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.
|(N = 210)||9 mg (N = 232)||6 mg (N = 230)|
|Clinical and endoscopic remission, n (%)||13 (6.2)||41 (17.7)||25 (10.9)|
|A vs placebo, %||11.5||4.7|
|95% CI||12.8, 22.6||6.8, 14.9|
|Symptom resolution, n (%)||30 (14.3)||61 (26.3)||50 (21.7)|
|Clinical improvement, n (%)||60 (28.6)||87 (37.5)||65 (28.3)|
|Endoscopic improvement, n (%)||68 (32.4)||97 (41.8)||71 (30.9)|
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.