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Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the
Catherine Le Berre1, Laurent Peyrin-Biroulet2,
1Institut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France.
Insights
The Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative established consensus on key goals for inflammatory bowel disease (IBD) trials. These goals aim to prevent disease progression and improve patient quality of life in Crohn's disease (CD) and ulcerative colitis (UC).
Area of Science:
- Gastroenterology and Clinical Trials
- Inflammatory Bowel Disease (IBD) Research
- Clinical Outcome Assessment
Background:
- Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions requiring effective disease-modification trials.
- A clear definition of disease progression is crucial for designing successful IBD trials.
- The Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative aimed to address this gap by seeking expert consensus.
Framework:
- The SPIRIT initiative involved a systematic literature review and an international consensus meeting.
- Predefined statements on IBD disease progression endpoints were discussed and anonymously voted on.
- Consensus was defined as at least 75% agreement among participants.
Implementation:
- The consensus identified key therapeutic goals for IBD management.
- These goals encompass preventing immediate impacts on quality of life, midterm complications, and long-term adverse outcomes.
- Specific outcomes include improved quality of life, reduced disability, fewer hospitalizations, and prevention of cancer and mortality.
Implications:
- The SPIRIT consensus provides crucial recommendations for future IBD disease-modification trials.
- These recommendations focus on defining and measuring disease progression to guide therapeutic strategies.
- Further validation in clinical studies is necessary before widespread implementation of these endpoints.
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.
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