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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.

*Cochran–Mantel–Haenszel test vs placebo; **significant at α = 0.025 (multiple testing); significant at α = 0.05 (exploratory).
 (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, % 11.54.7
 95% CI 12.8, 22.66.8, 14.9
 P value* 0.0002**0.0692
Symptom resolution, n (%)30 (14.3)61 (26.3)50 (21.7)
 P value* 0.0015**0.0294
Clinical improvement, n (%)60 (28.6)87 (37.5)65 (28.3)
 P value* 0.05720.9277
Endoscopic improvement, n (%)68 (32.4)97 (41.8)71 (30.9)
 P value* 0.04100.7849

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.