New treatment option for patients who have moderately active ulcerative colitis

Nov 1 2004

Results of a study presented today by a Mayo Clinic physician at the 69th Annual Scientific Meeting of the American College of Gastroenterology (ACG) in Orlando, Fla., offer a new treatment option for patients who have moderately active ulcerative colitis.

William Sandborn, M.D., of the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minn., says if the treatment receives approval from the Food and Drug Administration, it will provide a new treatment for patients who need higher doses of the drug mesalamine, instead of resorting to steroid therapies, which sometimes have harsh side effects.

“As we have seen in practice for years, there are patients with moderate ulcerative colitis who need higher doses of mesalamine to successfully control their disease,” says Dr. Sandborn. He says it was suspected that a higher dose would be more effective for patients, but the results of the study confirmed their ideas. “This was really the last phase of data needed to move forward with a higher and more convenient dose for the patient,” says Dr. Sandborn.”

The study, sponsored by Procter & Gamble Pharmaceuticals, was a multicenter, randomized, double-blind clinical trial of 268 patients with moderately active ulcerative colitis. Patients were randomly assigned to receive 4.8 grams daily (g/day) of mesalamine (800 mg tablet) or 2.4 g/day mesalamine (400 mg Asacol tablet) for six weeks. Treatment success was evaluated based on clinical and endoscopic assessments.

Results showed 71.8 percent of patients taking 4.8 g/day of mesalamine achieved success, compared to 59.2 percent of patients taking 2.4 g/day of mesalamine.

“Many of our patients with moderately active ulcerative colitis currently take 12 or more mesalamine tablets a day to manage their symptoms,” says Stephen Hanauer, M.D., lead investigator, and Professor of Medicine and Clinical Pharmacology and Chief, Section of Gastroenterology and Nutrition, University of Chicago Pritzker School of Medicine. “The 800 mg tablet in this study enabled patients to receive 4.8g/day of mesalamine in only six tablets.”

Overall adverse events in the study were similar in both treatment groups with the most common side effects (headache, gastrointestinal symptoms, and respiratory symptoms consistent with respiratory infections or flu syndrome) appearing similar to the most commonly reported adverse events seen in other Asacol studies.

The Asacol 400 mg delayed-release mesalamine tablet used in the 2.4 g/day arm of the study was approved in 1992 at a dose of 2.4 g/day for the treatment of mildly to moderately active ulcerative colitis.

Ulcerative colitis involves inflammation of the lining of the colon and rectum and it is characterized by flares followed by periods of remission throughout a lifetime.

Ulcerative colitis varies in clinical severity with patients having mild, moderate or severe disease. The severity of disease is used to determine the appropriate approach to therapy in these patients.

A flare is when the rectum and/or colon become inflamed. During a flare, people experience increased symptoms of ulcerative colitis, such as bloody diarrhea, rectal bleeding, abdominal pain or cramping, and an urgent need to go to the bathroom. Flares can vary in duration and intensity.

While ulcerative colitis is a lifelong condition, flares can be controlled with medication when taken as prescribed by a doctor.

This condition affects people of all ages, but often is diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection, or the immune system.