Colon polyps in patients with short bowel syndrome before and after teduglutide: Post hoc analysis of the STEPS study series. Issue 6 (June 2020)

• Record Type: Journal Article
• Authors: Armstrong, David; Forbes, Alastair; Jeppesen, Palle B.; Lee, Hak-Myung; Nagy, Peter; Seidner, Douglas L.
• Is Part Of: Clinical nutrition. Volume 39:Issue 6(2020)
• Page Start: 1774
• Page End: 1777
• Publication Date: 2020-06
• Subjects: Clinical -- Colon -- Adenoma -- Polyp -- Risk -- Surveillance; IBD inflammatory bowel disease -- NA not applicable -- NR not reported -- PBO placebo -- SBS short bowel syndrome -- SBS-IF short bowel syndrome and intestinal failure -- STEPS Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent Short Bowel Syndrome Subjects -- TED teduglutide; Critically ill -- Nutrition -- Periodicals; Diet therapy -- Periodicals; Parenteral feeding -- Periodicals; Enteral feeding -- Periodicals; Enteral Nutrition -- Periodicals; Parenteral Nutrition -- Periodicals; Metabolism -- Periodicals; Diétothérapie -- Périodiques; Alimentation parentérale -- Périodiques; Alimentation entérale -- Périodiques; Nutrition -- Périodiques; Diet therapy; Enteral feeding; Nutrition; Parenteral feeding; Electronic journals; Periodicals; Electronic journals; 615.854
• DOI: 10.1016/j.clnu.2019.08.020
• Languages: English
• ISSNs: 0261-5614

Abstract

Summary: 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. Highlights: Post hoc analysis of colon polyps in patients with SBS-IF from the 3 STEPS studies. Data from colonoscopies before and after 24–36 months treatment with teduglutide. Baseline colonoscopy detected and removed colorectal polyps in 9 (12%) patients. Colorectal polyps detected in 9 (18%) patients, 2 (22%) of whom had baseline polyps. Supports prescribing recommendations for colonoscopy before and during teduglutide.