title: Safety and Efficacy of Teduglutide (Gattex) in Patients With Crohn's Disease and Need for Parenteral Support Due to Short Bowel Syndrome-associated Intestinal Failure.
abstract: BACKGROUND
  Teduglutide is a GLP-2 analogue indicated for treatment of adults with short bowel syndrome (SBS). Because of the rarity of SBS, real-world safety or efficacy data are not available in patients with Crohn's disease (CD) and SBS treated with teduglutide.
  
  
  OBJECTIVE
  To evaluate teduglutide's safety and efficacy in CD patients with SBS.
  
  
  METHODS
  We conducted a retrospective cohort study at 3 tertiary centers in the United States between 2012 and 2014. Demographic, clinical, and therapeutic data were retrieved from medical record systems.
  
  
  RESULTS
  Thirteen CD patients were included, 8 (62%) of whom were on concomitant immunosuppression. Median duration of teduglutide therapy was 365 days [interquartile range (IQR), 122 to 482 d] and 9/13 patients (69%) remain on therapy. At teduglutide initiation, 69% were on parenteral nutrition. At conclusion of follow-up, 1 patient was on parenteral nutrition. All patients were on intravenous fluids (IVF) before teduglutide; median IVF were 9000 mL/wk (IQR, 7000 to 14,000 mL/wk). IVF requirements decreased by a median of 3100 mL/wk (IQR, 2400 to 8400 mL/wk). Six patients (46%) ceased IVF. Adverse events attributed to teduglutide were obstructive symptoms (n=1), pancreatitis (n=1), asymptomatic lipase and amylase elevation (n=1), nausea (n=1), and abdominal pain (n=1). Catheter-related sepsis occurred in 4 patients.
  
  
  CONCLUSIONS
  This is the first report evaluating the safety and efficacy of teduglutide in a cohort of CD patients with SBS requiring parenteral support. More of half the cohort was on concomitant immunosuppression. Teduglutide seemed to be safe and the majority of patients were weaned off parenteral support.
authors.affiliation: *Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC †Division of Gastroenterology and Hepatology, Massachusetts General Hospital ‡Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA.
authors.forename: Bharati
authors.initials: B
authors.lastname: Kochar
authors.forename: Millie D
authors.initials: MD
authors.lastname: Long
authors.forename: Edward
authors.initials: E
authors.lastname: Shelton
authors.forename: Lorraine
authors.initials: L
authors.lastname: Young
authors.forename: Francis A
authors.initials: FA
authors.lastname: Farraye
authors.forename: Vijay
authors.initials: V
authors.lastname: Yajnik
authors.forename: Hans
authors.initials: H
authors.lastname: Herfarth
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition / Q000379:methods; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012778:Short Bowel Syndrome / Q000188:drug therapy*; D062606:Tertiary Care Centers
chemical_list: D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D010455:Peptides; C494910:teduglutide