Choi Miyoung, Hyun Min Kyung, Choi Seongmi, Tchoe Ha Jin, Lee Sung Yeon, Son Kyeong Min, Kim Min-Jeong, Jung Young Ok, Kim Hyun Ah
National Evidence-Based Healthcare Collaboration Agency (NECA), Seoul, Korea.
Department of Preventive Medicine, Dongguk University College of Korean Medicine, Seoul, Korea.
Korean J Intern Med. 2017 May;32(3):536-547. doi: 10.3904/kjim.2015.135. Epub 2016 Jun 2.
BACKGROUND/AIMS: Biological agents (biologics) targeting proinflammatory signaling have emerged as an important treatment option in rheumatoid arthritis (RA). Despite the clinical effectiveness of biologics for patients with RA who do not respond to 'traditional' disease-modifying anti-rheumatic drugs (DMARDs), there are concerns regarding their cost and long-term safety. In this study, we aimed to compare the efficacy of various biologics and traditional DMARDs in RA patients refractory to methotrexate (MTX).
Four DMARDs (hydroxychloroquine, sulfasalazine, MTX, lef lunomide) and five anti-tumor necrosis factor drugs (adalimumab, etanercept, golimumab, inf liximab, and certolizumab) were selected. A systematic search of published studies was performed from inception through July 2013. Randomized trials of adults with MTX-refractory RA comparing two or more of the selected medications were included. Among 7,938 titles identified, in total, 16 head-to-head trials were selected. Two reviewers independently abstracted the study data and assessed methodological quality using the Cochrane Risk of Bias. Comparative efficacy was analyzed using a Bayesian mixed treatment comparison (MTC).
In total, 9, 4, and 11 studies were included for the outcome measures of the Health Assessment Questionnaire (HAQ), Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) < 2.6 (remission), and American College of Rheumatology (ACR) 70 response, respectively. The treatments with the highest efficacy for each outcome measure were certolizumab combined with MTX, golimumab combined with MTX, and certolizumab combined with MTX, respectively.
Based on MTC analysis, using data from published randomized controlled trials, certolizumab and golimumab combined with MTX showed the highest efficacy in the three outcome measures (HAQ, DAS28-ESR < 2.6, and ACR 70 response) in MTX-refractory RA patients.
背景/目的：靶向促炎信号传导的生物制剂已成为类风湿关节炎（RA）的一种重要治疗选择。尽管生物制剂对那些对“传统”改善病情抗风湿药物（DMARDs）无反应的RA患者具有临床疗效，但人们对其成本和长期安全性仍存在担忧。在本研究中，我们旨在比较各种生物制剂和传统DMARDs对甲氨蝶呤（MTX）难治的RA患者的疗效。
选择了四种DMARDs（羟氯喹、柳氮磺吡啶、MTX、来氟米特）和五种抗肿瘤坏死因子药物（阿达木单抗、依那西普、戈利木单抗、英夫利昔单抗和赛妥珠单抗）。从研究开始到2013年7月进行了已发表研究的系统检索。纳入了比较两种或更多所选药物的成年MTX难治性RA的随机试验。在识别出的7938篇文献中，总共选择了16项直接比较试验。两名研究者独立提取研究数据，并使用Cochrane偏倚风险评估方法学质量。使用贝叶斯混合治疗比较（MTC）分析比较疗效。
分别有9项、4项和11项研究纳入了健康评估问卷（HAQ）、疾病活动评分28-红细胞沉降率（DAS28-ESR）<2.6（缓解）和美国风湿病学会（ACR）70反应的疗效评估。每种疗效评估中疗效最高的治疗分别是赛妥珠单抗联合MTX、戈利木单抗联合MTX和赛妥珠单抗联合MTX。
基于MTC分析，使用已发表的随机对照试验数据，赛妥珠单抗和戈利木单抗联合MTX在MTX难治的RA患者的三项疗效评估（HAQ、DAS28-ESR<2.6和ACR 70反应）中显示出最高疗效。
