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UCB's Cimzia(R) (certolizumab pegol), Shows Rapid and Sustained Clinical Response in Adult Patients Living with Moderate to Severe Rheumatoid Arthritis
Date:10/17/2009

or equal to 0.001).

(+) Post hoc analysis of RAPID 1

The post hoc analysis of the RAPID 1 study aimed to determine if a more rapid response to certolizumab pegol, together with MTX, was associated with better long-term improvements in physical function, and relief of pain and fatigue, in the treatment of active RA in patients who did not respond to conventional treatment. Patients who responded to treatment with certolizumab pegol 200 mg every two weeks by Week 12 were divided into two subgroups: The earlier Week 6 responders and later Week 12 responders based on responder definitions: ACR20 response or DAS28 change of greater than or equal to 1.2 from baseline. The early Week 6 DAS and ACR20 responders had a higher probability of achieving ACR20/50/70 scores at Week 52 (p < 0.001). By ACR20 definition, 83.1% of the early Week 6 responders maintained an ACR20 response at Week 52 compared to 66.7% of the later Week 12 responders (p < 0.001).

(++) Open label extension study to RAPID 1(028)

The Phase III, open-label extension (OLE) study to RAPID 1 is investigating the long-term efficacy and safety of subcutaneous certolizumab pegol (400 mg every 2 weeks) together with methotrexate in the treatment of signs and symptoms and in the prevention of joint damage in patients with active RA. Patients completing RAPID 1 through 52 weeks (completers), or who were ACR20 nonresponders at Week 12 (confirmed at Week 14) and were to be withdrawn from the study at Week 16 (withdrawers), could continue in the 028 study. The open-label extension study continued to evaluate the effects of certolizumab pegol( )over two years. This analysis was performed in completers (n= 508) with 100 weeks of exposure from RAPID 1 baseline. 95.8% of completers entered open-label treatment, and of these, 91.1% continued in the study after 100 Weeks. ACR response rates in these patients
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