Risk of infection in monotherapy with tumor necrosis factor alpha inhibitor: a Meta-analysis
10.3760/cma.j.issn.1008-5734.2015.05.004
- VernacularTitle:肿瘤坏死因子α抑制剂单药疗法致感染风险的Meta分析
- Author:
Wensi LI
1
;
Qianzhou LYU
1
;
Zhangzhang CHEN
1
Author Information
1. 复旦大学附属中山医院药剂科,上海,200032
- Publication Type:Journal Article
- Keywords:
Tumor necrosis factor-alpha;
Infection;
Meta-analysis
- From:
Adverse Drug Reactions Journal
2015;17(5):334-342
- CountryChina
- Language:Chinese
-
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 ＜0.000 01].There was no significant difference in the overall incidence of infection between the test group and the positive controlled drug group [50.1％ (362/723)vs.48.3％ (320/662), RR =1.10, 95％ CI: 0.90-1.34, P =0.36].There were no significant differences in the incidence of severe infection between the test group and the placebo control group, the positive controlled drug group [1.4％ (73/5 067)vs.1.7％ (48/2 902), Peto OR =0.90, 95％ CI: 0.61-1.32, P =0.46;2.4％ (34/1 410) vs.2.8％ (28/976), RR =1.10, 95％ CI: 0.90-1.34, P =0.36].The results of subgroup analysis showed that the incidence of infection in patients who used adalimumab, or golimumab or infliximab only were significantly higher than that in the patient who used placebo [41.4％ (568/1 373) vs.39.1％ (361/923), RR =1.11,95％ CI: 1.01-1.23, P=0.04;25.5％ (397/1 558) vs.19.2％ (120/625), RR: 1.22, 95％CI: 1.02-1.45, P=0.03;38.2％ (297/777) vs.27.7％ (114/411), RR=1.35, 95％ CI: 1.13-1.61, P =0.001].There was no significant difference in the incidence of infection between the patients who used etanercept and the patients who used placebo [30.4％ (440/1 445) vs.27.9％ (278/997), RR =1.13, 95％ CI: 0.99-1.28, P =0.06].The incidence of severe infection in patients who used golimumab was significantly lower than that in the patient who used placebo [0.59％ (8/ 1 355) vs.2.12％ (11/520), Peto OR =0.21, 95％CI: 0.08-0.59, P=0.003].There were no significant differences in the incidence of severe infection between the patients who used the other 3 kinds of drugs and the patients who used placebo (all 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.
