Chao Guo1, Ka Wu2, Xiaoliu Liang3, Yujia Liang3, Rong Li4. 1. Department of Pharmacy, Guigang City People's Hospital, The Eighth Affiliated Hospital of Guangxi Medical University, Guigang, Guangxi, PR China. 2. Department of Pharmacy, The Second People's Hospital of Nanning City, The Third Affiliated Hospital of Guangxi Medical University, Nanning, PR China. 3. College of Pharmacy, Guangxi Medical University, Guangxi, Nanning, 530021, PR China. 4. Guangxi Key Laboratory of Tumor Immunology and Microenvironmental Regulation, Guilin Medical University, Guilin, 541004, PR China. Electronic address: lirong1278@163.com.
Abstract
OBJECTIVE: This review aimed to evaluate the efficacy and safety of infliximab against ulcerative colitis (UC). METHODS: Collection of databases: PubMed, Cochrane Library, Medline, Embase, CBM, and CNKI. This meta-analysis included randomized controlled trials comparing infliximab vs. placebo's, steroids, or immunosuppressants. SEARCH STRATEGY: Searching terms were ('infliximab', OR 'anti-tumor necrosis factor', OR 'tumor necrosis factor', OR 'tumor necrosis factor alpha antibody', OR 'tumor necrosis factor antibody', OR 'IFX') and ('ulcerative colitis' OR 'UC'). Study quality: Independently assessed by two reviewers. DATA SYNTHESIS: Meta-analysis combined the odds ratios (OR). RESULTS: Twenty-two studies (2080 patients) evaluated infliximab therapy in UC, and the patients were randomly assigned into infliximab (1149 cases) and control groups (931 cases). The meta-analysis showed the advantage of infliximab in three endpoints (short/long-term response and long-term remission). The main outcomes considered in this meta-analysis were percentage of response (defined by the authors of each study as partial or complete symptomatic response) and remission (defined by the authors as complete symptomatic response), both at the short-term (the first control performed in the study) and the long-term (the last control performed in the study). Compared to the control group, the infliximab group was significantly more effective (short-term response: OR = 4.01, 95%CI = 3.08-5.23, p < 0.00001; long-term response: OR = 3.53, 95%CI = 2.55-4.89, p < 0.00001; long-term remission: OR = 2.80, 95%CI = 1.89-4.14, p < 0.00001; colectomy (3 months): OR = 0.38, 95%CI = 0.19-0.75, P = 0.005; colectomy (12 months): OR = 0.47, 95%CI = 0.33-0.67, p < 0.0001), but there were no significant differences in the short-term remission (OR = 1.88, 95%CI = 0.91-3.86, P = 0.09), and infliximab was notably effective in all the subgroups with different treatment doses (all p < 0.00001). In the comparison of differences in adverse effects there was no obvious difference between the two groups (OR = 0.76, 95%CI = 0.48-1.19, P = 0.23). CONCLUSION: Infliximab is more effective than placebo's, steroids, or immunosuppressants, while the drug safety between the two groups was not obvious. Further studies are necessary to confirm the long-term efficacy of infliximab in ulcerative colitis.
OBJECTIVE: This review aimed to evaluate the efficacy and safety of infliximab against ulcerative colitis (UC). METHODS: Collection of databases: PubMed, Cochrane Library, Medline, Embase, CBM, and CNKI. This meta-analysis included randomized controlled trials comparing infliximab vs. placebo's, steroids, or immunosuppressants. SEARCH STRATEGY: Searching terms were ('infliximab', OR 'anti-tumor necrosis factor', OR 'tumor necrosis factor', OR 'tumor necrosis factor alpha antibody', OR 'tumor necrosis factor antibody', OR 'IFX') and ('ulcerative colitis' OR 'UC'). Study quality: Independently assessed by two reviewers. DATA SYNTHESIS: Meta-analysis combined the odds ratios (OR). RESULTS: Twenty-two studies (2080 patients) evaluated infliximab therapy in UC, and the patients were randomly assigned into infliximab (1149 cases) and control groups (931 cases). The meta-analysis showed the advantage of infliximab in three endpoints (short/long-term response and long-term remission). The main outcomes considered in this meta-analysis were percentage of response (defined by the authors of each study as partial or complete symptomatic response) and remission (defined by the authors as complete symptomatic response), both at the short-term (the first control performed in the study) and the long-term (the last control performed in the study). Compared to the control group, the infliximab group was significantly more effective (short-term response: OR = 4.01, 95%CI = 3.08-5.23, p < 0.00001; long-term response: OR = 3.53, 95%CI = 2.55-4.89, p < 0.00001; long-term remission: OR = 2.80, 95%CI = 1.89-4.14, p < 0.00001; colectomy (3 months): OR = 0.38, 95%CI = 0.19-0.75, P = 0.005; colectomy (12 months): OR = 0.47, 95%CI = 0.33-0.67, p < 0.0001), but there were no significant differences in the short-term remission (OR = 1.88, 95%CI = 0.91-3.86, P = 0.09), and infliximab was notably effective in all the subgroups with different treatment doses (all p < 0.00001). In the comparison of differences in adverse effects there was no obvious difference between the two groups (OR = 0.76, 95%CI = 0.48-1.19, P = 0.23). CONCLUSION:Infliximab is more effective than placebo's, steroids, or immunosuppressants, while the drug safety between the two groups was not obvious. Further studies are necessary to confirm the long-term efficacy of infliximab in ulcerative colitis.