Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands.
Department of Epidemiology & Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
Rheumatology (Oxford). 2017 Sep 1;56(9):1586-1596. doi: 10.1093/rheumatology/kex223.
To assess the efficacy and safety of initial COBRA-light vs COBRA therapy in RA patients after a 4-year follow-up period.
In the COBRA-light trial, 162 consecutive patients with recent-onset RA were randomized to either COBRA-light (prednisolone and MTX) or COBRA therapy (prednisolone, MTX and SSZ) for 1 year. After 1 year, treatment was continued without protocol, and adjusted by the treating physician according to clinical judgement, preferably with a treat-to-target strategy. Four years after trial initiation, all patients were invited to participate in the COBRA-light extension study, in which patients were interviewed and physically examined, patient reported outcomes were assessed, radiographs were made and clinical records were examined for comorbidities and medication use.
In the extension study, 149 out of 162 (92%) original trial patients participated: 72 COBRA-light and 77 COBRA patients. Initial COBRA-light and COBRA therapy showed similar effect on disease activity, physical functioning, radiological outcome and Boolean remission over the 4-year follow-up period. In addition, both treatment groups showed similar survival and major comorbidities, although the power to detect differences was limited. Besides protocolled differences in prednisolone, MTX and SSZ use, the use of other synthetic and biologic DMARDs and intra-articular and intramuscular glucocorticoid injections was similar in both treatment groups over the 4-year period.
Early RA patients initially treated with COBRA-light or COBRA therapy had similar efficacy and safety outcomes over a 4-year follow-up period.
评估 COBRA-light 与 COBRA 疗法在经过 4 年随访期后对 RA 患者的疗效和安全性。
在 COBRA-light 试验中，162 例近期诊断的 RA 患者被随机分为 COBRA-light（泼尼松龙和 MTX）或 COBRA 治疗（泼尼松龙、MTX 和 SSZ）组，治疗 1 年。1 年后，停止按方案治疗，由主治医生根据临床判断进行调整，最好采用达标治疗策略。试验开始 4 年后，所有患者均被邀请参加 COBRA-light 扩展研究，对患者进行访谈和体格检查，评估患者报告的结局，拍摄 X 光片，并检查临床记录以评估合并症和药物使用情况。
在扩展研究中，162 例原始试验患者中有 149 例（92%）参加：COBRA-light 组 72 例，COBRA 组 77 例。在 4 年随访期间，初始 COBRA-light 和 COBRA 治疗在疾病活动度、身体功能、影像学结果和布尔缓解方面的效果相似。此外，两组在生存和主要合并症方面也表现出相似的结果，尽管检测差异的能力有限。除了泼尼松龙、MTX 和 SSZ 使用方面的方案差异外，两组在 4 年内使用其他合成和生物 DMARDs 以及关节内和肌肉内糖皮质激素注射的情况相似。
在 4 年随访期间，最初接受 COBRA-light 或 COBRA 治疗的早期 RA 患者具有相似的疗效和安全性。
