Induction of Clinical and Endoscopic Remission of Mild to Moderately Active Ulcerative Colitis With Budesonide MMX® 9 mg: Analysis of Pooled Data from Two Phase 3 Studies

Abstract

Purpose: To evaluate the efficacy and safety of budesonide MMX® (B-MMX) 6 mg and 9 mg oral tablets in patients (pts) with active mild to moderate ulcerative colitis (UC), when administered for 8 weeks, compared to placebo (PBO). Methods: Pooled data from two Phase 3 studies evaluating patients achieving clinical and endoscopic remission with B-MMX 9 mg or 6 mg tablets once daily compared with PBO over an 8 week period were analyzed. The primary endpoint was induction of clinical and endoscopic remission; defined by strict criteria with a UCDAI score ≤1 after 8 weeks with scores of 0 for rectal bleeding and stool frequency, no mucosal friability after full colonoscopy, and a ≥1-point reduction from baseline in the endoscopic index score. Clinical improvement (≥3 point reduction in UCDAI), endoscopic improvement (≥1 point reduction in the UCDAI mucosal appearance subscore), and symptom resolution (score of 0 for rectal bleeding and stool frequency from UCDAI) were also evaluated at week 8. Results: 672 patients from the pooled modified intent-to-treat (mITT) population, which included randomized patients who received ≥1 dose of study drug, were treated with PBO, B-MMX 9 mg, or B-MMX 6 mg. The mITT population excluded patients without histological evidence of active disease at baseline or with major eligibility or GCP violations according to ICH E9 Guidelines. Clinical and endoscopic remission for B-MMX 9 mg vs. PBO was 17.7% vs. 6.2% (p=0.0002). Symptom resolution was 26.3% vs. 14.3%, respectively (p=0.0018). Clinical improvement and endoscopic improvement were both numerically greater for B-MMX 9 mg than PBO but not statistically different (Table). Treatment related adverse events, including potential glucocorticoid effects, occurred with similar frequencies across study groups.Table: No Caption available.Conclusion: Pooled data showed that B-MMX 9 mg given once daily is safe and effective for inducing clinical and endoscopic remission and symptom resolution in patients with mild to moderately active UC. Disclosure: Dr. Sandborn- Consultant: Cosmo Pharmaceuticals, Santarus Dr. Travis- Consultant: Cosmo Pharmaceuticals, Santarus Dr. Moro- Employee: Cosmo Pharmaceuticals, Dr. Bala- Investigator: Santarus Dr. Danese- Investigator: Cosmo Pharmaceuticals, Dr. Ballard- Employee: Santarus Dr. Bagin-Employee: Santarus Ms. Gautille- Employee: Santarus Dr. Huang- Employee: Santarus. This research was supported by an industry grant from Cosmo Pharmaceuticals and Santarus.