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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

ts as non-, moderate, or good responders, depending on the extent of change and the level of disease activity reached.

The RAPID3 patient-derived assessment of disease activity has been shown to correlate with disease activity score, DAS28, in patients treated with certolizumab pegol. DAS28 is defined as a clinical index of RA disease activity that combines information from swollen joints, tender joints, an acute phase response, and general health.

Previous post-hoc analyses with certolizumab pegol have demonstrated that a lack of improvement in DAS28 (greater than or equal to 1.2) by Week 12 predicts failure to achieve low disease activity at one year. The analysis presented here examined whether RAPID3 or EULAR responses at Week 12 predicted structural joint damage at one year (defined as change from baseline in modified Total Sharp Score [mTSS]) in patients treated with certolizumab pegol plus MTX or placebo plus MTX. The mTSS assesses bone erosion and joint space narrowing measured by X-ray. A smaller change in mTSS reflects less progression of joint damage.

In this post-hoc analysis, patients taking certolizumab pegol 200mg two weekly plus MTX or MTX alone in the RAPID 1 study were evaluated. RAPID 1 was a Phase III double-blind placebo-controlled trial designed to establish the efficacy and tolerability of certolizumab pegol plus MTX in the treatment of moderate to severely active RA in patients who did not adequately respond to treatment. RAPID 1 met the co-primary endpoints which were ACR20 score at Week 24 and change in mTSS at Week 52. At Week 12, patients were categorized according to good, moderate or poor based on RAPID3 or EULAR response criteria. Data were pooled for patients in each group achieving a good or moderate RAPID3 or EULAR response, and progression of joint damage was evaluated in good/moderate versus poor RAPID3 or EULAR responders.

The analysis showed that the rate of mTSS non-progressors at Week 52 was high
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