Abstract
Objective To evaluate the risk of infection in monotherapy of tumor necrosis factor alpha (TNF-α) inhibitor. Methods The database of Pubed, Embase, Cochrane library, and Web with Science were searched from the inception to November, 2014. The literatures of randomized controlled trials in English which included reports that only used TNF-α inhibitor (the test group) and placebo or positive controlled drug (the control group)were selected. The methodological quality of the literatures which enrolled into the study were assessed by Jadad scale (inferior quality: <3 points, high quality: 3-5 points). The software RevMan 5.2 was used for Meta-analysis. The infection rate and the severe infection rate were expressed by relative risk (RR), Peto odds ratio (Peto OR)and 95% confidence interval (CI). Results A total of 33 trials presented by 32 reports, and 11 819 patients (7 408 cases in the test group using adalimumab or golimumab or infliximab or etanercept, respectively, and 4 411 cases in the control group using placebo, positive control drug such as methotrexate or salazosulfapyridine, respectively )were enrolled into the Meta-analysis. The Jadad scores of the 33 trials were all≥3 points. The results of the Meta-analysis showed that the overall total incidence of infection in patients who used TNF-α inhibitors only was higher than that in the patients who used placebo [33.03% (1 702/5 153) vs.29.53%(873/2 956), RR=1.17, 95%CI: 1.09-1.25, P 0.05). Conclusions The monotherapy with TNF-α inhibitor may increase the overall incidence of infection, but will not increase the incidence of severe infection. The monotherapy with TNF-α inhibitor is relatively safety in clinical practice. Key words: Tumor necrosis factor-alpha; Infection; Meta-analysis
Published Version
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