Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Ann Rheum Dis. 2017 Jun;76(6):1113-1136. doi: 10.1136/annrheumdis-2016-210713. Epub 2017 Mar 10.
To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations.
MEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained.
The RCTs confirmed greater efficacy with a bDMARD+conventional synthetic DMARD (csDMARD) versus a csDMARDs alone (level 1A evidence). Using a treat-to-target strategy approach, commencing and escalating csDMARD therapy and adding a bDMARD in cases of non-response, is an effective approach (1B). If a bDMARD had failed, improvements in clinical response were seen on switching to another bDMARD (1A), but no clear advantage was seen for switching to an agent with another mode of action. Maintenance of clinical response in patients in remission or low disease activity was best when continuing rather than stopping a bDMARD, but bDMARD dose reduction or 'spacing' was possible, with a substantial proportion of patients achieving bDMARD-free remission (2B). RCTs have also demonstrated efficacy of several new bDMARDs and biosimilar DMARDs (1B).
This systematic literature review consistently confirmed the previously reported efficacy of bDMARDs in RA and provided additional information on bDMARD switching and dose reduction.
更新生物改善病情抗风湿药物（bDMARDs）治疗类风湿关节炎（RA）患者的疗效证据，为欧洲抗风湿病联盟（EULAR）工作组的治疗建议提供信息。
检索了 MEDLINE、EMBASE 和 Cochrane 数据库中 2013 年 1 月至 2016 年 2 月期间发表的 III 期或 IV 期（如果这些研究缺乏，则为 II 期）随机对照试验（RCT）。还获取了美国风湿病学会和 EULAR 会议的摘要。
RCT 证实，bDMARD+常规合成 DMARD（csDMARD）联合治疗比单独使用 csDMARD 更有效（1A 级证据）。采用达标治疗策略，起始并逐步增加 csDMARD 治疗，在无应答时加用 bDMARD，是一种有效的方法（1B）。如果 bDMARD 治疗失败，换用另一种 bDMARD 可改善临床应答（1A），但换用作用机制不同的药物并无明显优势。对于缓解或低疾病活动度的患者，继续使用而不是停用 bDMARD 可更好地维持临床应答，但 bDMARD 剂量减少或“间隔”是可能的，很大一部分患者可实现 bDMARD 无缓解（2B）。RCT 还证实了几种新的 bDMARD 和生物类似物 DMARD 的疗效（1B）。
本系统文献复习一致证实了 bDMARDs 在 RA 中的先前报告的疗效，并提供了关于 bDMARD 转换和剂量减少的额外信息。
