Controlled trial in UC meets primary endpoint of non- inferiority for reducing ulcerative colitis

Oct 28 2009

Results from the largest prospective controlled ulcerative colitis (UC) trial conducted to date, called the QD dosing investigation for efficacy IN UC maintenance (QDIEM), found that once-daily dosing of Asacol(R) (mesalamine) delayed-release 400 mg tablets at 1.6-2.4 g/day was comparable to twice-daily dosing for the maintenance of remission in patients with UC.

The study, which met its primary endpoint of non-inferiority, found that 90.5 per cent of patients taking Asacol once-daily remained in remission at six months compared to 91.8 per cent of patients taking Asacol twice-daily. These findings were announced at the American College of Gastroenterology (ACG) Annual Scientific Meeting in San Diego, California.

At 12 months, approximately 85 per cent of patients maintained remission irrespective of whether they took Asacol once- or twice-daily. The number of serious adverse events and withdrawals due to adverse events were similar for patients in the once-daily and twice-daily Asacol dosing regimens.

"While Asacol is currently indicated for divided dosing, it is encouraging to see that in this study, when Asacol was taken once-daily, the results were comparable to when it was taken twice-daily," said Dr. Pierre Paré, Director of Clinical Research in Gastroenterology, Centre Hospitalier Affilie Universitaire de Québec. "UC is a chronic condition, so it is extremely important that patients take their medication as prescribed, and work together with their physician to determine how to best manage their symptoms and maintain disease remission."

Two recent Canadian studies, comparing preferred medication attributes among UC patients and physicians found that while speed to symptom relief and few side effects are the most important attributes in choosing a treatment option, 35 per cent of patients and 32 per cent of physicians rate once-daily dosing as a preferred medication attribute.(1),(2)

Additional Study Details

The QDIEM study was a multi-centre, randomized, investigator-blinded, 12-month parallel-group study that included 1,027 patients. The study was designed to assess the non-inferiority of once-daily dosing versus twice-daily dosing of Asacol for maintaining clinical remission in patients with UC. Patients were randomized to either the once-daily or twice-daily dosing regimen at the same total daily dose (ranging from 1.6 to 2.4 g/day) that they had taken to maintain remission prior to entering the study. Clinical remission was defined as a Simple Clinical Colitis Activity Index (SCCAI) score of two or less points. Relapse was defined as an SCCAI score greater than or equal to five points. Relapse rates were assessed over the 12-month period using the Cox proportional hazards model. Patients who had not relapsed were considered to be in remission.