Objective: To pool the data of studies and evaluate the efficacy and safety of TNFα blocking agents in the treatment of ulcerative colitis (UC).
Methods: The randomized clinical trials (RCT) that compared the efficacy or safety of TNFα in the treatment of UC were researched from Pubmed, OVID, EMBASE, Cochrane library, CNKI, Wanfang data and VIP Chinese Scientific and Technologic Periodical Database. Statistical heterogeneity between trials was evaluated by Revman 5.0 and was considered to exist when P < 0.1. Heterogeneity of the included articles was tested, which was used to select proper effect model to calculate. Publication bias was investigated through visual inspection of funnel plots.
Results: Nine RCT including 1226 cases were analyzed. Eight hundred and six cases had received TNFα treatment and 420 cases had received placebo or glucocorticoid treatment. Compared with placebo or glucocorticoid groups, TNFα group achieved significantly higher rates of short-term clinical response, short-term clinical remission, long-term clinical response, long-term clinical remission and the total OR were 2.36 (95%CI 1.34 - 4.15), 2.42 (95%CI 1.22 - 4.81), 3.22 (95%CI 2.28 - 4.55) and 2.82 (95%CI 1.91 - 4.16) respectively. TNFα group was less likely to undergo colectomy than placebo group and the total OR was 0.31 (95%CI 0.20 - 0.48). TNFα could not improve the mucosal healing and quality of life. No significant difference was found in adverse effect between TNFα group and placebo or glucocorticoid group (OR = 1.07 (95%CI 0.55 - 2.09, P = 0.84)). The rate of serious adverse effect in TNFα group was less than placebo or glucocorticoid groups (OR = 0.65, 95%CI 0.48 - 0.89, P = 0.007). Inspection of the funnel plots for all dichotomous data measures had not revealed evidence of publication bias.
Conclusions: Patients with moderately to severely active UC treated with TNFα have effective clinical response and clinical remission and are less likely to undergo colectomy than those receiving placebo or glucocorticoid. TNFα treatment is safe for UC but can not improve the mucosal healing and quality of life. Large-scale, high-quality RCTs are needed to confirm or refuse the available evidence.