Research on ulcerative colitis and proctitis

Research on ulcerative colitis and ulcerative proctitis highlights benefits of topical 5-ASA treatments

May 20, 1998

A University of Chicago research team, after a review of all published articles and abstracts, has concluded that topical 5-ASA mesalamine seems to be the most effective medical treatment for achieving remission in patients with active left-sided ulcerative colitis (UC) and ulcerative proctitis (UP). The group, led by Russell Cohen, MD, found that success rates with 5-ASA enemas and suppositories were generally higher than those reported using oral medications and most topical steroid treatments. They will present their findings May 20, 1998 at the Digestive Disease Week conference in New Orleans, Louisiana.

Approximately 250,000 people in the United States suffer from UC and UP. These chronic disorders are characterized by extensive inflammation of the colon (UC) and rectum (UP). Due to differences in disease and medical therapies, patients with UC limited to the left side of the colon are classified as having left-sided UC. Symptoms range from mild to severe and can include persistent bloody diarrhea, abdominal cramps, fever, and weight loss. The increased risk for colon cancer among individuals with long-standing cases of UC can be as high as 32 times the normal rate. This increased risk has not been noted in patients with UP alone.

The causes of UC and UP are unknown, although both genetic and environmental factors are thought to play a role. While there is currently no medical cure, there is a variety of pharmaceutical therapies to treat UC and UP, including pills, capsules, enemas, suppositories, and foams.

Dr. Cohen identified 84 articles and abstracts, published in English, that examined treatment options for left-sided UC and 21 for UP. Each article was reviewed for the success and safety of the medication. Medications were classified by type, dose size, delivery method and duration of treatment. Studies that assessed how well medications worked in patients with active disease were analyzed separately from those that measured how well a drug maintained remission.

"There is a lot of information available, but until now it has been hard to compare the advantages and disadvantages of different treatment options because each study was organized differently," said Dr. Cohen. "Two studies that measured the same medication might each measure different doses, and while one study may last three months, the other could last two years. The purpose of our research was to review and organize the available data to help physicians identify the safest and most effective treatments for left-sided ulcerative colitis and ulcerative proctitis.

Results suggest that medications given as an enema or suppository are more effective than those given as a pill when treating patients with active left- sided UC or UP. In particular, 5-ASA enemas appear to be more effective than 5-ASA orally-administered pills and capsules and, after 6-8 weeks of treatment, than steroid enemas in achieving remission in patients with left- sided UC. The potential for adverse side effects is also much lower for 5-ASA treatments than for steroid treatments. 5-ASA suppositories also outperformed most steroid suppositories or foams in the treatment of UP.

"We found that the rates of patient success in attaining remission, or at least improving, while on 5-ASA treatments were often greater than with steroid treatments," said Dr. Cohen. "We also found that with the 5-ASA treatments the delivery method made a big difference. The topical therapies, enemas and suppositories, were consistently more effective than the orally- administered medications."

This research was funded in part by Solvay Pharmaceuticals, Inc. of Marietta, Georgia, makers of ROWASA 5-ASA enemas and suppositories. Solvay Pharmaceuticals, Inc. is a research-based pharmaceutical company active in the therapeutic areas of women's health, gastroenterology and mental health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

"Dr. Cohen is involved in some very important research, helping doctors find the most effective means of treating these very troubling diseases," said David Dodd, president of Solvay Pharmaceuticals, Inc. "It's vital that we commit the time and resources to find a cure for ulcerative colitis and ulcerative proctitis. Until we do, it's just as important that we be able to help people with these ailments lead the most productive, comfortable lives possible."

Dr. Cohen is an inflammatory bowel disease specialist within the gastroenterology section and an assistant professor of clinical medicine at the University of Chicago's Pritzker School of Medicine. Assisting Dr. Cohen in this research were: Douglas Woseth, a second year medical student at the University; and Stephen Hanauer, MD, co-director of the Inflammatory Bowel Disease Research Center and the outpatient gastroenterology clinic at the University of Chicago Hospitals. Dr. Hanauer is also a professor in the department of Medicine and member of the committee on clinical pharmacology at the University.