Real-world inflammatory bowel disease-modification outcomes: A narrative review

Inflammatory bowel diseases (IBDs) culminate in disease progression in many patients. Characterized by chronic inflammation and gastrointestinal damage, IBD negatively impacts quality of life, often requires surgery, and can result in disability. Disease modification has been a target for treatment for other chronic inflammatory diseases, and disease-modification trials will help determine if this approach can prevent disease progression in IBD. The standard protocol items: Recommendations for interventional trials (SPIRIT) consensus has recommended disease-modification endpoints for use in clinical trials, but before such studies are conducted, real-world data can be informative. This review of real-world studies in patients with ulcerative colitis or Crohn’s disease treated with advanced treatments that employed the SPIRIT endpoints identified considerable gaps in the use of recommended disease-modification endpoints. Specifically, no studies used the recommended outcomes for midterm complications of fecal incontinence or bowel damage, or assessed macroscopic proximal disease extension, permanent stoma, or short-bowel symptoms. Long-term complications of cancer or mortality were not assessed over the recommended 5-year period. Additionally, studies have not assessed quality of life using the recommended composite of the 36-Item IBD Questionnaire and 36-Item Short-Form Health Survey. In conclusion, there remains a need to incorporate SPIRIT-recommended disease-modification endpoints in prospective real-world studies in patients with IBD receiving advanced treatments.