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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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  • Catherine Le Berre
  • Laurent Peyrin-Biroulet
  • SPIRIT-IOIBD study group
  • Pia Susanne Munkholm (Member of study group)
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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.

Original languageEnglish
JournalGastroenterology
Volume160
Issue number5
Pages (from-to)1452-1460.e21
ISSN0016-5085
DOIs
Publication statusPublished - Apr 2021

Bibliographical note

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

    Research areas

  • 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

ID: 68917294