O020 - LONG-TERM EFFECTIVENESS OF TEDUGLUTIDE IN ADULTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE OUTSIDE THE USA: A GLOBAL, PROSPECTIVE, MULTICENTRE REGISTRY

O020

LONG-TERM EFFECTIVENESS OF TEDUGLUTIDE IN ADULTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE OUTSIDE THE USA: A GLOBAL, PROSPECTIVE, MULTICENTRE REGISTRY

F. Joly^1,*, Y. W. Huang², J. P. Allard³, P. B. Jeppesen⁴, J. B. Mason⁵, L. K. Schwartz⁶, G. E. Gondolesi⁷, U.-F. Pape^8,9, S. Ritter¹⁰, S. Milicevic¹¹, L. Pironi¹²

¹Beaujon Hospital, Paris, France, ²Takeda Development Center Americas, Inc., Cambridge, United States, ³Toronto General Hospital, Toronto, Canada, ⁴Rigshospitalet, Copenhagen, Denmark, ⁵Tufts Medical Center and Tufts University, Boston, ⁶NYU Langone Health, New York, ⁷MedStar Georgetown Transplant Institute, Washington, United States, ⁸Asklepios Klinik St. Georg, Asklepios Medical School, Hamburg, ⁹Charité University Medicine Berlin, Berlin, Germany, ¹⁰Cytel Inc. [Contracted to Takeda Development Center Americas, Inc. at the time of the study], Cambridge, United States, ¹¹Takeda Pharmaceuticals International AG, Zurich, Switzerland, ¹²University of Bologna, Bologna, Italy

Rationale: Teduglutide can reduce dependence on parenteral nutrition and/or intravenous fluids (PN/IV) in patients with short bowel syndrome and intestinal failure (SBS-IF); however, weaning protocols vary by country, particularly at non‑US sites with more centralised specialty care for rare conditions. We report interim results on the long-term effectiveness of teduglutide from the non-US adult cohort in the global, prospective, multicentre SBS Registry (NCT01990040; EUPAS7973).

Methods: Data for adults enrolled at non-US sites in the SBS Registry from June 23, 2014 to March 31, 2025 were analysed. Patients either received (ever-treated) or never received teduglutide (never-treated). Effectiveness outcomes included time to achieve enteral autonomy and change from baseline in PN/IV requirements (volume and frequency).

Results: In total, 853 adults in the non-US cohort (61.1% of adults in the registry) were included; most from Europe (94%). Mean (standard deviation [SD]) age at enrolment was 55.7 (15.68) years; 58.6% of patients were women. Median (range) duration of follow-up was 7.1 (2.8–8.9) years. A greater proportion of ever-treated patients (22.3%) achieved enteral autonomy than never-treated patients (10.5%), with earlier achievement in the ever-treated group (p<0.0001; Figure). Overall, ever-treated patients had greater reductions from baseline in PN/IV requirements than never-treated patients (least-squares mean [standard error] volume, –4.06 [0.284] L/week vs –0.71 [0.221] L/week; frequency, –1.56 [0.113] days/week vs –0.45 [0.088] days/week), with significant differences between the groups in years 1–8 and overall (p<0.0001).

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Conclusion: These data support the long-term effectiveness of teduglutide in adults with SBS-IF in reducing PN/IV requirements and enabling achievement of enteral autonomy at non-US sites. Data collection is ongoing.

Disclosure of Interest: F. Joly Consultant for: Advisory board member for Alira Health, ArTara Therapeutics, Baxter Healthcare, Ironwood Pharmaceuticals, M3E Solutions, NorthSea Therapeutics, Takeda, VectivBio, and Zealand Pharma, Speakers Bureau of: Commercial relationships as a consultant and speaker for Auxens, Baxter Healthcare, B. Braun, Fresenius Kabi, Nestlé Health Sciences, Takeda and Théradial, Other: Compensation received 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, 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: Takeda as a study site principal investigator (PI); research support from OMS as a PI, Consultant for: Takeda, Speakers Bureau of: Takeda, Other: Compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, P. Jeppesen Consultant for: Commercial relationships as consultant and 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/Ironwood and Zealand Pharma, Other: Compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, J. Mason Grant / Research Support from: Takeda as a site for the study, Other: Compensation received 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, L. Schwartz Grant / Research Support from: from Takeda as a study site PI, Other: Compensation received 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: Takeda, Other: Compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, U.-F. Pape Grant / Research Support from: Hanmi, Takeda, VectivBio, and Zealand Pharma as a study site PI, Consultant for: Takeda, Speakers Bureau of: Takeda, Other: Compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study, S. Ritter Other: Employee of Cytel Inc. and funded by Takeda Development Center Americas, Inc. to perform statistical analyses for this study, S. Milicevic Other: Employee of Takeda Pharmaceuticals International AG and has received stock and/or stock options, L. Pironi Grant / Research Support from: Personal grants for congress presentations from Baxter and B. Braun, Consultant for: Advisory board member for Alfasigma, NorthSea Therapeutics, and Takeda, Other: Compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study