title: Vedolizumab Effectiveness and Safety Over the First Year of Use in an IBD Clinical Practice.
abstract: OBJECTIVE
  Vedolizumab inhibits leucocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade. This agent became available in mid-2014 for the treatment of moderate to severe Crohn's disease (CD) and UC (UC). The aim of this study was to assess the patterns of use, effectiveness and safety of vedolizumab in an inflammatory bowel disease (IBD) clinical practice.
  
  
  METHODS
  Patients beginning vedolizumab were enrolled with informed consent. A prospective cohort was followed with laboratory, disease activity and quality-of-life assessments made during infusion visits up to week 14. Duration of vedolizumab use, mucosal healing and safety were analysed retrospectively for all patients not captured in the prospective component of this study.
  
  
  RESULTS
  One hundred and two patients started vedolizumab, with 51 patients (30 CD, 21 UC) followed prospectively. The CD patients exhibited a significant decrease in Crohn's Disease Activity Index (p = 0.04) and Harvey-Bradshaw index (p < 0.01) by week 14. The UC patients demonstrated improved partial Mayo scores at weeks 6 (p < 0.01) and 14 (p < 0.001). Ninety percent of all CD and UC patients remained on vedolizumab up to week 14. IBD-related quality of life was improved by week 6 in CD and UC cohorts (p = 0.02 and p < 0.01 respectively). Colectomy for lack of response and systemic histoplamosis were notable reasons for early discontinuation of vedolizumab, which was otherwise well tolerated.
  
  
  CONCLUSIONS
  Vedolizumab was efficacious and a high percentage of patients continued this therapy beyond induction dosing. Observed safety signals may be attributed to the refractory IBD disease state of this early-adopting clinical cohort.
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Emily E
authors.initials: EE
authors.lastname: Vivio
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Navya
authors.initials: N
authors.lastname: Kanuri
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Gilbertsen
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Monroe
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Neelendu
authors.initials: N
authors.lastname: Dey
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Chien-Huan
authors.initials: CH
authors.lastname: Chen
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA.
authors.forename: Alexandra M
authors.initials: AM
authors.lastname: Gutierrez
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO 63110, USA mciorba@dom.wustl.edu.
authors.forename: Matthew A
authors.initials: MA
authors.lastname: Ciorba
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C543529:vedolizumab
keywords: Entyvio; MAdCAM; clinical practice; vedolizumab