Hochberg M C, Tracy J K, Hawkins-Holt M, Flores R H
Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD 21201 USA.
Ann Rheum Dis. 2003 Nov;62 Suppl 2(Suppl 2):ii13-6. doi: 10.1136/ard.62.suppl_2.ii13.
To determine, using the method of adjusted indirect comparisons, whether there are differences in efficacy of tumour necrosis factor (TNF alpha) blocking agents, as measured by the rate ratios for American College of Rheumatology (ACR) 20, 50, and 70 responses, in patients with rheumatoid arthritis with an incomplete response to methotrexate.
A systematic review was performed to identify placebo controlled trials of 24-30 weeks' duration of combination therapy that used a step-up approach with the addition of TNF alpha blocking agents to methotrexate. The method of "adjusted indirect comparisons" was used to compare results across trials to determine the relative risk for an ACR20 or 50 response.
Placebo controlled trials for adalimumab, etanercept, and infliximab provided data on ACR20 and 50 responses. Both the similarity of demographic and disease characteristics of patients at entry, and the homogeneity of response rates in the placebo groups across trials, suggested that comparing results across trials was valid. The relative risk for obtaining an ACR20 and 50 response derived from the adjusted indirect comparisons of the TNF alpha blocking agents did not significantly differ from unity.
The analysis showed that the three currently marketed TNF alpha blocking agents have similarly efficacy when added to methotrexate in the treatment of patients with rheumatoid arthritis with active disease.
采用调整后的间接比较方法,确定在对甲氨蝶呤反应不完全的类风湿关节炎患者中,以美国风湿病学会(ACR)20、50和70反应率为衡量指标,肿瘤坏死因子(TNFα)阻断剂的疗效是否存在差异。
进行一项系统评价,以识别采用逐步加量方法在甲氨蝶呤基础上加用TNFα阻断剂的24 - 30周联合治疗的安慰剂对照试验。采用“调整后的间接比较”方法比较各试验结果,以确定ACR20或50反应的相对风险。
阿达木单抗、依那西普和英夫利昔单抗的安慰剂对照试验提供了ACR20和50反应的数据。入组患者的人口统计学和疾病特征的相似性,以及各试验中安慰剂组反应率的同质性,表明比较各试验结果是有效的。通过对TNFα阻断剂进行调整后的间接比较得出的获得ACR20和50反应的相对风险与1无显著差异。
分析表明,在治疗活动性类风湿关节炎患者时,目前上市的三种TNFα阻断剂在加用甲氨蝶呤时疗效相似。