Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure
- PMID: 38873891
- DOI: 10.1002/jpn3.12276
Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure
Abstract
Objectives: Patients with short bowel syndrome-associated intestinal failure (SBS-IF) require long-term parenteral nutrition and/or intravenous fluids (PN/IV) to maintain fluid or nutritional balance. We report the long-term safety, efficacy, and predictors of response in pediatric patients with SBS-IF receiving teduglutide over 96 weeks.
Methods: This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF. Endpoints included treatment-emergent adverse events (TEAEs) and clinical response (≥20% reduction in PN/IV volume from baseline). A multivariable linear regression identified predictors of teduglutide response; the dependent variable was mean change in PN/IV volume at each visit over 96 weeks.
Results: Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies. Most TEAEs were moderate or severe in intensity in both groups. By week 96, 82.1% of patients from the any TED group achieved a clinical response, with a mean fluid decrease of 30.1 mL/kg/day and an energy decrease of 21.6 kcal/kg/day. Colon-in-continuity, non-White race, older age at baseline, longer duration of teduglutide exposure, and increasing length of remaining small intestine were significantly associated with a reduction in mean PN/IV volume requirements.
Conclusions: In pediatric patients with SBS-IF, teduglutide treatment resulted in long-term reductions in PN/IV requirements. The degree of PN/IV volume reduction depended on the duration of teduglutide exposure, underlying bowel anatomy, and demographics.
Keywords: Gattex; Revestive; glucagon‐like peptide‐2; parenteral nutrition; pediatrics.
© 2024 Takeda Pharmaceuticals U.S.A., Inc. Journal of Pediatric Gastroenterology and Nutrition published by Wiley Periodicals LLC on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
References
REFERENCES
-
- Goulet O, Abi Nader E, Pigneur B, Lambe C. Short bowel syndrome as the leading cause of intestinal failure in early life: some insights into the management. Pediatr Gastroenterol Hepatol Nutr. 2019;22(4):303‐329.
-
- Drucker DJ, Yusta B. Physiology and pharmacology of the enteroendocrine hormone glucagon‐like peptide‐2. Annu Rev Physiol. 2014;76:561‐583.
-
- Tavares W, Drucker DJ, Brubaker PL. Enzymatic‐ and renal‐dependent catabolism of the intestinotropic hormone glucagon‐like peptide‐2 in rats. American J Physiol Endocrinol Metabol. 2000;278(1):E134‐E139.
-
- Drucker DJ, Shi Q, Crivici A, et al. Regulation of the biological activity of glucagon‐like peptide 2 in vivo by dipeptidyl peptidase IV. Nat Biotechnol. 1997;15(7):673‐677.
-
- Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143(6):1473‐1481.e3.
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Miscellaneous