Quality of life for pediatric patients with short bowel syndrome-associated intestinal failure treated with teduglutide
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Published on: November 29, 2024
Danielle Wendel1, Paul W Wales2, Samuel Kocoshis3
1Division of Gastroenterology and Hepatology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington, USA.
Insights
Teduglutide treatment generally maintained health-related quality of life (HRQoL) in pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF) over 96 weeks. Improved HRQoL was linked to baseline stool frequency, treatment duration, remnant small intestine length, and patient age.
Area of Science:
- Pediatric Gastroenterology
- Clinical Research
- Quality of Life Studies
Background:
- Short bowel syndrome-associated intestinal failure (SBS-IF) presents complex care needs impacting pediatric patients and caregivers.
- Health-related quality of life (HRQoL) is a critical outcome measure in managing chronic pediatric conditions like SBS-IF.
Purpose of the Study:
- To assess the impact of teduglutide on the HRQoL of pediatric patients diagnosed with SBS-IF.
- To identify predictors of HRQoL changes during long-term teduglutide treatment in this population.
Main Methods:
- Analysis of data from two long-term extension studies (NCT02949362, NCT02954458) involving pediatric patients with SBS-IF receiving teduglutide.
- HRQoL was evaluated over 96 weeks using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and the PedsQL Family Impact Module.
- Investigated changes in HRQoL over time and the influence of enteral autonomy attainment.
Main Results:
- In pediatric patients with SBS-IF (n=69) receiving teduglutide, mean patient-reported PedsQL scores were 75.0 (SD 16.2) and remained stable over 96 weeks.
- Higher baseline stool frequency predicted improved patient-reported HRQoL.
- Longer teduglutide exposure, increased remnant small intestine length, and older age predicted higher caregiver-proxy-reported HRQoL.
Conclusions:
- Teduglutide treatment demonstrated stable HRQoL in pediatric patients with SBS-IF over a 96-week period.
- Key predictors for improved HRQoL included baseline stool frequency, duration of teduglutide treatment, remnant small intestine length, and patient age.
- Future research should include pre-treatment HRQoL assessments to better interpret findings.
Objectives:
The complex care needs of pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF) can negatively impact the health-related quality of life (HRQoL) of patients and their caregivers. We assessed the impact of teduglutide on HRQoL of pediatric patients with SBS-IF.
Methods:
Two long-term extension (LTE) studies (NCT02949362, NCT02954458) assessed HRQoL over 96 weeks using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and the PedsQL Family Impact Module. Patients included in this analysis received teduglutide in one of three randomized Phase 3 parent studies and the respective LTE study. We assessed changes in HRQoL over time, as well as the impact of attaining enteral autonomy on HRQoL and predictors of change in HRQoL.
Results:
In pediatric patients with SBS-IF receiving teduglutide (n = 69), the total mean (standard deviation) patient-reported PedsQL score was 75.0 (16.2). Higher mean number of stools per day at LTE study baseline (p = 0.03) predicted increased patient-reported HRQoL. Longer teduglutide exposure (p = 0.047), increasing length of remnant small intestine (p = 0.034), and older age (p = 0.026) predicted higher caregiver-proxy-reported HRQoL. Mean PedsQL scores remained stable over 96 weeks regardless of patients achieving enteral autonomy.
Conclusions:
HRQoL of pediatric patients with SBS-IF treated with teduglutide was generally stable over 96 weeks. Predictors of improved HRQoL included higher baseline stool number, longer teduglutide treatment duration, greater length of small intestine, and older age. To better understand these observations, future studies should assess HRQoL before initiation of treatment.
Clinical Trial Registration:
Clinical trials NCT02949362 and NCT02954458.
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