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New Data From REALISTIC Study Showed Cimzia® (certolizumab pegol) Provided Rapid and Sustained Efficacy, Over 28 Weeks, in a Broad Population of Patients With Moderate to Severe Rheumatoid Arthritis (RA) Including Those Who Discontinued Prior Anti-T
Date:11/7/2011

placebo to certolizumab pegol after 12 weeks.*  

A total of 770 patients who had previously been given certolizumab pegol, and 184 patients who had been given placebo, entered the extension study. At 28 weeks, ACR20 response rates were 59.7% (n=770) for patients taking certolizumab pegol for 28 weeks and 53.3% (n=184) for those taking it for 16 weeks following the initial placebo phase. DAS28(CRP) remission (DAS28 <2.6) was achieved in 22.9% and 21.7% (p=no significant difference) of patients, respectively, while DAS28(ESR) remission (DAS28 <2.6) was achieved in 15.2% and 11.4% (p=no significant difference) of completers, respectively.

Treatment with certolizumab pegol was associated with rapid and consistent efficacy and sustained improvements in disease activity and physical function up to Week 28 in a diverse group of patients with RA closely resembling those seen in routine clinical practice. Rapid efficacy was also seen across patients receiving concomitant DMARDs at baseline, regardless of the number or type of concomitant DMARDs.

In the placebo controlled portion of the trial, the most common serious infections were lower respiratory tract and lung infections. The most common adverse events were infections and infestations, musculoskeletal and connective tissue disorders, and nervous system disorders. Incidence of adverse in the OLE phase was 305.8 events per 100 patient years in patients randomized to certolizumab pegol in the double blind period compared to 406.2 in patients randomised to placebo and switched to certolizumab pegol in the OLE. Incidence of serious adverse events per 100 patient years was 14.7 vs 16.3, respectively.

* Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

For further Information:
Scott Fleming, Global Communications Manager – Immunology
T +44 770.277.737
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SOURCE UCB
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