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Endoscopic Improvement Seen in Phase 3B MUSIC Trial for Certolizumab
"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 endoscopic remission and response rates, histological CD score, clinical remission rate and decrease in C-reactive protein level, also were achieved in this study. Specifically, the Crohn's Disease Activity Index (CDAI), showed nearly half (46 percent) of the patients achieved clinical remission at Week 10.
More than 40% of study participants achieved endoscopic remission (CDEIS score "These data underscore the importance of CIMZIA as a comprehensive treatment option for people fighting Crohn's disease," said Dr. Colombel.
CIMZIA is approved for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. CIMZIA, manufactured by UCB, was approved by the U.S. Food and Drug Administration on April 22, 2008. The approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease.
The most common adverse events seen in this study were headache, arthralgia, nausea and anal fissure. The incidence of serious adverse events (SAEs) was nine percent and there were no unexpected safety concerns identified during this study.
The MUSIC trial (endoscopic MUcoSal Improvement in patients with active Crohn's disease treated with certolizumab pegol) is an 89-patient Phase IIIb open-label 54-week trial designed to evaluate the efficacy of certolizumab pegol on resolving the intestinal mucosal lesions in patients with active Crohn's disease. CIMZIA was administered subcutaneously at Weeks 0, 2, 4 and then every four weeks. Adverse events (AEs) were assessed at each visit. The change in CDEIS score from baseline to Week 10 was -6.5 points (from 14.7 to 8.2 on the 44-point scale), which was highly significant (95% confidence interval: -7.6 to -5.3; P