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New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and Significant Symptom Improvement in Moderate to Severe Crohn's Patients
Date:10/26/2009

uid stools per day, during the previous 24 hours before the assessment. Each item is scored from 0 to 3 and total scores of less than or equal to 4 signify remission. Most reported adverse events were of mild to moderate intensity. The most serious adverse events (some leading to death) reported were exacerbation of Crohn's disease, serious infections (3 of which were tuberculosis) and malignancies. (Abstract #P716)

In the original PRECiSE 2 trial, moderate to severe Crohn's patients who responded to CIMZIA after an open-label induction phase were randomized to receive CIMZIA or placebo and evaluated for maintenance of clinical response by week 26, of which a significant majority (62 percent) of CIMZIA treated patients maintained their overall clinical response compared to placebo (34 percent, p<0.001). In the separate post-hoc analysis of the PRECiSE 2 trial, three patient-reported Crohn's Disease Activity Index (CDAI) components (number of loose/liquid stools, abdominal pain, and general well-being) were examined from baseline (day 0) to day 8 to 14, comparing week 6 responders and nonresponders to CIMZIA treatment. The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Patients completed a diary card daily for 7 days prior to each clinic visit. Scores of <150 indicate remission and scores of >450 indicate severe illness along the 600 point scale. There was a 31 percent (95% CI: -1.7, -1.2) reduction of mean number of loose/liquid stools among responders versus a 14 percent (95% CI: -1.0, -0.3) reduction for nonresponders by day 8. Twenty percent of CIMZIA responders reported no abdominal pain by day 8 versus 16 percent of nonresponders (p= 0.002). Approximately 21 percent of CIMZIA responders reported improvement in general well-being scores versus 14 percent of nonresponders (p=0.001). (Abstract #P286)

"These data further underscore the value of CIMZIA as a therapeutic o
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