UCB (BRUSSELS, Belgium) reported that data from a large, prospective study investigating endoscopic improvement in Crohn's disease (CD) demonstrated that Cimzia^® (certolizumab pegol), the only PEGylated anti-TNFα biologic, significantly improved endoscopic lesions and induced endoscopic response, as assessed by the Crohn's Disease Endoscopic Index of Severity (CDEIS) within 10 weeks of treatment in >60% of the moderate-to-severe CD patients.

Data from the 54-week, open-label phase IIIb MUSIC (endoscopic MUcoSal Improvement in patients with active CD treated with certolizumab pegol) trial showed significant improvement in CDEIS scores by Week 10, the study’s primary endpoint. Scores dropped from 14.7 to 8.2, a 44% improvement compared with baseline (95% confidence interval: -7.6 to -5.3; P <.0001). Mucosal healing has been associated with a lower rate of hospitalization and lower need for surgery. In addition, more than 60% of the patients responded (defined as a reduction of ≥5 points in CDEIS scores) to Cimzia treatment. Significant improvements also were shown by histological analysis. Patients will be followed to determine the clinical impact of endoscopic improvement on disease course.

The MUSIC trial is an 89-patient trial designed to evaluate the efficacy of certolizumab pegol on resolving the intestinal mucosal lesions in patients with active CD. Cimzia was administered subcutaneously at Weeks 0, 2, 4, and then every 4 weeks.

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. Specifically, the Crohn's Disease Activity Index (CDAI) showed that 46% of the patients achieved clinical remission at Week 10.

The therapy was approved by the US FDA on April 22, 2008 based on safety and efficacy data from clinical trials in >1500 patients for reducing the signs and symptoms of CD and maintaining clinical response in adult patients with moderate-to-severe active disease who have an inadequate response to conventional therapy.