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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

BRUSSELS and CHICAGO, Nov. 7, 2011 /PRNewswire/ -- UCB today announced new data which showed that treatment with Cimzia® (certolizumab pegol) was associated with a rapid and sustained clinical response over 28 weeks in a broad population of moderate to severe rheumatoid arthritis (RA) patients. The results, presented during the American College of Rheumatology's (ACR) 2011 Annual Scientific Meeting in Chicago, November 5-9, are from an open-label extension of the REALISTIC (RA EvALuation In Subjects receiving TNF Inhibitor Certolizumab pegol) study, and demonstrated consistent efficacy and improved physical function irrespective of prior anti-TNF therapy, concomitant disease modifying antirheumatic drugs (DMARDs), or duration of disease.

"These results are encouraging because they show that the rapid improvement in disease activity, as a result of the clinical response to certolizumab pegol, is sustained in patients who failed on previous therapies," said co-lead investigator Maxime Dougados, MD, Professor of Rheumatology, Rene Descartes University, Department of Rheumatology B, Cochin Hospital, Paris. "The data from the REALISTIC study is of interest because the trial included a broad RA patient population, which reflects aspects of the diversity we see day-to-day in clinical practice."*

Patients (n=1,063) who had participated in the 12-week randomized, double-blind, placebo-controlled REALISTIC study, either on certolizumab pegol or placebo plus DMARD, were given the option of participating in an open-label extension (OLE) study for a further 16 weeks (28 weeks in total). In total 954 patients entered the extension study and were given certolizumab pegol, including those patients that were previously treated with placebo in the 12-week controlled period of the trial. At Week 28, positive efficacy results were comparable between patients who had received certolizumab pegol for 28 weeks in total and those that switched from
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