OBJECTIVES: To review the pharmacology, efficacy, and safety of vedolizumab in 
the treatment of patients with ulcerative colitis (UC) and Crohn's disease (CD).
DATA SOURCES: A literature search through clinicialtrials.gov, EMBASE and 
MEDLINE was conducted (January 1966-June 2014) using the terms vedolizumab and 
MLN0002. References from retrieved articles were reviewed for any additional 
material. Additionally, the prescribing information was retrieved.
STUDY SELECTION/DATA EXTRACTION: Phase 1, 2, and 3 human and animal studies 
describing the pharmacology, pharmacokinetics, efficacy, and safety of 
vedolizumab were identified.
DATA SYNTHESIS: Vedolizumab, an α4β7 integrin inhibitor, was recently approved 
for adult patients with moderate to severe active UC or CD who are refractory or 
intolerant to standard therapies or who are dependent on corticosteroids. Trial 
data have demonstrated that vedolizumab 300 mg at weeks 0, 2, and 6 followed by 
every 8 weeks is effective at inducing and maintaining clinical response and 
remission, improving mucosal appearance, and achieving corticosteroid-free 
remission in patients with UC. This regimen is also effective at achieving 
clinical response, remission, and corticosteroid-free remission in patients with 
CD. Patients treated with vedolizumab, unadjusted for exposure, reported 
experiencing nasopharyngitis, headache, nausea, arthralgias, pyrexia, 
upper-respiratory-tract infections, fatigue, and cough.
CONCLUSIONS: Vedolizumab is an effective agent at inducing and maintaining 
remission in patients with UC or CD. Vedolizumab is generally well tolerated and 
has not been associated with progressive multifocal leukoencephalopathy.