
An interim analysis of a real-world study reporting up to 10 years of follow-up data shows that teduglutide, a human glucagon-like peptide-2 analogue, can provide long-term reductions in parenteral nutrition and/or intravenous fluid (PN/IV) requirements and shorter time to achieve enteral autonomy in adults with short bowel syndrome-associated intestinal failure (SBS-IF).
Global data on efficacy outcomes for all enrolled adults (n=1,404) in the SBS Registry were evaluated between enrolment and interim data cutoff (between June 23, 2014 and June 30, 2024). Study participants were categorized as ever-treated (received at least one dose of teduglutide prior to enrolment; n=692) or never-treated (never received the study drug; n=712). [DDW 2025, abstract Tu1991]
Sixty percent of participants were women, and Crohn’s disease was the most common cause of major intestinal resection (33.9 percent [ever-treated] and 20.4 percent [never-treated]). The mean age at enrolment was 53.5 and 57.3 years in the respective ever- and never-treated arms, mean estimated remaining small intestine length at baseline was 85.4 and 100.87 cm, and median follow-ups were 5.84 and 6.69 years. The mean duration of teduglutide exposure was 47.1 months.
Consistent reductions in PN/IV volume, frequency
“Mean reductions in PN/IV volume and frequency from baseline were seen in the ever-treated arm across all study years,” said the researchers.
In ever-treated patients, the mean baseline PN/IV volume of 10.33 L/week dropped to 8.3 L/week by study year 10. The never-treated cohort saw an increase between the two timepoints (from 12.51 to 12.9 L/week). For study years 1–9, the ever-treated arm had a significantly lower least-squares mean (LSM) PN/IV volume than the never-treated arm (p<0.0001 [years 1–7] and p<0.05 [years 8 and 9]). The LSM differences (LSMDs) across study years 1–9 ranged between -2.02 and -3.07.
The mean PN/IV frequency in the ever-treated arm was 5.29 days/week at baseline and 5.14 days/week at study year 10. Patients in this arm had significantly lower LSM frequency of PN/IV as opposed to those in the never-treated arm (p<0.0001 [years 1–4] and p<0.05 [years 5–7]).
Overall, the comparison between the ever- and never-treated arms yielded LSMDs of -2.31 (-2.45 vs -0.14; p<0.0001) and -0.53 (-0.64 vs -0.11; p<0.0001) for PN/IV volume and frequency, respectively.
The proportion of ever-treated patients who achieved enteral autonomy by data cutoff was twofold higher than that of never-treated patients (26.5 percent vs 13.9 percent), and the former achieved this endpoint significantly faster than the latter (p<0.0001).
“The SBS registry has a large sample size, broad inclusion criteria, long-term follow-up, and international recruitment, which provided comprehensive insights into the long-term effectiveness of teduglutide for SBS-IF,” the researchers said.
However, there may have been referral, selection, and monitoring bias, they pointed out. Teduglutide recipients might have been chosen based on bowel length, severity of their disease, or likelihood of achieving enteral autonomy which, according to the investigators, may have affected the efficacy outcomes.
Nonetheless, ever-treated patients had significant reductions in PN/IV requirements from baseline as opposed to never-treated patients, with more in the former than the latter group achieving enteral autonomy within a shorter period, they said.
“These real-world data support the long-term effectiveness of teduglutide for adult patients with SBS-IF,” the investigators concluded. The ongoing study shall continue to provide longer-term data to further validate the current results.