Su1189 There Is a Different Tissue Transglutaminase (tTG) Distribution in Celiac Disease (CD) and Inflammatory Bowel Disease (IBD) Duodenal Mucosa

Abstract

central review of endoscopic images on patient selection and trial outcomes. Methods: We utilized data from a placebo-controlled randomized trial of Asacol®, an 800mg formulation of mesalamine, conducted in patients with mildly-to-moderately active UC (NCT01059344). Eligible patients had a UC-DAI total score of 4 10 and an endoscopy sub-score 2. Patients were randomized 1:1 to Asacol® 4.8 g/day or placebo for 10 weeks. Outcomes were assessed at weeks 6 and 10. Post-hoc exploratory analyses compared week 6 clinical and endoscopic outcomes in site investigator (SI)and central reader (CR)-defined endoscopically eligible populations, as well as outcomes in CReligible patients using SI versus CR scoring. Results: A total of 281 patients comprised the SI population. Of these, 194 (69%) were considered eligible by the CR and were included in CR-based analyses. The effect size (percent difference Asacol® minus placebo) was consistently greater for all outcomes in the CR-versus SI-defined population (see Table 1). Placebo rates were uniformly greater in the SI population due to inclusion of patients with low endoscopic disease activity as judged by the CR. No difference in effect size was observed between CRand SI-based outcomes at week 6 in the CR-defined population.