Randomised clinical trial: delayed-release oral @entity2983 4.8 g/day vs. 2.4 g/day in endoscopic XXXX --ASCEND I and II combined analysis.

@entity1 @entity33 @entity31 @entity134 @entity2983
BACKGROUND: Recent studies have focused on the importance of @entity33 in @entity31 ( @entity31 ). However, it was still unclear whether higher doses of delayed-release @entity2983 ( @entity2983 ) could provide additional benefit. AIM: To examine how two doses of delayed-release @entity2983 (4.8 g/day and 2.4 g/day) from ASCEND I and II compare in their relative ability to heal colonic mucosa over time. METHODS: Primary data from two prospective 6-week, double-blind, randomised studies in @entity1 with mildly to moderately active @entity31 were pooled and analysed retrospectively. The @entity33 analysis focuses on moderately active @entity31 @entity1 (n=391), comprising a majority of @entity1 (84%). Additional analyses examined the relationship between @entity33 and dose, clinical response to therapy and @entity1 quality of life (Inflammatory Bowel Disease Questionnaire, IBDQ). RESULTS: At week 3, @entity33 (endoscopy subscore of 0 or 1) was achieved in 65% of moderately active @entity31 @entity1 on 4.8 g/day and 58% of @entity1 on 2.4 g/day (P=0.219). At week 6, this increased to 80% for 4.8 g/day and 68% for 2.4 g/day (P=0.012). Healing rates with the higher dose were also greater across all extents of disease and in @entity1 with prior @entity134 use. At 6 weeks, clinical response to therapy and @entity33 were found to be well correlated (kappa=0.694). Likewise, the change in IBDQ at week 6 showed a significant relationship with @entity33 (P<0.0001). CONCLUSION: Mucosal healing rates in @entity31 achieved at 6 weeks were statistically significantly higher with delayed-release @entity2983 at 4.8 g/day vs. 2.4 g/day.
