Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry

Gabriel E. Gondolesi; Ulrich Frank Pape; Joel B. Mason; Johane P. Allard; Loris Pironi; María Núria Virgili Casas; Lauren K. Schwartz; Francisca Joly; André Gabriel; Sasan Sabrdaran; Pinggao Zhang; Martina Kohl-Sobania; Yi Wen Huang; Palle B. Jeppesen

doi:10.3390/nu16152513

Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry

Gabriel E. Gondolesi, Ulrich Frank Pape, Joel B. Mason, Johane P. Allard, Loris Pironi, María Núria Virgili Casas, Lauren K. Schwartz, Francisca Joly, André Gabriel, Sasan Sabrdaran, Pinggao Zhang, Martina Kohl-Sobania, Yi Wen Huang^*, Palle B. Jeppesen

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

1 Citationer (Scopus)

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.

Originalsprog	Engelsk
Artikelnummer	2513
Tidsskrift	Nutrients
Vol/bind	16
Udgave nummer	15
ISSN	2072-6643
DOI	https://doi.org/10.3390/nu16152513
Status	Udgivet - 2024

Bibliografisk note

Funding Information:
S.S., P.Z., and Y.W.H. are employees of Takeda and receive stock and/or stock options. A.G. was an employee of Takeda and received stock and/or stock options at the time of data analysis. G.E.G., U.-F.P., J.M., J.P.A., L.P., M.N.V.C., L.K.S., F.J., M.K.-S., and P.B.J. have received compensation from Takeda as members of the Scientific Advisory Committee for the SBS Registry study. G.E.G. is a speaker for Takeda and has received an investigator-initiated research grant from Takeda. U.-F.P. received consultation and lecture honoraria, grant/research support from Takeda/Shire Pharmaceuticals/NPS and received consultation, lecture, and advisory board honoraria from Zealand Pharma. J.M. has received research support from Takeda as a site for the study, received compensation from Care/of, a producer of nutritional supplements, as a scientific advisory board member, and received honoraria from UpToDate, a web-based medical information platform, for authoring chapters. L.P. is an advisory board member for Baxter, NorthSea Therapeutics and Takeda. L.K.S. is an advisory board member for Takeda and a speaker for Bristol Myers Squibb. F.J. is a study investigator for NPS Pharmaceuticals, Inc., Takeda, VectivBio and Zealand Pharma, is an advisory board member for Alira Health, ArTara Therapeutics, Baxter Healthcare, M3ESolutions, Takeda, Therachon AG, VectivBio and Zealand Pharma, and has commercial relationships as consultant and speaker for Baxter Healthcare, B. Braun, Fresenius, Nestl\u00E9 Health Sciences, Takeda, Therachon AG and Theradial. M.K.-S. is a study investigator for NPS Pharmaceuticals, Inc., Takeda, received honoraria from Aposan, Takeda and Tauro-Implant as a speaker, and is an advisory board member for Takeda. P.B.J. has commercial relationships as consultant and speaker with Albumedix A/S, ArTara Therapeutics, Baxter, Coloplast, Ferring Pharmaceuticals, Fresenius Kabi, GLyPharma Therapeutic, Naia Pharmaceuticals, Northsea Therapeutics, Novo Nordisk Foundation, Protara Therapeutics, Takeda, Therachon AG, VectivBio AG and Zealand Pharma.

Funding Information:
The authors thank Bram Raphael and Elisabeth Genestin for their support in this registry. Medical writing support was provided by Elizabeth Coe PhD of PharmaGenesis Cardiff, Cardiff, UK, and was funded by Takeda Pharmaceuticals USA Inc. in accordance with Good Publication Practice (GPP 2022) guidelines ( www.ismpp.org/gpp-2022 , accessed on 27 March 2024).

Publisher Copyright:
© 2024 by the authors.

Adgang til dokumentet

10.3390/nu16152513

FulltextForlagets udgivne version, 302 KBLicens: CC BY

Citationsformater

Gondolesi, G. E., Pape, U. F., Mason, J. B., Allard, J. P., Pironi, L., Casas, M. N. V., Schwartz, L. K., Joly, F., Gabriel, A., Sabrdaran, S., Zhang, P., Kohl-Sobania, M., Huang, Y. W., & Jeppesen, P. B. (2024). Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry. Nutrients, 16(15), Artikel 2513. https://doi.org/10.3390/nu16152513

Gondolesi, GE, Pape, UF, Mason, JB, Allard, JP, Pironi, L, Casas, MNV, Schwartz, LK, Joly, F, Gabriel, A, Sabrdaran, S, Zhang, P, Kohl-Sobania, M, Huang, YW & Jeppesen, PB 2024, 'Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry', Nutrients, bind 16, nr. 15, 2513. https://doi.org/10.3390/nu16152513

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title = "Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry",

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{\textquoteright}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.",

keywords = "colorectal polyps, Crohn{\textquoteright}s disease, Gattex, GLP-2 analogs, intestinal failure, parenteral nutrition, real-world, Revestive, short bowel syndrome, teduglutide",

author = "Gondolesi, {Gabriel E.} and Pape, {Ulrich Frank} and Mason, {Joel B.} and Allard, {Johane P.} and Loris Pironi and Casas, {Mar{\'i}a N{\'u}ria Virgili} and Schwartz, {Lauren K.} and Francisca Joly and Andr{\'e} Gabriel and Sasan Sabrdaran and Pinggao Zhang and Martina Kohl-Sobania and Huang, {Yi Wen} and Jeppesen, {Palle B.}",

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language = "English",

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T1 - Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry

AU - Gondolesi, Gabriel E.

AU - Pape, Ulrich Frank

AU - Mason, Joel B.

AU - Allard, Johane P.

AU - Pironi, Loris

AU - Casas, María Núria Virgili

AU - Schwartz, Lauren K.

AU - Joly, Francisca

AU - Gabriel, André

AU - Sabrdaran, Sasan

AU - Zhang, Pinggao

AU - Kohl-Sobania, Martina

AU - Huang, Yi Wen

AU - Jeppesen, Palle B.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - colorectal polyps

KW - Crohn’s disease

KW - Gattex

KW - GLP-2 analogs

KW - intestinal failure

KW - parenteral nutrition

KW - real-world

KW - Revestive

KW - short bowel syndrome

KW - teduglutide

U2 - 10.3390/nu16152513

DO - 10.3390/nu16152513

M3 - Journal article

C2 - 39125394

AN - SCOPUS:85200977323

SN - 2072-6643

VL - 16

JO - Nutrients

JF - Nutrients

IS - 15

M1 - 2513

ER -