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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • David Armstrong
  • Alastair Forbes
  • Palle B Jeppesen
  • Hak-Myung Lee
  • Peter Nagy
  • Douglas L Seidner
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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.

OriginalsprogEngelsk
TidsskriftClinical Nutrition
Vol/bind39
Udgave nummer6
Sider (fra-til)1774-1777
Antal sider4
ISSN0261-5614
DOI
StatusUdgivet - jun. 2020

Bibliografisk note

Funding Information:
Shire is a member of the Takeda group of companies. The funding for this post hoc analysis was provided by Shire International GmbH , Zug, Switzerland. Under the direction of the authors and funded by Shire, editorial support and writing assistance by Maryann T. Travaglini, PharmD, was provided by Complete Healthcare Communications, LLC, a CHC Group company (North Wales, PA, USA).

ID: 59434347