BACKGROUND: Biological agents are emerging treatment options for the management 
of ulcerative colitis (UC).
PURPOSE: To assess the comparative efficacy and harm of biological agents in 
adult patients with moderately to severely active UC who are naive to biological 
agents.
DATA SOURCES: MEDLINE, EMBASE, and Cochrane Library from inception through 
December 2013, without language restrictions, and ClinicalTrials.gov, European 
Medicines Agency, and U.S. Food and Drug Administration Web sites.
STUDY SELECTION: Randomized, placebo-controlled or head-to-head trials assessing 
biological agents as induction or maintenance therapy for moderately to severely 
active UC.
DATA EXTRACTION: Two reviewers independently abstracted study data and outcomes 
and rated each trial's risk of bias.
DATA SYNTHESIS: There were no head-to-head trials. There were 7 double-blind, 
placebo-controlled trials that were rated as low risk of bias and showed that 
all biological agents (adalimumab, golimumab, infliximab, and vedolizumab) 
resulted in more clinical responses, clinical remissions, and mucosal healings 
than placebo for induction therapy. The results of network meta-analysis 
suggested that infliximab is more effective to induce clinical response (odds 
ratio, 2.36 [95% credible interval, 1.22 to 4.63]) and mucosal healing (odds 
ratio, 2.02 [95% credible interval, 1.13 to 3.59]) than adalimumab. No other 
indirect comparison reached statistical significance. For maintenance, 6 
double-blind, placebo-controlled trials that were rated high risk of bias showed 
that all biological agents have greater clinical efficacy than placebo. The 
occurrence of adverse events was not different between biological agents and 
placebo.
LIMITATION: Few trials, no head-to-head comparisons, and inadequate follow-up in 
maintenance trials.
CONCLUSION: Biological agents are effective treatments for UC, but head-to-head 
trials are warranted to establish the best therapeutic option.