title: Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn's Disease Patients Stratified by Age.
abstract: The efficacy and safety of vedolizumab, a gut-selective α4β7integrin antibody, were demonstrated in the GEMINI 1 and GEMINI 2 clinical trials of adults aged 18-80 years. We investigated the efficacy and safety of vedolizumab in patients stratified by age from the GEMINI trials.
  
  
  
  Safety and efficacy, including clinical response, clinical remission, and corticosteroid-free remission, at week 6 and/or 52 were determined post hoc in patients aged <35, 35 to <55, and ≥55 years.
  
  
  
  At baseline, 353, 412, and 130 ulcerative colitis (UC) and 582, 443, and 90 Crohn's disease (CD) patients were aged <35, 35 to <55, and ≥55. Of these patients, 56 were aged ≥65 years (UC: 33, CD: 23). Trends favoring vedolizumab over placebo were observed for most efficacy endpoints irrespective of patient age; some variability between subgroups was observed. Safety profiles of vedolizumab and placebo were similar in all age groups. Vedolizumab-treated patients aged ≥55 had the lowest incidence of serious infections (0.9 per 100 person-years) and adverse events leading to hospitalization (14.8 per 100 person-years). There were no age-related differences in the incidence of adverse hematological events, malignancy, or death.
  
  
  
  The safety and efficacy of vedolizumab in patients with UC or CD were similar for all age groups. The number of patients in the oldest age group in these analyses was small; thus further studies of vedolizumab in larger cohorts of elderly patients are warranted.
  
  
  
  Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.).
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. VYAJNIK@mgh.harvard.edu.
authors.forename: Vijay
authors.initials: V
authors.lastname: Yajnik
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Nabeel
authors.initials: N
authors.lastname: Khan
authors.affiliation: Mount Sinai Hospital, New York, NY, USA.
authors.forename: Marla
authors.initials: M
authors.lastname: Dubinsky
authors.affiliation: Toronto Digestive Disease Associates, University of Toronto, Toronto, Canada.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Axler
authors.affiliation: Takeda Development Centre Europe Ltd, London, UK.
authors.forename: Alexandra
authors.initials: A
authors.lastname: James
authors.affiliation: Takeda Development Centre Europe Ltd, London, UK.
authors.forename: Brihad
authors.initials: B
authors.lastname: Abhyankar
authors.affiliation: Takeda Pharmaceuticals U.S.A. Inc, Deerfield, IL, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Lasch
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D016903:Drug Monitoring / Q000379:methods; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D016023:Integrins / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D016023:Integrins; C071777:integrin alpha4beta7; C543529:vedolizumab
keywords: Crohn’s disease; Ulcerative colitis; Vedolizumab