BACKGROUND AND AIM: The aim of this systematic review was to evaluate the 
efficacy and safety of biological agents (vedolizumab, abatacept, visilizumab, 
golimumab) in patients with active moderate to severe ulcerative colitis.
METHODS: This paper was prepared according to the Preferred Reporting Items for 
Systematic Reviews and Meta-Analysis guidelines. The systematic literature 
search was performed in PubMed, Embase, Cochrane Library, and other databases 
until December 27, 2013 to identify randomized controlled trials fulfilling the 
established inclusion criteria for this review.
RESULTS: Eight randomized controlled trials were included in the systematic 
review. Vedolizumab was significantly more effective compared with placebo (P < 
0.05) increasing the percentage of patients with a clinical response, clinical 
remission and mucosal healing in the induction phase, and patients with a 
clinical remission and mucosal healing in the maintenance phase. Similarly, 
golimumab was significantly more effective than placebo (P < 0.05) regarding the 
percentage of patients with a clinical response and mucosal healing in the 
induction phase, and patients with a clinical response, clinical remission, and 
mucosal healing in the maintenance phase. The safety of these two biological 
agents was comparable with placebo during the treatment (P > 0.05). However, the 
efficacy of visilizumab or abatacept was related to the higher risk of treatment 
failure and a worse safety profile than placebo.
CONCLUSIONS: The results of the systematic review demonstrated that the efficacy 
and safety of particular biological agents are differentiated. Vedolizumab and 
golimumab occurred more effective, and comparably as safe as placebo in patients 
with active moderate to severe ulcerative colitis increasing the number of 
available therapeutic options.