LB054 - PREGNANCY OUTCOMES IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE TREATED WITH TEDUGLUTIDE: RESULTS FROM A GLOBAL, PROSPECTIVE, MULTICENTRE REGISTRY

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LB054

PREGNANCY OUTCOMES IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE TREATED WITH TEDUGLUTIDE: RESULTS FROM A GLOBAL, PROSPECTIVE, MULTICENTRE REGISTRY

F. Joly1,*, Y. W. Huang2, J. P. Allard3, G. E. Gondolesi4, P. B. Jeppesen5, M. Kohl-Sobania6, J. B. Mason7, U.-F. Pape8,9, L. Pironi10, L. K. Schwartz11, E. Wright2, P. Zhang2, S. Sabrdaran2

1Department of Gastroenterology, IBD and Nutrition Support, Hôpital Beaujon Clichy, Paris, France, 2Takeda Development Center Americas, Inc., Cambridge, MA, United States, 3Department of Medicine, Toronto General Hospital, University of Toronto, Toronto, ON, Canada, 4Intestinal Care Center and Transplant, MedStar Georgetown Transplant Institute, Washington, DC, United States, 5Department of Transplantation and Digestive Diseases, Rigshospitalet, Copenhagen, Denmark, 6Department of Pediatrics, University Hospital Schleswig Holstein, Lübeck, Germany, 7Divisions of Gastroenterology and Clinical Nutrition , Tufts Medical Center and Tufts University, Boston, MA, United States, 8Department of Internal Medicine and Gastroenterology, Asklepios Klinik St. Georg, Asklepios Medical School, Hamburg, 9Department of Hepatology and Gastroenterology, Charité University Medicine Berlin, Berlin, Germany, 10Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy, 11Department of Internal Medicine, NYU Langone Health, New York, United States

 

Rationale: Teduglutide reduces dependence on parenteral nutrition and/or intravenous fluids in patients with short bowel syndrome and intestinal failure; however, data on exposure during pregnancy are limited. We report pregnancy outcomes from the prospective, global, multicentre SBS Registry (NCT01990040; EUPAS7973).

Methods: Data from patients treated with teduglutide in the SBS Registry who reported pregnancies from June 23, 2014 to March 31, 2025 were analysed cumulatively. Pregnancy outcomes (full/pre-term live births, spontaneous abortions [miscarriages], elective terminations, stillbirths or ectopic pregnancy) and relative timing of teduglutide exposure were summarised descriptively.

Results: Ten female teduglutide-exposed patients with reported pregnancies were included. Mean (standard deviation [SD]) age at conception was 31.2 (6.16) years. Median (range) gestational age at the time of pregnancy outcome was 36.1 (3–40) weeks. Twelve pregnancies were reported, with repeat pregnancies in 2 patients, resulting in 10 full-term live births without congenital anomalies, 3 spontaneous abortions, 1 fetal loss, and 1 unknown pregnancy outcome (Table). Outcomes by teduglutide-exposure pattern varied: spontaneous abortions occurred only among pregnancies with first‑trimester‑only exposure, with advanced maternal age as a possible confounder in 2 cases; full‑term live births without congenital anomalies were reported across all known exposure categories.

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Conclusion: No consistent pattern of adverse pregnancy outcomes associated with teduglutide exposure was observed. Although isolated cases of spontaneous abortion showed temporal associations, the limited case numbers do not support a clear association with teduglutide use. However, alternative explanations including potential confounding factors cannot be excluded.

Disclosure of Interest: F. Joly Consultant for: Commercial relationships as a consultant for Baxter Healthcare, B. Braun, Fresenius Kabi, Nestlé Health Science, Takeda, Therachon and Théradial, Speakers Bureau of: Commercial relationships as a speaker for Baxter Healthcare, B. Braun, Fresenius Kabi, Nestlé Health Science, Takeda, Therachon and Théradial, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; study investigator for NPS Pharmaceuticals, Takeda, VectivBio and Zealand Pharma; having been an advisory board member for Alira Health, ArTara Therapeutics, Baxter Healthcare, Ironwood Pharmaceuticals, M3E Solutions, NorthSea Therapeutics, Takeda, VectivBio and Zealand Pharma, Y. W. Huang Other: Employee of Takeda Development Center Americas, Inc. and has received stock and/or stock options, J. Allard Grant / Research Support from: Research support from OMS as a principal investigator, Consultant for: Fees from Takeda as a consultant, Speakers Bureau of: Fees from Takeda as a speaker, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, G. Gondolesi Grant / Research Support from: Investigator-initiated research grant from Takeda, Speakers Bureau of: Speaker for Takeda, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, P. Jeppesen Consultant for: Commercial relationships as a consultant with Albumedix, ArTara Therapeutics, Baxter Healthcare, Coloplast, Ferring Pharmaceuticals, Fresenius Kabi, GLyPharma Therapeutic, Ironwood Pharmaceuticals, Naia Pharmaceuticals, NorthSea Therapeutics, Novo Nordisk Foundation, Protara Therapeutics, Takeda, Therachon, VectivBio and Zealand Pharma, Speakers Bureau of: Commercial relationships as a speaker with Albumedix, ArTara Therapeutics, Baxter Healthcare, Coloplast, Ferring Pharmaceuticals, Fresenius Kabi, GLyPharma Therapeutic, Ironwood Pharmaceuticals, Naia Pharmaceuticals, NorthSea Therapeutics, Novo Nordisk Foundation, Protara Therapeutics, Takeda, Therachon, VectivBio and Zealand Pharma, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, M. Kohl-Sobania Speakers Bureau of: Fees from Aposan, Takeda and Tauro-Implant as a speaker, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; study investigator for NPS Pharmaceuticals, Inc. and Takeda; advisory board member for Takeda, J. Mason Grant / Research Support from: Research support from Takeda as a site for the study, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; compensation from Care/of, a producer of nutritional supplements; and fees from UpToDate, a web-based medical information platform, for authoring chapters, U.-F. Pape Grant / Research Support from: Research support from Hanmi, Takeda, VectivBio and Zealand Pharma as a study site principal investigator, Consultant for: Fees from Takeda as a consultant, Speakers Bureau of: Fees from Takeda as a speaker, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, L. Pironi Grant / Research Support from: Personal grants for congress presentations from Baxter and B. Braun , Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; advisory board member for Alfasigma, NorthSea Therapeutics and Takeda, L. Schwartz Grant / Research Support from: Research support from Takeda as a study principal investigator, Other: Compensation from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study , E. Wright Other: Employee of Takeda Development Center Americas, Inc. and has received stock and/or stock options, P. Zhang Other: Employee of Takeda Development Center Americas, Inc. and has received stock and/or stock options, S. Sabrdaran Other: Employee of Takeda Development Center Americas, Inc. and has received stock and/or stock options