| Background:Behcet’s disease(BD)is a chronic,multisystemic,and recurring disease characterized by relapsing oral,genital ulcers,uveitis and skin lesions.Other frequent complications include gastro-intestinal,neurologic,or vascular involvement.Intestinal BD refers to colonic ulcerative lesions documented by objective measures in patients with BD.The incidence of intestinal involvement in BD patients has ranged from 3%to 26%.Intestinal lesions associated with BD might lead to severe complications of massive gastrointestinal bleeding or perforation,which occur in 30%of intestinal BD patients and contribute mainly to the mortality of BD.However,the conventional use of treatments continues to elicit a considerable number of refractory patients unable to achieve effective relief in clinical practice.It is critical to find effective measures to control inflammation and promote healing of these lesions.As a prospective therapeutic strategy for intestinal BD,anti-tumor necrosis factor-alpha(Anti-TNF-α)agents have received increasing attention.Purpose:In this study,we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of Anti-TNF-α agents for patients with intestinal BD.Materials and Methods:PubMed,Embase,and Cochrane Library databases were searched up to July 1,2021 for studies that related to the therapy of intestinal BD by Anti-TNF-α agents.Articles that met the eligibility criteria were further assessed to extract data.The efficacy of the Anti-TNF-α agents was evaluated as the rate of patients achieving clinical remission,cured intestinal symptoms,endoscopic healing,corticosteroid discontinuation,cured non-intestinal BD symptoms and as the effect of corticosteroid reduction.The safety of the agents was assessed by the summative description of the number and severity of adverse events(AEs).Dichotomous variables were evaluated using rate as effect size and continuous variables were assessed by pooled analysis with mean differences.The pooled estimates of extracted data and their binomial 95%confidence intervals(CI)were calculated using random-effect model.We also employed I2 and Q statistics to quantify heterogeneity between studies.Subgroup analysis and sensitive analysis were used to seek the sources of heterogeneity and to assess the stability of meta-analysis results.Publication bias was assessed using the Egger’s test.All statistical analyses were conducted using the STATA 16.0 software.Results:Eleven clinical trials covering 671 patients with intestinal BD were selected for our study.According to the compositive data,pooled rate for clinical remission was 39%(95%CI 26%-52%)in patients receiving Anti-TNF-α agents.Intestinal symptoms were cured in 70%(95%CI 53%-84%)of the patients,while the rate for endoscopic healing was 65%(95%CI 52%-78%).The dose reduction of concomitant corticosteroid for every patient was 20.43 mg(95%CI 13.4mg-27.46mg).Corticosteroid discontinuation was achieved in 43%(95%CI 28%58%)of the patients and non-intestinal BD symptoms including oral aphthous ulcers,genital ulcers,ocular involvements,and skin lesions were also treated effectively.There was no significant publication bias as evidenced by Egger’s test results of all the meta-analysis.There were 239 AEs and 80 serious AEs during follow-up.The most of AEs were mild to moderate,such as infections,gastrointestinal disorders,infusion reaction and so on.Conclusion:Our study indicated that Anti-TNF-α agents may serve as an effective treatment with acceptable safety for patients with intestinal BD.However,more robust evidence from randomized controlled trials is urgently needed to assess the long-term efficacy and safety of Anti-TNF-α agents for those patients. |
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