P185 Comparison of bowel sonography and entero-MRI for diagnosis of small bowel Crohn's disease

Abstract

(normal stool frequency and cessation of bleeding; pts’ diaries). Normal stool frequency (UC-DAI stool frequency subscore 0), clinical remission (abbreviated UC-DAI score 0), treatment failure (need for disallowed treatments), and non-bleeding stools (UC-DAI rectal bleeding subscore 0) at week 4 were also analysed. Observed case analyses are shown. Categorical variables were analysed by Cochran-Mantel Haenszel chisquared test and time-to-endpoint variables by Cox survival analysis, all adjusted by country. Results: 206 pts were enrolled and 202 included in intent-totreat analyses (n = 101 per arm). OD 5-ASA was superior to BD for mucosal healing at week 8 (87.5% vs 71.1% respectively; difference 16.4% [CIs 4.5 28.2]; P= 0.007). Median time to remission was significantly shorter with OD vs BD dosing (26 vs 28 days, respectively; P= 0.042). Time to cessation of bleeding was not significantly different (13 vs 21 days, respectively; P= 0.139). At week 4, significantly more pts had normal stool frequency with OD vs BD dosing (P= 0.013); there was no significant difference in rates of clinical remission, treatment failure or non-bleeding stools. Conclusions: 4 g OD 5-ASA was non-inferior to BD dosing. Moreover, significantly more pts with active UC achieved mucosal healing at week 8 and normal stool frequency at week 4 with 4 g 5-ASA OD vs BD, and median time to remission was significantly shorter with OD therapy. Other secondary endpoints were similar with OD and BD dosing at week 4. These data are consistent with those seen for maintenance of remission, and suggest that OD Pentasa® offers potential benefits to pts.