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Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD

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Le Berre, Catherine ; Peyrin-Biroulet, Laurent ; SPIRIT-IOIBD study group ; Munkholm, Pia Susanne. / Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease : the SPIRIT Consensus From the IOIBD. In: Gastroenterology. 2021 ; Vol. 160, No. 5. pp. 1452-1460.e21.

Bibtex

@article{0d384d83353c45688057a22f7efde7d4,
title = "Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD",
abstract = "BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), are chronic and disabling disorders. Prospective disease-modification trials to prevent disease progression are eagerly awaited. However, disease progression is not clearly defined. The objective of the Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative was to achieve international expert consensus on the endpoints to be used in future IBD-disease modification trials.METHODS: This initiative under the auspices of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) began with a systematic literature search to evaluate the current evidence on the definition of disease progression in IBD. On October 22, 2019, a consensus meeting took place during the United European Gastroenterology Week (UEGW) Congress in Barcelona, during which predefined proposed statements were discussed in a plenary session and voted on anonymously. Agreement was defined as at least 75% of participants voting for any one statement.RESULTS: The group agreed that the ultimate therapeutic goal in both CD and UC is to prevent disease impact on patient's life (health-related quality of life, disability, fecal incontinence), midterm complications (encompass bowel damage in CD, IBD-related surgery and hospitalizations, disease extension in UC, extraintestinal manifestations, permanent stoma, short bowel syndrome), and long-term complications (gastrointestinal and extraintestinal dysplasia or cancer, mortality).CONCLUSIONS: Recommendations on which goals to achieve in disease-modification trials for preventing disease progression in patients with IBD are proposed by the SPIRIT consensus. However, these recommendations will require validation in actual clinical studies before implementation in disease-modification trials.",
keywords = "Clinical Trials as Topic, Colitis, Ulcerative/complications, Consensus, Cost of Illness, Crohn Disease/complications, Disability Evaluation, Disease Progression, Endpoint Determination, Fecal Incontinence/etiology, Functional Status, Humans, Quality of Life, Research Design, Severity of Illness Index, Time Factors, Treatment Outcome, Crohn's Disease, Ulcerative Colitis, Disease Severity",
author = "{Le Berre}, Catherine and Laurent Peyrin-Biroulet and {SPIRIT-IOIBD study group} and Munkholm, {Pia Susanne}",
note = "Copyright {\textcopyright} 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.",
year = "2021",
month = apr,
doi = "10.1053/j.gastro.2020.10.065",
language = "English",
volume = "160",
pages = "1452--1460.e21",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B./Saunders Co",
number = "5",

}

RIS

TY - JOUR

T1 - Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease

T2 - the SPIRIT Consensus From the IOIBD

AU - Le Berre, Catherine

AU - Peyrin-Biroulet, Laurent

AU - SPIRIT-IOIBD study group

A2 - Munkholm, Pia Susanne

N1 - Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.

PY - 2021/4

Y1 - 2021/4

N2 - BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), are chronic and disabling disorders. Prospective disease-modification trials to prevent disease progression are eagerly awaited. However, disease progression is not clearly defined. The objective of the Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative was to achieve international expert consensus on the endpoints to be used in future IBD-disease modification trials.METHODS: This initiative under the auspices of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) began with a systematic literature search to evaluate the current evidence on the definition of disease progression in IBD. On October 22, 2019, a consensus meeting took place during the United European Gastroenterology Week (UEGW) Congress in Barcelona, during which predefined proposed statements were discussed in a plenary session and voted on anonymously. Agreement was defined as at least 75% of participants voting for any one statement.RESULTS: The group agreed that the ultimate therapeutic goal in both CD and UC is to prevent disease impact on patient's life (health-related quality of life, disability, fecal incontinence), midterm complications (encompass bowel damage in CD, IBD-related surgery and hospitalizations, disease extension in UC, extraintestinal manifestations, permanent stoma, short bowel syndrome), and long-term complications (gastrointestinal and extraintestinal dysplasia or cancer, mortality).CONCLUSIONS: Recommendations on which goals to achieve in disease-modification trials for preventing disease progression in patients with IBD are proposed by the SPIRIT consensus. However, these recommendations will require validation in actual clinical studies before implementation in disease-modification trials.

AB - BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), are chronic and disabling disorders. Prospective disease-modification trials to prevent disease progression are eagerly awaited. However, disease progression is not clearly defined. The objective of the Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative was to achieve international expert consensus on the endpoints to be used in future IBD-disease modification trials.METHODS: This initiative under the auspices of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) began with a systematic literature search to evaluate the current evidence on the definition of disease progression in IBD. On October 22, 2019, a consensus meeting took place during the United European Gastroenterology Week (UEGW) Congress in Barcelona, during which predefined proposed statements were discussed in a plenary session and voted on anonymously. Agreement was defined as at least 75% of participants voting for any one statement.RESULTS: The group agreed that the ultimate therapeutic goal in both CD and UC is to prevent disease impact on patient's life (health-related quality of life, disability, fecal incontinence), midterm complications (encompass bowel damage in CD, IBD-related surgery and hospitalizations, disease extension in UC, extraintestinal manifestations, permanent stoma, short bowel syndrome), and long-term complications (gastrointestinal and extraintestinal dysplasia or cancer, mortality).CONCLUSIONS: Recommendations on which goals to achieve in disease-modification trials for preventing disease progression in patients with IBD are proposed by the SPIRIT consensus. However, these recommendations will require validation in actual clinical studies before implementation in disease-modification trials.

KW - Clinical Trials as Topic

KW - Colitis, Ulcerative/complications

KW - Consensus

KW - Cost of Illness

KW - Crohn Disease/complications

KW - Disability Evaluation

KW - Disease Progression

KW - Endpoint Determination

KW - Fecal Incontinence/etiology

KW - Functional Status

KW - Humans

KW - Quality of Life

KW - Research Design

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

KW - Crohn's Disease

KW - Ulcerative Colitis

KW - Disease Severity

UR - http://www.scopus.com/inward/record.url?scp=85103723576&partnerID=8YFLogxK

U2 - 10.1053/j.gastro.2020.10.065

DO - 10.1053/j.gastro.2020.10.065

M3 - Journal article

C2 - 33421515

VL - 160

SP - 1452-1460.e21

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 5

ER -

ID: 68917294