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CIMZIA(R) (certolizumab pegol) Reduces Intestinal Lesions and Induces Endoscopic Improvement in Crohn's Patients
Date:10/6/2008

More than 60 percent of moderate to severe patients achieved endoscopic response and more than 40 percent achieved endoscopic remission at Week 10 in data from a 54-week open-label study presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting

ORLANDO, Fla., Oct. 6 /PRNewswire/ -- UCB today presented data from a large, prospective study investigating endoscopic improvement in Crohn's disease (CD) with a biologic compound. The data presented at the American College of Gastroenterology Annual Scientific Meeting demonstrates that CIMZIA(R) (certolizumab pegol) -- the only PEGylated anti-TNF alpha (Tumor Necrosis Factor alpha) -- significantly improved endoscopic lesions and induced endoscopic response (as assessed by the Crohn's Disease Endoscopic Index of Severity (CDEIS)) within ten weeks of treatment in more than 60 percent of the moderate to severe Crohn's disease patients studied.

"Even though the study was uncontrolled, it is interesting to see evidence of endoscopic improvement so early in the course of treatment," said lead study investigator Jean-Frederic Colombel, M.D., Hepatogastroenterology, CHRU Lille, the Regional Hospital Center of the University of Lille, France. "Long-term follow up of these patients will allow us to determine the clinical impact of endoscopic improvement on modifying the course of the disease."

Data from the 54-week, open-label Phase IIIb MUSIC trial showed significant improvement by Week 10 in CDEIS scores, the primary endpoint of the study. Scores dropped from 14.7 to 8.2 -- a reduction of 6.5 points, or 44 percent improvement compared to baseline. The CDEIS, which ranges from 0 to 44 points, is used to assess the presence of mucosal lesions associated with inflammation along the lining of the gut (ileum, colon and rectum). Mucosal healing has been associated with a lower rate of hospitalization and lower need for surgery.

Improvements in secondary endpoints, including
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SOURCE UCB
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