Mesalamine Improves Moderately Active Ulcerative Colitis

SAN DIEGO -- In a study presented at the 39th Annual Digestive Disease Week (DDW) meeting in San Diego, 70 percent of patients with moderately active ulcerative colitis (UC) receiving an investigational 800 mg mesalamine tablet dosed at 4.8 g/day under development by Procter & Gamble Pharmaceuticals experienced overall improvement in disease measures. In the study, the investigational tablet and dose were compared to 400 mg mesalamine tablets dosed at 2.4 g/day.

Additionally, patients in the study with a clinical history of more difficult-to-treat disease, such as those who have been previously treated with steroids and/or rectal therapies, received benefit from the investigational 800 mg tablets dosed at 4.8 g/day. Adverse events seen with the investigational 800 mg tablet dosed at 4.8 g/day were comparable to the 400 mg tablet dosed at 2.4 g/day and the discontinuation rate due to adverse events was no different between the two treatments (both 3.9 percent).

"The ASCEND III study is important because it helps us understand which patients may benefit from higher doses of mesalamine," says Stephen Hanauer, professor of medicine and clinical pharmacology chief, the University of Chicago Medical Center. "In this study the investigational 800 mg mesalamine tablet dosed at 4.8 g/day was well-tolerated and helped patients with moderately active UC manage their symptoms."

The ASCEND III study, discussed during an oral presentation at DDW, was designed to further evaluate the clinical benefit of the investigational 800 mg tablet dosed at 4.8 g/day by assessing the non-inferiority of the 4.8 g/day dose versus the 2.4 g/day dose (400 mg mesalamine tablets). The primary endpoint was met -- the investigational 800 mg tablet dosed at 4.8 g/day was efficacious and non-inferior to the 400 mg mesalamine tablet dosed at 2.4 g/day. At Week 6, overall improvement was achieved by 70 percent of patients with moderately active UC on the investigational 800 mg mesalamine tablet (dosed at 4.8 g/day). Overall improvement was determined by clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy.

Additional Study Details
An oral presentation on May 20 announced findings from ASCEND III, a Phase III, 6-week, double-blind, randomized, multi-national, active-control study designed to evaluate the non-inferiority of the investigational 800 mg tablet dosed at 4.8 g/day versus the 400 mg mesalamine tablet dosed at 2.4 g/day in patients with moderately active UC (Physician’s Global Assessment [PGA] = 2). The primary endpoint was overall improvement defined as improvement from baseline at six weeks in the PGA (which was based on the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy) and no worsening in any of the individual clinical assessments. A total of 772 patients were randomized and dosed. The primary objective of non-inferiority was met, and overall improvement was seen in 70 percent (273/389) of patients receiving the 800 mg tablet dosed at 4.8 g/day as compared to 66 percent (251/383) of patients receiving the 400 mg tablet dosed at 2.4g/day. In the study, the investigational 800 mg tablet dosed at 4.8 g/day also demonstrated efficacy in secondary endpoints: clinical remission, rectal bleeding, stool frequency and sigmoidoscopy improvement.

Source: The Procter & Gamble Company