Published online Jun 21, 2018. doi: 10.3748/wjg.v24.i23.2457
Peer-review started: April 18, 2018
First decision: April 27, 2018
Revised: May 6, 2018
Accepted: May 18, 2018
Article in press: May 18, 2018
Published online: June 21, 2018
The biologic antitumor necrosis factor alpha (anti-TNFα) agents have revolutionised the treatment of inflammatory bowel disease (IBD). However, some patients experience primary nonresponse, loss of response, or intolerance. Therefore, introducing a newer class of therapy with a mechanism of action that acts on different inflammatory pathways involved in IBD pathogenesis is appealing. Vedolizumab is a fully humanised monoclonal antibody that selectively targets α4β7 integrin. Based on the results of the pivotal clinical GEMINI trials, vedolizumab was approved for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) refractory or intolerant to either conventional therapy or TNFα inhibitors. This review describes the efficacy, safety, and tolerability of vedolizumab reported in both randomized, controlled, clinical trials and from real-world experience in patients with UC and CD in order to identify its place in treatment algorithms for IBD.
Core tip: Vedolizumab represents an interesting new therapeutic option for the treatment of patients with moderate-to-severe ulcerative colitis and Crohn’s disease that are refractory or intolerant to either conventional treatments or anti-TNFα agents. This review describes the efficacy, safety, and tolerability of vedolizumab demonstrated in the clinical GEMINI trials. In addition, the paper reviews the effectiveness and the safety of vedolizumab in the real-world studies in order to identify its place in treatment algorithms for patients with inflammatory bowel disease.