Key takeaways:
- Sufferers handled with teduglutide had important reductions in parenteral diet/IV fluid wants over 10 years vs. untreated sufferers.
- Handled sufferers additionally had shorter time to realize enteral autonomy.
SAN DIEGO — Sufferers handled with teduglutide had important reductions in parenteral diet and/or IV fluid necessities over 10 years, in addition to shorter period to realize enteral autonomy, in contrast with untreated sufferers.
Teduglutide (Gattex, Takeda) is a glucagon-like peptide-2 analog indicated for sufferers with brief bowel syndrome-associated intestinal failure who depend upon parenteral diet and/or IV fluids, in response to a poster introduced at Digestive Illness Week.
Information derived from Huang YW et al. Lengthy-term effectiveness of teduglutide in adults with brief bowel syndrome-associated intestinal failure: Interim evaluation of the US subpopulation from a worldwide multicenter registry examine. Introduced at: Digestive Illness Week; Could 3-6, 2025; San Diego.
“These real-world information recommend the effectiveness of long-term teduglutide remedy in decreasing parenteral diet and/or IV fluids quantity and frequency for as much as 10 years,” Even Yi Wen Huang, MD, PhD, international medical science lead and medical director of marketed merchandise improvement at Takeda, instructed Healio. “Moreover, a higher variety of sufferers within the ever-treated cohort achieved enteral autonomy extra rapidly in comparison with those that had by no means acquired teduglutide remedy.”
Strategies
Huang and colleagues carried out an interim evaluation of SBS Registry, a worldwide, multicenter potential examine investigating long-term security and efficacy of teduglutide in sufferers with brief bowel syndrome-associated intestinal failure.
The researchers evaluated information from 551 grownup sufferers (imply age, 54.9 years; 62.6% ladies) enrolled at U.S. examine websites from June 23, 2014, to June 30, 2024. Of these, 310 sufferers have been categorised as ever-treated — those that acquired a minimal of 1 dose of teduglutide — and 241 as never-treated — these not handled with teduglutide however who had acquired parenteral diet/IV fluids for at the least 6 months previous to enrollment.
Crohn’s illness was probably the most prevalent reason for main intestinal resection in almost a 3rd of sufferers (30.7%).
Change from baseline in parenteral diet/IV fluid quantity and frequency and proportion of sufferers who achieved enteral autonomy served as efficacy endpoints.
Outcomes
Median follow-up reached 5.87 months for the ever-treated group and 6.94 months for the never-treated group. Imply period of teduglutide publicity was 47.7 months (commonplace deviation, 36.55) within the ever-treated group.
Throughout all 10 years, ever-treated sufferers had imply reductions from baseline in parenteral diet/IV fluid necessities — from a imply quantity of 10.8 L per week (commonplace deviation, 6.72) at baseline to 7.2 L per week (commonplace deviation, 7.96) at yr 10.
Ever-treated sufferers additionally had considerably decrease least-squares imply parenteral diet/IV fluid quantity vs. never-treated sufferers from years 1 by means of 6 (P < .0001 for years 1 and a couple of; P < .05 for years 3-6) and general (P < .0001).
Imply parenteral diet/IV fluid frequency additionally dropped amongst ever-treated sufferers — from 5.8 days per week (commonplace deviation, 1.76) at baseline to five.2 days per week (commonplace deviation, 2.43) at yr 10.
At examine years 1 by means of 4, ever-treated sufferers had considerably decrease least-squares imply parenteral diet/IV fluid frequency vs. never-treated sufferers (P < .05).
As well as, 29.6% of ever-treated sufferers and 18.2% of never-treated sufferers attained enteral autonomy, an consequence achieved considerably quicker amongst ever-treated sufferers (P < .05).
The researchers acknowledged limitations, together with affected person choice bias and variations in baseline traits between teams.
Huang stated that though SBS Registry enrollment is full, sufferers proceed to bear follow-up to supply extra long-term information.
“Medical trials have demonstrated each the efficacy of teduglutide in decreasing 20% or extra of weekly parenteral diet/IV fluid quantity, together with a longtime security profile, in individuals 1 yr of age and older with SBS who’re depending on parenteral help,” Huang stated. “Insights from real-world, long-term information can additional inform illness administration.”
For extra info:
Even Yi Wen Huang, MD, PhD, will be reached at gastroenterology@healio.com.
Sources/Disclosures
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Huang YW et al. Lengthy-term effectiveness of teduglutide in adults with brief bowel syndrome-associated intestinal failure: Interim evaluation of the US subpopulation from a worldwide multicenter registry examine. Introduced at: Digestive Illness Week; Could 3-6, 2025; San Diego.
Disclosures:
Takeda funded the examine. Huang experiences being an worker and receiving inventory at Takeda. Please see the examine for all different authors’ related monetary disclosures.
