质激素（GCs）在早期类风湿关节炎（eRA）治疗的前 16 周（W）内的疗效和安全性，重点关注高危患者，该研究在 Care in early RA 试验中进行。
400 名初治疾病修饰抗风湿药物（DMARD）的 eRA 患者被招募，并根据经典预后标志物分为高危或低危。高危患者（n=290）被随机分为 1/3 种治疗策略：早期类风湿关节炎联合治疗（COBRA）经典方案（甲氨蝶呤（MTX）+柳氮磺胺吡啶+60mg 泼尼松从 W7 开始逐渐减至 7.5mg 每日）、COBRA 精简方案（MTX+30mg 泼尼松从 W6 开始逐渐减至 5mg）和 COBRA 前卫方案（MTX+来氟米特+30mg 泼尼松从 W6 开始逐渐减至 5mg）。如果根据风湿病医生的判断，有必要且可行，从 W8 开始，必须进行治疗调整以达到低疾病活动度的目标。主要结局为 W16 时的缓解（28 关节疾病活动评分计算，C 反应蛋白<2.6）（意向治疗分析）。次要终点为良好的欧洲抗风湿病联盟反应、有临床意义的健康评估问卷（HAQ）反应和 HAQ 等于 0。记录不良事件（AE）。
分析了 98 例经典方案、98 例精简方案和 94 例前卫方案患者的数据。在 W16 时，经典方案、精简方案和前卫方案的缓解率分别为 70.4%、73.6%和 68.1%（p=0.713）。同样，其他次要终点也没有显示出显著差异。然而，经典方案中有 61.2%、精简方案中有 46.9%、前卫方案中有 69.1%的患者出现了与治疗相关的 AE（p=0.006）。
对于高危 eRA，MTX 联合中等剂量 GC 逐渐减量与中等或高剂量 GC 逐渐减量的 DMARD 联合治疗方案在 W16 时诱导缓解的效果一样，并且具有更有利的短期安全性。
2008-007225-39。
