P162. Induction of clinical and endoscopic remission with budesonide MMX in mild to moderately active ulcerative colitis: Pooled data from two phase 3 studies

S. Travis¹, S. Danese², L. Moro³, E.D. Ballard⁴, R. Bagin⁴, T. Gautille⁴, M. Huang⁴, W. Sandborn⁵

¹John Radcliffe Hospital, Gastroenterology Unit, Oxford, United Kingdom; ²Istituto Clinico Humanitas, Milan, Italy; ³Cosmo Pharmaceuticals, Lainate, Italy; ⁴Santarus, San Diego, CA, United States; ⁵University of California, San Diego, La Jolla, United States

Background: We evaluated clinical and endoscopic remission with budesonide MMX (BudMMX) 6 mg and 9 mg oral tablets vs placebo in patients (pts) with mild to moderately active ulcerative colitis (UC).

Methods: Data were pooled from two completed phase 3 studies that evaluated 8 weeks of once-daily BudMMX 9 mg or 6 mg, or placebo (sponsors: Cosmo Technologies Ltd, Santarus Inc.; NCT00679380 and NCT00679432). The primary endpoint was induction of clinical and endoscopic remission after 8 weeks defined by strict criteria: UC-DAI score </=1 plus rectal bleeding and stool frequency scores of 0, no mucosal friability after full colonoscopy, and >/=1-point reduction from baseline in endoscopic index score. Secondary endpoints included clinical improvement (>/=3-point reduction in UC-DAI), endoscopic improvement (>/=1-point reduction in UC-DAI mucosal appearance subscore), and symptom resolution (rectal bleeding and stool frequency UC-DAI score 0).

Results: Across the two studies 672 pts were randomised, received >/=1 dose of study drug or placebo and had histological evidence of active disease at baseline without major eligibility or GCP violations according to ICH E9 Guidelines (forming the modified intent-to-treat population). Clinical and endoscopic remission for BudMMX 9 mg was significantly greater than placebo: 17.7% vs 6.2%, respectively (p = 0.0002). Symptom resolution was 26.3% vs 14.3%, respectively (p = 0.0015), clinical improvement and endoscopic improvement were both numerically, but not significantly, greater for BudMMX 9 mg than placebo (Table). Treatment-related adverse events occurred with similar frequencies with BudMMX 9 mg, 6 mg and placebo, including potential glucocorticoid effects.

Conclusions: These pooled phase 3 data show that once-daily BudMMX 9 mg was well tolerated and induced significantly greater rates of clinical and endoscopic remission (strict criteria) and symptom resolution than placebo in pts with mild to moderately active UC.