By Bruce Sylvester
SAN DIEGO -- October 29, 2009 -- The likelihood of relapse in patients with ulcerative colitis is associated more with the extent of underlying illness than with how long they had the disease or when the last flare occurred, according to research presented here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting.
"The most influential prognostic factor [in these patients] was the mucosal score at baseline," announced Gary Lichtenstein, MD, Inflammatory Bowel Disease Program, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, speaking here at a poster presentation on October 26.
The mucosal appearance score is part of the Sutherland Disease Activity Index, a validated instrument used to measure the extent of damage caused by ulcerative colitis. Dr. Lichtenstein noted that other independent prognosticators of a relapse -- using data gleaned from 2 studies -- included the Disease Activity Index score (P = .0217) if the score was 1 or greater when compared with a score of 0; stool frequency score (P = .106) for scores higher than 0; physician's assessment of disease (P = .0136) if the score is higher than 0; and the mucosal score (P = .0007) if the score is higher than 0.
In a multivariate analysis, the mucosal score emerged as the most influential predictor of relapse (P = .0003).
"What we really are showing is that the patients who are the sickest at baseline are the ones who are most likely going to relapse," said coauthor Kunal Merchant, PhD, Salix Pharmaceuticals, Montville, North Carolina. "That is not really a surprising outcome."
The main results of the study at 6 months demonstrated that more patients in remission from ulcerative colitis actually stayed in remission over a 24-week period when treated once daily with mesalamine granules 1.5 g when compared with placebo. These pooled results from 2 clinical studies have previously been reported.
Dr. Lichtenstein noted that, in the 2 studies, treatment with mesalamine granules also predicted that patients were more likely to remain in remission, despite their pretreatment scores, when compared with patients who were being treated with placebo.
"Mesalamine granules 1.5 g once daily demonstrated a significant protective effect in the long-term management of remission of ulcerative colitis during the 6-month treatment period after controlling for prognostic factors," he said. This substudy was undertaken to analyse which conditions were most likely to cause failure, which turned out to be mucosal condition. The researchers also found that mesalamine granules were effective despite underlying disease.
Funding for this study was provided by Salix Pharmaceuticals, Inc.
[Presentation title: Effect of Prognostic Factors on Maintenance of Remission From Ulcerative Colitis in Patients Treated With Once-Daily Mesalamine Granules (1.5g). Abstract 717]
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