New Data Suggest CIMZIA(R) (Certolizumab Pegol) Active in Treating Moderate to Severe Crohn's Patients With Fistulizi...(Index (CDAI)) at Week 6 were randomized ...)

Date:12/5/2008

Index (CDAI)) at Week 6 were randomized to CIMZIA(R) 400 mg or placebo every 4 weeks until Week 24 with final assessment at Week 26. Of the patients in the intent-to-treat population who responded to CIMZIA(R) induction, 13.6% (58 of 425) had open fistulas at baseline: 30 of these patients were randomized to placebo and 28 to CIMZIA(R) 400 mg.

Among patients who had fistula closure (the absence of drainage on gentle compression) during the study, a higher proportion of those treated continuously with CIMZIA(R) 400 mg (73.3%) maintained 50% fistula closure at Week 26 versus patients receiving placebo (38.5%). More than two-thirds (66.7%) of the CIMZIA(R)-treated patients maintained 100% closure of fistulas compared to placebo (30.8%) at Week 26.

Of the adult, moderate to severe Crohn's disease patients with open fistula at baseline, a higher percentage of patients in the CIMZIA(R) versus placebo group achieved CDAI response of 100 points from baseline (71.4% versus 33.3%, respectively) and CDAI remission (53.6% versus 20%, respectively). The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Scores of <150 indicate remission, and scores of >450 indicate severe illness along the 600 point scale.

Health-related quality of life measurements was assessed by the 32-question Inflammatory Bowel Disease Questionnaire (IBDQ), which measures social, systemic, emotional and bowel related symptoms on a scale of 32 to 224 points (higher scores denote better well-being). In this study, mean change in IBDQ scores from baseline were greater in CIMZIA(R) (36.7 points) than placebo-treated groups (20.7 points).

There was a higher rate of discontinuation from treatment in the placebo group (50%) compared to the CIMZIA(R) group (14%). In the PRECiSE 2 trial, the most common AEs in the CIMZIA(R) group were headache (7%), nasopharyngitis (6%) and cough (6%)
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