4.4 Article

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

Journal

JOURNAL OF CLINICAL GASTROENTEROLOGY
Volume 51, Issue 6, Pages 508-511

Publisher

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/MCG.0000000000000604

Keywords

Crohn's disease; short bowel syndrome; parenteral nutrition; teduglutide; immunosuppression

Funding

  1. National Institutes of Health [T32 DK07634, 5U01DK092239, P30DK34987]
  2. NPS Pharma/Shire

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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. Aim: 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.

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