title: Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study.
abstract: Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials.
  
  
  
  To determine the long-term effectiveness of vedolizumab in a real-world clinical setting.
  
  
  
  This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI ≤ 4/pMayo ≤ 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop ≥3) and steroid-free clinical remission at weeks 30 and 54.
  
  
  
  Vedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2-49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54.
  
  
  
  Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks.
authors.affiliation: Jena, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Stallmach
authors.affiliation: Jena, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Langbein
authors.affiliation: Erlangen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Atreya
authors.affiliation: Jena, Germany.
authors.forename: T
authors.identifier: 0000-0002-5576-6914
authors.initials: T
authors.lastname: Bruns
authors.affiliation: Frankfurt/Main, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Dignass
authors.affiliation: Erfurt, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Ende
authors.affiliation: Dresden, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Hampe
authors.affiliation: Frankfurt/Main, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Hartmann
authors.affiliation: Erlangen, Germany.
authors.forename: M F
authors.initials: MF
authors.lastname: Neurath
authors.affiliation: Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Maul
authors.affiliation: Berlin, Germany.
authors.forename: J C
authors.initials: JC
authors.lastname: Preiss
authors.affiliation: Dresden, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Schmelz
authors.affiliation: Berlin, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Siegmund
authors.affiliation: Frankfurt/Main, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Schulze
authors.affiliation: Leipzig, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Teich
authors.affiliation: Magdeburg, Germany.
authors.forename: U
authors.initials: U
authors.lastname: von Arnim
authors.affiliation: Berlin, Germany.
authors.forename: D C
authors.initials: DC
authors.lastname: Baumgart
authors.affiliation: Jena, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Schmidt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000378:metabolism; D003424:Crohn Disease / Q000188:drug therapy* / Q000378:metabolism; D005243:Feces / Q000737:chemistry; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D016023:Integrins / Q000037:antagonists & inhibitors / Q000276:immunology; D039841:Leukocyte L1 Antigen Complex / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D016023:Integrins; D039841:Leukocyte L1 Antigen Complex; C071777:integrin alpha4beta7; D002097:C-Reactive Protein; C543529:vedolizumab