title: Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease.
abstract: Though vedolizumab has received regulatory approval for the treatment of Crohn's disease (CD) and ulcerative colitis (UC) in adults, there is increasing off-label use in children.
  
  
  
  To describe the experience with vedolizumab in pediatric inflammatory bowel disease (IBD) patients at 3 tertiary IBD centers and examine predictors of remission.
  
  
  
  A retrospective review identified pediatric IBD patients (age < 18 yrs) receiving vedolizumab. Data on demographics, disease behavior, location, activity, and previous treatments/surgeries were collected. Disease activity was assessed using the weighted pediatric CD activity index or pediatric UC activity index. Primary outcome was week 14 remission, defined as pediatric UC activity index <10 or weighted pediatric CD activity index <12.5. Descriptive statistics and univariate analyses were performed to examine associations of clinical characteristics with efficacy.
  
  
  
  Fifty-two patients, 58% CD and 42% UC, initiated vedolizumab between June 2014 and August 2015. Median age at vedolizumab initiation was 14.9 (range 7-17) years. Ninety percent had failed ≥1 anti-tumor necrosis factor (TNF) agent. Week 14 remission rates for UC and CD were 76% and 42%, respectively (P < 0.05). Eighty percent of anti-TNF-naive patients experienced week 14 remission. At week 22, anti-TNF-naive patients had higher remission rates than TNF-exposed patients (100% versus 45%, P = 0.04). There were no infusion reactions or serious adverse events/infections.
  
  
  
  Our results suggest that vedolizumab is efficacious and safe in pediatric IBD patients, with UC patients experiencing earlier and higher rates of remission than CD patients. Anti-TNF-naive patients experienced higher remission rates than those with anti-TNF exposure. Controlled clinical trial data are needed to confirm these observations.
authors.affiliation: *Department of Pediatrics, Pediatric Inflammatory Bowel Disease Program, Cedars Sinai Medical Center, Los Angeles, California; †Department of Pediatrics, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine, Mount Sinai Hospital, New York, New York; and ‡Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, Hartford, CT; University of Connecticut School of Medicine, Farmington, Connecticut.
authors.forename: Namita
authors.initials: N
authors.lastname: Singh
authors.forename: Shervin
authors.initials: S
authors.lastname: Rabizadeh
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Jossen
authors.forename: Nanci
authors.initials: N
authors.lastname: Pittman
authors.forename: Morgan
authors.initials: M
authors.lastname: Check
authors.forename: Ghonche
authors.initials: G
authors.lastname: Hashemi
authors.forename: Becky L
authors.initials: BL
authors.lastname: Phan
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Hyams
authors.forename: Marla C
authors.initials: MC
authors.lastname: Dubinsky
mesh_terms: D000293:Adolescent; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D002648:Child; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D056687:Off-Label Use; D012074:Remission Induction; D012189:Retrospective Studies; D062606:Tertiary Care Centers; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab