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Mild to Moderate Ulcerative Colitis Responds to Once-Daily Mesalamine Formulation: Presented at ACG

By Paula Moyer

HONOLULU, HI -- November 8, 2005 -- Patients with mild to moderate ulcerative colitis have higher rates of remission and improvement when treated with an investigative once-daily formulation of mesalamine, SPD476 (Mesavance), investigators reported here at the 70^th annual meeting of the American College of Gastroenterology (ACG).

"Once-daily treatment with SPD476 achieves … remission and is well tolerated," said presenting investigator William J. Sandborn, MD, Professor of Medicine in Gastroenterology, Mayo College of Medicine, Rochester, Minnesota, United States, in his presentation on November 1^st. "These findings are very important to advancing the treatment of ulcerative colitis."

The investigative formulation uses lipophilic and hydrophilic coatings to delay and extend drug delivery, and to confine more of the drug to the colon. It can be taken on a once-daily basis.

Dr. Sandborn and colleagues conducted a phase 3 study that evaluated the efficacy and tolerability of SPD476 once daily against a delayed-release formulation of mesalamine (Asacol) three times daily, and placebo.

The 8-week double-blinded study involved 343 patients with mild to moderate disease. Asacol was administered at a dose of 0.8 g three times daily, while Mesavance was administered at 2.4 g once daily or 4.8 g once daily.

The study design defined remission as a disease activity index score of no more than 1 for rectal bleeding and 0 for stool frequency score.

After week 8, remission was achieved in 40.5% of patients on the 2.4 g daily dose of Mesavance, 41.2% of those on 4.8 g daily of Mesavance, 32.6% of Asacol subjects, and 22.1% of placebo subjects. These results were significantly superior for the two Mesavance doses (P </= .033) but not for Asacol.

Clinical remission, defined as complete resolution of symptoms, was observed in 41.7 of those on Mesavance at the 2.4 g dose and 41.2% of those on the 4.8 g dose, and 33.7% of those on Asacol, compared to 22.1% of those on placebo. The results were significantly superior for the investigative arms (P </= .033) but not for the comparator arm.

All three treatment arms had a higher rate of clinical improvement than placebo, with a rate of 60.7%, 64.7%, and 55.8%, respectively, compared to 39.5% for the placebo group (P </= .033). Similarly, the treatment groups had significantly higher rates of sigmoidoscopic improvement (70.2%, 76.5%, 60.5%, and 41.9%; P </= .033).

Treatment failures occurred more frequently in the placebo group (47.7%), compared to the treatment groups (21.4%, 20.0%, 27.9%; P </= .033).

Four patients, two in the placebo group, withdrew from the study due to adverse events related to their ulcerative colitis, but not to the treatment.

The study was funded by Shire Pharmaceuticals, which manufactures Mesavance. Dr. Sandborn is a consultant for Shire, but has no financial investment.


[Presentation title: Comparison of the Efficacy and Safety of SPD476, a Novel, Once-Daily, High-Dose Formulation of Mesalamine, and Asacol with Placebo for the Induction of Remission of Mild-Moderate Ulcerative Colitis: a Phase III Study. Abstract 22]

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