By Bruce Sylvester
SAN DIEGO -- October 27, 2009 -- Even among patients who have previously used corticosteroids to control ulcerative colitis, treatment with mesalamine granules 1.5 g allows these individuals to remain in remission from the disease for at least 30 months, according to a study presented here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting.
"Ulcerative colitis is a chronic disease that requires continuous management and it is critically important to provide patients with a treatment option that will offer long-term symptom relief," said Gary R. Lichtenstein, MD, Inflammatory Bowel Disease Program, University of Pennsylvania, Pennsylvania, Philadelphia.
"This data further demonstrates that mesalamine granules 1.5 g is a safe and effective option to maintain remission, even for ulcerative colitis patients who have previously received steroid therapy."
During a poster presentation on October 26, Dr. Lichtenstein identified patients previously treated with steroids who participated in 2 identical clinical trials assessing the efficacy of mesalamine granules in ulcerative colitis.
"What is important to realise about this population of patients is that those on steroids are considered the sickest patients, so being able to maintain these patients in remission is important and meaningful," said coauthor Glenn Gordon, MD, Center for Digestive and Liver Diseases, Inc., Mexico, Missouri.
Originally, 102 patients in the studies had previously used steroids and 77% of them had achieved remission from the disease. Another 52 patients who had used steroids were in the placebo arm of the main study of which 55% achieved remission after 6 months (P < .04). In the open-label, 2-year extension trial, 74 individuals participated.
After 24 months about 67% of patients were still free of ulcerative colitis attacks -- a difference which continued to be significantly different that placebo, based on Poisson regression analysis (P = .0001), said coauthor Kunal Merchant, PhD, Clinical Development, Salix Pharmaceuticals, Montville, North Carolina.
The results of this long-term trial demonstrate that the reduced risk of treatment emergent adverse events and ulcerative colitis-related symptoms that were observed in the original 6-month trial were sustained over the next 24 months. Dr. Merchant said the trial has now ended.
She said about 98% of the patients in the open-label extension of the trial were adherent in taking the mesalamine granules therapy once a day. She said there were only 4 patients among those who had been taking steroid who experienced a serious adverse event. There were no deaths in the study.
Funding for this study was provided by Salix Pharmaceuticals.
[Presentation title: Long Term Maintenance With Mesalamine Granules (1.5 g) in Patients Previously Treated With Corticosteroids Is Associated With a Low Incidence of Ulcerative Colitis-Related Adverse Events. Abstract 718]
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