Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study.
Enterocutaneous fistula
Teduglutide
Journal
Clinical nutrition ESPEN
ISSN: 2405-4577
Titre abrégé: Clin Nutr ESPEN
Pays: England
ID NLM: 101654592
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
received:
17
01
2022
revised:
23
04
2022
accepted:
30
04
2022
entrez:
25
7
2022
pubmed:
26
7
2022
medline:
27
7
2022
Statut:
ppublish
Résumé
Enterocutaneous fistula (ECF) is a complication of surgery or inflammatory bowel disease associated with disproportionately high healthcare costs, morbidity, and mortality. We performed this proof-of-concept, feasibility, open-label, pilot randomized, crossover study to assess the efficacy and safety of the use of teduglutide (TED) to treat ECF. Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order. The primary efficacy endpoint was decrease in fistula volume by 20% of baseline 3-day average. Secondary efficacy endpoints were: fistula resolution and health-related quality of life questionnaire scores. Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic. Overall subject compliance with daily TED injections was high (98%). Five of six enrolled subjects met the definition for the primary efficacy endpoint; these clinical responses were not observed during the SOC arm in these subjects. One subject experienced complete fistula closure during TED treatment. Adverse events during treatment were uncommon, minor, and usually resolved despite ongoing treatment. Quality of life survey responses were highly variable and did not correlate with fistula changes. Two months of teduglutide treatment was feasible, well-tolerated, and resulted in observable decreases in ECF drainage in the majority of subjects, including spontaneous closure in one subject. This therapy shows promise, but larger, multicenter confirmatory trials are required. GOV: (NCT02889393).
Sections du résumé
BACKGROUND & AIMS
Enterocutaneous fistula (ECF) is a complication of surgery or inflammatory bowel disease associated with disproportionately high healthcare costs, morbidity, and mortality. We performed this proof-of-concept, feasibility, open-label, pilot randomized, crossover study to assess the efficacy and safety of the use of teduglutide (TED) to treat ECF.
METHODS
Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order. The primary efficacy endpoint was decrease in fistula volume by 20% of baseline 3-day average. Secondary efficacy endpoints were: fistula resolution and health-related quality of life questionnaire scores.
RESULTS
Six out of 10 planned subjects were randomized and completed the study, which was terminated early due to slow enrollment during the Covid-19 pandemic. Overall subject compliance with daily TED injections was high (98%). Five of six enrolled subjects met the definition for the primary efficacy endpoint; these clinical responses were not observed during the SOC arm in these subjects. One subject experienced complete fistula closure during TED treatment. Adverse events during treatment were uncommon, minor, and usually resolved despite ongoing treatment. Quality of life survey responses were highly variable and did not correlate with fistula changes.
CONCLUSIONS
Two months of teduglutide treatment was feasible, well-tolerated, and resulted in observable decreases in ECF drainage in the majority of subjects, including spontaneous closure in one subject. This therapy shows promise, but larger, multicenter confirmatory trials are required.
CLINICALTRIALS
GOV: (NCT02889393).
Identifiants
pubmed: 35871951
pii: S2405-4577(22)00255-8
doi: 10.1016/j.clnesp.2022.04.031
pii:
doi:
Substances chimiques
Peptides
0
teduglutide
7M19191IKG
Banques de données
ClinicalTrials.gov
['NCT02889393']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
49-55Informations de copyright
Copyright © 2022 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Yeh – Takeda Pharmaceuticals – consulting fees paid to author for participating as a participant and moderator for virtual advisory board, unrestricted educational grant for fellowship training program; Baxter - consulting fees paid to author for participating as a participant for virtual advisory board; Fresenius Kabi - consulting fees paid to author for participating as a participant for virtual advisory board; TrueLearn - consulting fees paid to author for participating as a participant for virtual advisory board; UpToDate – author royalties for review articles. Vasileiou – none. Abdul Jawad – none. Pust – none. Byers – Takeda Pharmaceuticals – unrestricted educational grant for fellowship training program.