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Cimzia® (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
Date:5/10/2011

erapy were randomized to receive certolizumab pegol (400mg at weeks 0, 2 and 4 followed by 200mg or 400mg every two weeks*) plus MTX, or placebo together with MTX for 24 weeks. The primary outcome measure was ACR 20 response at week 24.

At week 24, significantly more patients in the certolizumab pegol treatment groups reported improvements greater than or equal to MCID in all six PROs (pain, fatigue, patient's global assessment of disease (PtGA), physical function by HAQ, and HRQOL by SF-36 physical and mental component summary scores). The beneficial effects of certolizumab pegol were similar between the 200mg and 400mg dose levels with no significant difference between treatment groups in any PROs.

Furthermore, at week 24, 63% of certolizumab pegol 200mg treated patients reported clinically meaningful improvements in greater than or equal to 1 PRO compared with 13% in placebo groups, and approximately 23% of all certolizumab pegol treated patients reported clinically meaningful improvements in all six PROs compared with 3% in placebo groups.

The NNT for reported changes greater than or equal to MCID in all six PROs was approximately five patients, and these results showed the highest correlation between pain, PtGA and fatigue. The NNT for reported changes greater than or equal to MCID in up to five PROs was 2-3.

Improvements greater than or equal to MCID in pain were investigated to predict outcomes at week 24. Those patients achieving pain MCID by week 12 were more likely to have better outcomes than those who did not achieve MCID at week 12. Additionally, a comparison of week 6 and 12 responders, showed approximately 27% of patients who reported improvements greater than or equal to MCID in pain at week 6 achieved low disease activity (LDA) at week 24, compared with 16% of week 12 responders.

* In the EU, the approved maintenance dose regimen is 200mg every two weeks. In the US, the approved maintenance dose regimen is 200mg e
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SOURCE UCB
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1. New Cimzia® (certolizumab pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations With Active Rheumatoid Arthritis (RA)
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3. UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohns Disease
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