Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry.
Journal
Nutrients
Journal Volume
16
Journal Issue
15
Pages
2513
ISSN
2072-6643
Date Issued
2024-08-01
Author(s)
Gondolesi, Gabriel E
Pape, Ulrich-Frank
Mason, Joel B
Allard, Johane P
Pironi, Loris
Casas, María Núria Virgili
Schwartz, Lauren K
Joly, Francisca
Gabriel, André
Sabrdaran, Sasan
Zhang, Pinggao
Kohl-Sobania, Martina
Jeppesen, Palle B
Abstract
The Short Bowel Syndrome (SBS) Registry (NCT01990040) is a multinational real-world study evaluating the long-term safety of teduglutide in patients with SBS and intestinal failure (SBS-IF) in routine clinical practice. This paper describes the study methodology and baseline characteristics of adult patients who have (ever-treated) or have never (never-treated) received teduglutide. A total of 1411 adult patients (679 ever-treated; 732 never-treated) were enrolled at 124 sites across 17 countries. The mean (standard deviation [SD]) age at enrollment was 55.4 (15.46) years, and 60.2% of patients were women. Crohn's disease was the most common cause of major intestinal resection in both ever-treated (34.1%) and never-treated patients (20.4%). A similar proportion of ever-treated and never-treated patients had a prior history of colorectal polyps (2.7% vs. 3.6%), whereas proportionally fewer ever-treated patients reported a history of colorectal cancer (1.8% vs. 6.2%) or any malignancy (17.7% vs. 30.0%) than never-treated patients. Never-treated patients received a numerically greater mean (SD) volume of parenteral nutrition and/or intravenous fluids than ever-treated patients (12.4 [8.02] vs. 10.1 [6.64] L/week). Ever-treated patients received a mean teduglutide dosage of 0.05 mg/kg/day. This is the first report of patient baseline characteristics from the SBS Registry, and the largest cohort of patients with SBS-IF to date. Overall, ever-treated and never-treated patients had similar baseline characteristics. Differences between treatment groups may reflect variations in patient selection and degree of monitoring.
Subjects
Crohn’s disease
GLP-2 analogs
Gattex
Revestive
colorectal polyps
intestinal failure
parenteral nutrition
real-world
short bowel syndrome
teduglutide
Type
journal article