Published online May 28, 2015. doi: 10.3748/wjg.v21.i20.6352
Peer-review started: August 28, 2014
First decision: September 15, 2014
Revised: October 14, 2014
Accepted: December 1, 2014
Article in press: December 1, 2014
Published online: May 28, 2015
AIM: To conduct a meta-analysis examining the effectiveness and safety of vedolizumab for the treatment of ulcerative colitis (UC).
METHODS: A search was conducted of MEDLINE, Cochrane, EMBASE, and Google Scholar on July 31, 2013. Inclusion criteria were: (1) Randomized controlled trial (RCT); (2) Patients treated for UC; and (3) Intervention was vedolizumab. The following information/data were extracted from studies that met the inclusion criteria: the name of the first author, year of publication, study design, patient demographic information, response rate, remission rate, and adverse events. The primary outcome was clinical response rate, and the secondary outcomes were clinical remission rate and serious adverse events. Odds ratio (OR) with 95%CI were calculated for each outcome.
RESULTS: Of 224 studies initially identified, three RCTs examining the use of vedolizumab meeting the inclusion criteria were included in the meta-analysis. All studies examined the use of vedolizumab at dosages ranging from 0.5 to 10 mg/kg body weight (one study used a standard dose of 300 mg). The follow-up periods were approximately 6 wk. The total number of patients in the intervention groups was 901, and in the control groups was 221. The mean age of the patients was approximately 41 years, and approximately half were males. The follow-up periods ranged from 43 d to 6 wk. The clinical response and remission rates were significantly higher for patients who received vedolizumab as compared to control patients (clinical response: OR = 2.69; 95%CI: 1.94-3.74, P < 0.001 and remission rate: OR = 2.72; 95%CI: 1.76-4.19, P < 0.001). Serious adverse events were not higher in patients that received vedolizumab.
CONCLUSION: This analysis supports the use of vedolizumab for the treatment of UC.
Core tip: Studies have suggested that vedolizumab may be effective in reducing intestinal inflammation in patients with ulcerative colitis (UC). This meta-analysis including three randomized controlled trials showed that treatment with vedolizumab results in significantly higher clinical response and remission rates than placebo in patients with UC. Importantly, serious adverse events were not more common in vedolizumab-treated patients than control patients. This analysis supports the use of vedolizumab for the treatment of UC.