Machado Marina Amaral de Ávila, Maciel Alessandra Almeida, de Lemos Lívia Lovato Pires, Costa Juliana Oliveira, Kakehasi Adriana Maria, Andrade Eli Iola Gurgel, Cherchiglia Mariangela Leal, Acurcio Francisco de Assis
Rev Bras Reumatol. 2013 Sep-Oct;53(5):419-30.
Since the discovery of the role of tumor necrosis factor in the physiopathological process of rheumatoid arthritis, five drugs that block this cytokine have been used as therapeutic options. To evaluate the efficacy and safety of adalimumab in the treatment of rheumatoid arthritis we performed a systematic review and meta-analysis of randomized controlled trials. A search of relevant studies in Medline (through PubMed) and LILACS in June 2011 was carried out. Study selection, data collection and analysis were performed in pairs and independently by two reviewers and by a third reviewer in cases of disagreement. The meta-analysis was performed using the software Review Manager® 5.1 using the random effects model. Eleven articles related to adalimumab were included and considered nine studies with 3461 patients. Ten studies showed low risk of bias regarding the blinding of participants and personnel and blinding of outcome assessment. Patients who received the combination treatment of adalimumab and methotrexate showed better efficacy results and lower radiographic progression when compared to placebo + methotrexate in 24-104 weeks. Patients who received adalimumab as monotherapy showed better efficacy outcomes when compared to placebo in 24 and 26 weeks. The results of the meta-analyses of adverse events were not statistically significant, except for reactions at the injection site, which favored the control group. Adalimumab efficacy was demonstrated in monotherapy and when associated to a DMARD, but the evidence for combined use is more robust.
自从发现肿瘤坏死因子在类风湿性关节炎病理生理过程中的作用以来，已有五种阻断该细胞因子的药物被用作治疗选择。为了评估阿达木单抗治疗类风湿性关节炎的疗效和安全性，我们对随机对照试验进行了系统评价和荟萃分析。2011年6月在Medline（通过PubMed）和拉丁美洲及加勒比地区卫生科学数据库（LILACS）中检索了相关研究。研究选择、数据收集和分析由两名审阅者成对独立进行，如有分歧则由第三名审阅者进行。荟萃分析使用Review Manager® 5.1软件，采用随机效应模型。纳入了11篇与阿达木单抗相关的文章，共9项研究，涉及3461例患者。10项研究显示，在参与者和人员的盲法以及结果评估的盲法方面，偏倚风险较低。在24至104周内，与安慰剂+甲氨蝶呤相比，接受阿达木单抗与甲氨蝶呤联合治疗的患者显示出更好的疗效结果和更低的影像学进展。在24周和26周时，接受阿达木单抗单药治疗的患者与安慰剂相比显示出更好的疗效结果。除注射部位反应外，不良事件的荟萃分析结果无统计学意义，注射部位反应更有利于对照组。阿达木单抗在单药治疗以及与改善病情抗风湿药联合使用时均显示出疗效，但联合使用的证据更为充分。
