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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.
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.
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