Navarro-Sarabia Federico, Ariza-Ariza Rafael, Hernández-Cruz Blanca, Villanueva Isidro
Rheumatology Service, Hospital Universitario Virgen Macarena, Sevilla, Spain.
J Rheumatol. 2006 Jun;33(6):1075-81. Epub 2006 May 1.
To assess the efficacy and safety of adalimumab in the treatment of rheumatoid arthritis (RA).
A Cochrane systematic review was performed. The literature search, selection and assessment of the methodological quality of the studies, and the data extraction were performed according to the standard methodology of the Cochrane reviews. Outcome measures included American College of Rheumatology (ACR) and European League Against Rheumatism responses, Disease Activity Score 28 and components of the ACR response, and radiographic and safety data. Weighted mean difference and relative risk were used for reporting continuous and dichotomous data, respectively. Number needed to treat (NNT) or to harm (NNH) were estimated when appropriate. When significant heterogeneity was not found, data were pooled.
Six studies with 2,390 patients were included in this review. With adalimumab 40 mg every other week (eow) + methotrexate versus placebo + methotrexate, the absolute risk differences to achieve an ACR20, ACR50, and ACR70 response at 52 weeks were 35%, 32%, and 19% with NNT of 2.9, 3.1, and 5.3, respectively. At 52 weeks, adalimumab 40 mg eow and 20 mg every week (ew) significantly slowed the radiological progression. With adalimumab 40 mg eow versus placebo, the absolute risk differences to achieve an ACR20, ACR50, and ACR70 response at 24/26 weeks were 23.64%, 15.31%, and 12.22% with NNT of 5.0, 7.0, and 9.0, respectively. In most of the analyzed studies and comparisons, there were no significant differences in safety outcomes between adalimumab and control groups.
On the basis of studies reviewed here, adalimumab is efficacious in the treatment of RA. No serious adverse effects occurred.
评估阿达木单抗治疗类风湿关节炎(RA)的疗效和安全性。
进行了一项Cochrane系统评价。按照Cochrane评价的标准方法进行文献检索、研究方法学质量的选择和评估以及数据提取。结局指标包括美国风湿病学会(ACR)和欧洲抗风湿病联盟反应、疾病活动评分28以及ACR反应的组成部分,以及影像学和安全性数据。加权均数差和相对危险度分别用于报告连续性和二分性数据。在适当的时候估计治疗所需人数(NNT)或伤害所需人数(NNH)。当未发现显著异质性时,对数据进行合并。
本评价纳入了6项研究,共2390例患者。与安慰剂+甲氨蝶呤相比,每两周一次(eow)使用40mg阿达木单抗+甲氨蝶呤,在52周时达到ACR20、ACR50和ACR70反应的绝对风险差异分别为35%、32%和19%,NNT分别为2.9、3.1和5.3。在52周时,每两周一次使用40mg和每周一次使用20mg(ew)的阿达木单抗显著减缓了放射学进展。与安慰剂相比,每两周一次使用40mg阿达木单抗,在24/26周时达到ACR20、ACR50和ACR70反应的绝对风险差异分别为23.64%、15.31%和12.22%,NNT分别为5.0, 7.0和9.0。在大多数分析的研究和比较中,阿达木单抗组和对照组之间的安全性结局无显著差异。
基于此处综述的研究,阿达木单抗治疗RA有效。未发生严重不良反应。