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New RAPID 1 Post-Hoc Analysis Showed Early Response to Cimzia® (certolizumab pegol) at Week 12 was Predictive of Week 52 Response
Date:11/7/2011

er in patients with good/moderate RAPID3 (79.7%, n=246) or EULAR (78.5%, n=284) responses compared to those with poor RAPID3 (70.1%, n=117) or EULAR (68.4%, n=79) responses in the certolizumab pegol plus MTX group, according to Week 12 responses (last observation carried forward (LOCF)). At Week 52, good/moderate RAPID3 or EULAR responses were higher for those treated with certolizumab pegol plus MTX versus the RAPID3 (63.6%, n=44) or EULAR (69.2%, n=52) responses for those treated with placebo plus MTX, according to Week 12 responses (LOCF).

The analysis showed greater inhibition of radiographic progression in patients treated with certolizumab pegol plus MTX versus those treated with placebo plus MTX, regardless of the level of response (good, moderate, or poor) at Week 12 and how the response was determined (RAPID3 or DAS28). The analysis suggested that for patients receiving MTX, assessing RAPID3 response at Week 12 may be beneficial in aiding clinicians in treatment decisions.

Furthermore, the analysis revealed that at Week 12, the majority of certolizumab pegol plus MTX patients had good/moderate RAPID3 or EULAR responses (66.8% and 77.6% respectively, versus 23.5% and 29.1% for placebo plus MTX). At baseline, mean and median mTSS were similar between Week 12 response groups, and at one year, patients with a poor RAPID3 or EULAR response at Week 12 had a greater increase in mTSS from baseline than those patients with a good/moderate response. Differences between categories were greatest in the MTX alone group.

RAPID 1 showed certolizumab pegol had a low incidence of injection site pain (n=<3 new cases /100 years) and discontinuations due to adverse events (AEs). The most commonly occurring AEs were headache, nasopharyngitis, and upper respiratory tract infections. Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the
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