title: Vedolizumab induction therapy for inflammatory bowel disease in clinical practice--a nationwide consecutive German cohort study.
abstract: BACKGROUND
  Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting α4 β7 integrin.
  
  
  OBJECTIVE
  To investigate the real-world efficacy of vedolizumab for the treatment of Crohn's disease (CD) and ulcerative colitis (UC).
  
  
  METHODS
  A consecutive cohort of 212 adult IBD patients with active disease (HBI >7/partial Mayo >4) newly receiving VDZ was prospectively recruited from 7 academic and 17 community centres. The primary endpoint was clinical remission (CRM) (CD HBI ≤4, UC pMayo ≤1) in week 14. Secondary endpoints included steroid-free remission (SFCRM), clinical response (CRS) (HBI/pMayo score drop ≥3), vedolizumab impact on CRP, calprotectin and haemoglobin.
  
  
  RESULTS
  Data of 97 CD (71.1% female, HBI 11) and 115 UC (42.6% female, pMayo 6) patients were analysed. Only 5.2% CD and 24.3% UC were anti-TNFα naïve. Most had extensive mucosal involvement (Montreal L3 69.1%/E3 53.9%). At week 14, 23.7% vs. 23.5% of CD vs. UC patients achieved CRM, 19.6% vs. 19.1% SFCRM and 60.8% vs. 57.4% CRS, respectively (all based on NRI). Week 14 CRM in CD was significantly associated with no history of extraintestinal manifestations (P = 0.019), no prior adalimumab use (P = 0.011), no hospitalisation in the past 12 months (P = 0.015) and low HBI score (P = 0.02) and in UC with active or previous smoking (P = 0.044/0.028) and no anti-TNFα (P = 0.023) use. Low HBI (P = 0.019) and no hospitalisation in the past 12 months (P = 0.01) predict CD CRM. The three most common AE were joint pain, acne and nasopharyngitis.
  
  
  CONCLUSIONS
  Vedolizumab is effective in routine use.
authors.affiliation: Department of Gastroenterology and Hepatology, Charité Medical School, Humboldt-University of Berlin, Berlin, Germany.
authors.forename: D C
authors.initials: DC
authors.lastname: Baumgart
authors.affiliation: Gastroenterology Practice, Minden, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Bokemeyer
authors.affiliation: Biostatistics Consulting, Münster, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Drabik
authors.affiliation: Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), University Hospital Jena, Jena, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Stallmach
authors.affiliation: Department Internal Medicine I, University Hospital Schleswig-Holstein Campus, Kiel University of Schleswig-Holstein, Kiel, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Schreiber
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000453:epidemiology; D003424:Crohn Disease / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005858:Germany; D006801:Humans; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D011446:Prospective Studies; D012074:Remission Induction; D012907:Smoking / Q000453:epidemiology; D014409:Tumor Necrosis Factor-alpha / Q000627:therapeutic use
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D039841:Leukocyte L1 Antigen Complex; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab