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CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients
Date:10/7/2008

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WELCOME Study (Abstract #P283)

Data from the Phase IIIb WELCOME study showed that 39 percent of patients who responded to CIMZIA treatment after failing infliximab therapy achieved clinical remission at Week 6 as measured by the Crohn's Disease Activity Index (CDAI). In addition, the study found that 61 percent of study patients reduced CDAI symptom scores by 100 points and 68 percent reduced CDAI scores by 70 points. 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.

Response to CIMZIA was similar when used as a monotherapy or with concomitant corticosteroids or immunosuppressants. There were also no differences in clinical responses to CIMZIA among those patients who had previously lost response to infliximab (62 percent), were hypersensitive to infliximab (61 percent) or both (58 percent).

PRECiSE 3 Study (Abstract #P280)

The PRECiSE 3 (P3) open-label extension study of PRECiSE 1 and PRECiSE 2 was designed to evaluate the longer-term safety and effectiveness of CIMZIA in patients completing the other two studies. The 30-month analysis includes data from 141 patients who have been continuously treated with CIMZIA for 2.5 years. At the beginning of P3, 73 percent of CIMZIA-treated patients were in remission. After 2.5 years (30 months) of treatment with CIMZIA, 72 percent of patients were in remission based upon responder analysis. The incidence of injection site pain was low in the CIMZIA group, and no new safety signals observed over 2.5 years of active treatment.

Pharmacoeconomics Study (Abstract #P277)

A cost analysis for induction and maintenance dosing regimens for CIMZIA, infliximab and adalimumab was estimated for a 65kg patient over a two-year period. Response and remission rates were assumed the same between treatments, and maintenance therapy was followed if r
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