| Objective:To compare the efficacy and safety outcomes of tofacitinib and infliximab in the clinical treatment of inflammatory bowel disease,and to compare the differences in different dose groups.Methods:In MEDLINE,Embase,Pubmed and other English electronic databases,the randomized controlled trials of induction and maintenance treatment of IBD compared with the placebo group of tofacitinib/infliximab were systematically searched.According to the established inclusion and exclusion criteria,literatures were screened and data were extracted.After that,Rev Man5.4 software was used for data analysis.ITC software was used to compare tofacitinib with infliximab.Results:In the 10 literatures that met the inclusion criteria,the data of 19 trial studies carried out in 2675 patients with ulcerativecolitis(UC)and 1378 patients with Crohn’s disease(CD)were statisticall y combined and anal yzed,and the results showed that:The efficacy of tofacitinib in the treatment of UC was better than that of placebo group in all aspects,including clinical response rate(2.09 [1.70-2.57]),clinical remission rate(3.35 [2.62-4.29])and mucosal healing rate(2.68 [2.16-3.32]).There was no significant difference in the rate of adverse reactions between placebo group and placebo group.The clinical response rate(2.55 [1.87-3.47])and mucosal healing rate(3.35 [2.62-4.29])were higher in the 5mg group,and the clinical remission rate(3.92 [1.60-9.59])was higher in the 15 mg group.However,the tofacitinib 10 mg group showed more stable efficacy in all aspects,and the comparison of efficacy with placebo group after 8 weeks of induction therap y also showed better clinical response rate(1.82 [1.51-2.19])and clinical response rate(3.22 [2.03-5.08]).When tofacitinib was used for CD,the clinical response rate(1.30 [1.13-1.49])was higher than that in the placebo group,but there was no statistically significant difference in the clinical response rate(1.33 [0.95-1.87])in the 15 mg group.At the same time,there was no significant difference in clinical remission rate(1.19 [0.98-1.46])and adverse reaction rate(1.01 [0.92-1.12])between groups with different doses and placebo.The clinical response rate(2.01 [1.82-2.21]),clinical remission rate(2.59 [2.22-3.03])and mucosal healing rate(1.98[1.78-2.19])in the treatment of UC b y IFX were better than those in placebo group.The incidence of adverse events was also higher in the placebo group(1.07 [1.01-1.14]).The RR values of clinical response rate,clinical remission rate and mucosal healing rate were similar between the 5mg/kg group and the10mg/kg group,indicating that the two doses could achieve similar efficacy.The clinical response rate(2.03 [1.70-2.44])and clinical remission rate(3.25 [2.30-4.59])in the IFX5mg/kg group were better than those in the placebo group after 8 weeks of induction therap y.The clinical re sponse rate(3.94 [2.03-7.62])and clinical remission rate(1.96 [1.52-2.53])in IFX treatment of CD were higher than those in placebo group.The adverse reaction rate(0.84 [0.63-1.13])was not significantly different from that of the placebo group.There were no statisticall y significant differences in the efficacy and safet y of tofacitinib and IFX in the treatment of UC among different dose groups.Tofacitinib was inferior to IFX in clinical response rate(0.33[0.168-0.648])and clinical remission rate(0.607 [0.439-0.839])when used for CD.Conclusions:Tofacitinib and infliximab have similar efficacy in the treatment of UC.However,in comparison,the tofacitinib 10 mg group had a higher rate of endoscopic mucosal healing,and a higher clinical response rat e and clinical remission rate after 8 weeks of induced therap y.Infliximab was significantl y more effective than tofacitinib in the treatment of CD.Supporting method for the treatment of UC,its itself compared with the placebo group,no obvious adverse events occur,so has a better balance in efficacy and safety;but more comprehensive studies are still needed in the clinical application of CD patients.Infliximab has good efficacy in the clinical treatment of UC and CD. |
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