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

Gastroenterology. 2021 Apr;160(5):1452-1460.e21. doi: 10.1053/j.gastro.2020.10.065. Epub 2021 Jan 6.


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: Crohn’s Disease; Disease Progression; Disease Severity; Ulcerative Colitis.

Publication types

  • Consensus Development Conference
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Clinical Trials as Topic*
  • Colitis, Ulcerative / complications
  • Colitis, Ulcerative / diagnosis
  • Colitis, Ulcerative / mortality
  • Colitis, Ulcerative / therapy*
  • Consensus
  • Cost of Illness
  • Crohn Disease / complications
  • Crohn Disease / diagnosis
  • Crohn Disease / mortality
  • Crohn Disease / therapy*
  • 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