title: Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease.
abstract: BACKGROUND
  Vedolizumab, a gut-selective, anti-inflammatory monoclonal antibody, has shown preliminary efficacy in ulcerative colitis (UC) and Crohn's disease (CD). We report long-term experience with vedolizumab for active UC and CD.
  
  
  METHODS
  After a placebo-controlled study, 38 patients with UC were randomized to a loading regimen of vedolizumab 2, 6, or 10 mg/kg on days 1, 15, and 43, followed by maintenance dosing every 8 weeks. Thirty-four vedolizumab-naive patients (15 UC; 19 CD) were randomized to vedolizumab 2, 6, or 10 mg/kg on the same schedule. Rollover patients were treated up to 630 days and treatment-naive patients were treated up to 547 days.
  
  
  RESULTS
  Seventy-two patients were dosed; 52 (72%) completed the study. In exploratory analyses, 28 of 72 (39%; UC: 21 of 53, CD: 7 of 19) achieved clinical response and 42 of 72 (58.3%; UC: 38 of 53, CD: 4 of 19) achieved clinical remission. Mean partial Mayo scores declined from baseline through day 155 in both treatment-naive patients with UC (5.4 to 1.7, respectively) and rollover patients with UC (2.3 to 1.4, respectively), leveling off thereafter. Mean Crohn's Disease Activity Index scores decreased from 295 (baseline) to 238 at day 43, continued to trend downward through day 155, and remained below baseline through day 491. Mean Inflammatory Bowel Disease Questionnaire scores increased in all treatment groups. No deaths or systemic opportunistic infections were reported.
  
  
  CONCLUSIONS
  Vedolizumab every 8 weeks for up to 78 weeks had an adverse event profile similar to that previously observed. Mean disease activity indices (partial Mayo score and Crohn's Disease Activity Index score) improved with all 3 doses investigated.
authors.affiliation: Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA.
authors.forename: Asit
authors.initials: A
authors.lastname: Parikh
authors.forename: Irving
authors.initials: I
authors.lastname: Fox
authors.forename: Timothy
authors.initials: T
authors.lastname: Leach
authors.forename: Jing
authors.initials: J
authors.lastname: Xu
authors.forename: Catherine
authors.initials: C
authors.lastname: Scholz
authors.forename: Michael
authors.initials: M
authors.lastname: Patella
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D013997:Time Factors; D014018:Tissue Distribution; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C543529:vedolizumab