Colon polyps in patients with short bowel syndrome before and after teduglutide: post hoc analysis of the STEPS study series

Armstrong, David, Forbes, Alastair ORCID: https://orcid.org/0000-0001-7416-9843, Jeppesen, Palle Bekker, Lee, Hak-Myung, Nagy, Peter and Seidner, Douglas L. (2020) Colon polyps in patients with short bowel syndrome before and after teduglutide: post hoc analysis of the STEPS study series. Clinical Nutrition, 39 (6). pp. 1774-1777. ISSN 0261-5614

[thumbnail of Accepted_Manuscript]
Preview
PDF (Accepted_Manuscript) - Accepted Version
Available under License Creative Commons Attribution Non-commercial No Derivatives.

Download (1MB) | Preview
[thumbnail of Proof]
Preview
PDF (Proof)
Available under License Creative Commons Attribution Non-commercial No Derivatives.

Download (250kB) | Preview

Abstract

Background & aims: Teduglutide promotes intestinal growth and is approved for the treatment of short bowel syndrome and intestinal failure (SBS-IF). Based on the pharmacologic activity and preclinical findings, teduglutide can potentially induce proliferative colonic mucosal changes. The aim of this study is to report the occurrence of colorectal polyps in adult patients with SBS-IF who received teduglutide in clinical studies conducted to date. Methods: A post hoc analysis of the completed Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent Short Bowel Syndrome Subjects (STEPS) clinical study series (NCT00798967, EudraCT 2008-006193-15; NCT00930644, EudraCT 2009-011679-65; NCT01560403) evaluated electronic case report form data for baseline colonoscopies (performed before treatment) and for surveillance or end-of-study (performed after treatment with teduglutide 0.05 mg/kg/day for 24 and 36 months) post-exposure procedures. Results: In the STEPS studies, 73 patients treated with teduglutide had a baseline colonoscopy. No post-exposure colonoscopy was scheduled in STEPS. In STEPS-2/3, 50 of 65 patients with remnant colon (77%) underwent a protocol-mandated post-exposure colonoscopy. Colon polyps were reported at baseline in 12% (9/73) of patients and post-exposure in 18% (9/50) of patients. Two had polyps both at baseline and post-exposure. On histology, available for 7 patients, 5 had adenomas (1 serrated, 4 tubular) and none had malignancy or high-grade dysplasia. Conclusion: These data support recommendations for colonoscopic screening before teduglutide therapy and subsequent on-therapy colonoscopic surveillance for patients with SBS-IF. Further studies are required to assess the risk of polyp formation in patients with SBS-IF and the most appropriate colon polyp surveillance strategies.

Item Type: Article
Uncontrolled Keywords: adenoma,clinical,colon,polyp,risk,surveillance,nutrition and dietetics,critical care and intensive care medicine ,/dk/atira/pure/subjectarea/asjc/2900/2916
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Nutrition and Preventive Medicine
Faculty of Medicine and Health Sciences > Research Groups > Gastroenterology and Gut Biology
Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 20 Aug 2019 08:30
Last Modified: 20 Apr 2023 08:31
URI: https://ueaeprints.uea.ac.uk/id/eprint/72014
DOI: 10.1016/j.clnu.2019.08.020

Downloads

Downloads per month over past year

Actions (login required)

View Item View Item