Source: DGNews  |  Posted 2 years ago

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