A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis

The activity indices, classification, treatment indications, and clinical trial efficacy end points for the medical therapy of patients with Ulcerative Colitis (UC), are discussed. UC is a common gastrointestinal disorder in adults, and the advances in pathophysiology, immunology, and pharmaceutical science have resulted in a large number of medications including biologic agents with potential application to the treatment of UC. The instruments for measuring disease activity are based on clinical and endoscopic disease activity indices. Disease specific quality-of-life instruments for patients with UC include the Rating Form of IBD Patient Concerns and the Inflammatory Bowel Disease Questionnaire (IBDQ). Colonoscopy can be used to classify patients with UC according to the macroscopic extent of disease. All these instruments allow for stratification of patients with clinical remission, mildly active disease, moderately active disease, and severely active disease.