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CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years
Date:10/27/2008

fessor of Medicine at the University of Colorado School of Medicine.

CIMZIA had a low occurrence of treatment discontinuation due to adverse events. The most commonly occurring adverse events were headache, nasopharyngitis, and upper respiratory tract infections. Pooled safety data from the two main phase III trials showed there was a low incidence of injection site burning and stinging (n=<3 new cases /100 patient-years) and a low level of discontinuations due to adverse events (AEs). Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma).

Additional data presented at ACR showed that patients who withdrew from RAPID 1 and 2 trials because they did not achieve an ACR20 response at Week 12 (confirmed at Week 14) nevertheless showed a slowed progression of structural damage within the joints as measured at Week 16 by analysis of radiographic data.

Additional data presented focused on the effect of treatment with CIMZIA together with MTX in quality of life measurements. In RAPID 1, nearly three-quarters of patients achieved improvements in physical function when treated with CIMZIA together with MTX, including 72.4 percent of those initially treated with CIMZIA 200 mg together with MTX or 70.1 percent of those treated with CIMZIA 400 mg together with MTX.

On a 10-point improvement on the Patients Assessment of Arthritis Pain (PAAP) scale, the data showed an average improvement of 39.1 and 38.1 points for those on CIMZIA 200 mg together with MTX and CIMZIA 400 mg together with MTX, respectively.

"It is exciting to see that these patients are deriving and maintaining improvements on multiple levels with continued CIMZIA treatment," noted Philip Mease, M.D., study investigator at the Seattle Rheumatology Associates and Director of Rheumatology Research at Swedish Medical Center. "Reducing pain and discomfort from RA is extremely important, but it is also noteworthy when patients
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