Post-Marketing Use of Teduglutide in a Large Cohort of Adults with Short Bowel Syndrome-Associated Chronic Intestinal Failure: Evolution and Outcomes

by Selleckchem | Sep 26 2023

Teduglutide, a GLP-2 analogue, has been available in France since 2015 to treat short-bowel-syndrome (SBS)-associated chronic intestinal failure (CIF) but it remains very expensive. No real-life data on the number of potential candidates are available. The aim of this real-life study was to assess teduglutide initiation and outcomes in SBS-CIF patients. All SBS-CIF patients cared for in an expert home parenteral support (PS) center between 2015 and 2020 were retrospectively included. Patients were divided into two subpopulations: prevalent patients, already cared for in the center before 2015, and incident patients, whose follow-up started between 2015 and 2020. A total of 331 SBS-CIF patients were included in the study (156 prevalent and 175 incident patients). Teduglutide was initiated in 56 patients (16.9% of the cohort); in 27.9% of prevalent patients and in 8.0% of incident patients, with a mean annual rate of 4.3% and 2.5%, respectively. Teduglutide allowed a reduction in the PS volume by 60% (IQR: 40-100), with a significantly higher reduction in incident versus prevalent patients (p = 0.02). The two- and five-year treatment retention rates were 82% and 64%. Among untreated patients, 50 (18.2%) were considered ineligible for teduglutide for non-medical reasons. More than 25% of prevalent SBS patients were treated with teduglutide compared to 8% of incident patients. The treatment retention rate was >80% at 2 years, which could be explained by a careful selection of patients. Furthermore, this real-life study confirmed the long-term efficacy of teduglutide and showed a better response to teduglutide in incident patients, suggesting a benefit in early treatment.

Comments:

The study aimed to assess the initiation and outcomes of teduglutide, a GLP-2 analogue, in patients with short-bowel syndrome-associated chronic intestinal failure (SBS-CIF). The study included SBS-CIF patients cared for in an expert home parenteral support (PS) center in France between 2015 and 2020. The patients were divided into two groups: prevalent patients who were already receiving care before 2015, and incident patients whose follow-up started between 2015 and 2020.

A total of 331 SBS-CIF patients were included in the study, with 156 being prevalent patients and 175 incident patients. Among the cohort, teduglutide was initiated in 56 patients, which accounted for 16.9% of the total. The initiation rate was higher in prevalent patients (27.9%) compared to incident patients (8.0%). The mean annual initiation rate was 4.3% for prevalent patients and 2.5% for incident patients.

The use of teduglutide resulted in a significant reduction in the volume of parenteral support (PS) by 60%, with incident patients experiencing a significantly higher reduction compared to prevalent patients (p = 0.02). The two- and five-year treatment retention rates were 82% and 64%, respectively, indicating that a majority of patients continued teduglutide treatment over the long term.

Among the patients who did not receive teduglutide, 50 individuals (18.2%) were deemed ineligible for non-medical reasons. This suggests that teduglutide was not available to a portion of patients who may have otherwise been suitable candidates for the treatment.

The study demonstrated that over 25% of prevalent SBS-CIF patients were treated with teduglutide, while only 8% of incident patients received the treatment. The high treatment retention rate at 2 years (>80%) may be attributed to the careful selection of patients for teduglutide therapy. Additionally, the study suggested that early initiation of teduglutide may lead to a better response in incident patients, highlighting the potential benefits of initiating treatment at an earlier stage.

Overall, this real-life study provided evidence supporting the long-term efficacy of teduglutide in SBS-CIF patients. However, due to the retrospective nature of the study and the limited number of patients initiating teduglutide, further research is necessary to validate these findings and explore the potential benefits of early treatment with teduglutide.