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New Cimzia® (certolizumab pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations With Active Rheumatoid Arthritis (RA)
Date:11/9/2010

ATLANTA, Nov. 9, 2010 /PRNewswire/ -- The addition of Cimzia® (certolizumab pegol; CZP) to current therapy was associated with a rapid clinical response, improved function and reduced disease activity in a diverse group of adult rheumatoid arthritis (RA) patients reflecting those seen in daily clinical practice (including those with prior TNF-inhibitor use).  These positive clinical trial data were presented during the American College of Rheumatology's (ACR) 2010 Annual Scientific Meeting in Atlanta, November 7-11. Cimzia®  is approved for the treatment of adults with moderately to severely active rheumatoid arthritis.

"There are patients who live with little relief from the painful symptoms of rheumatoid arthritis due to failed therapies or the severity of the condition," said Roy Fleischmann, MD, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical School.  "These data emphasize that treatment with Cimzia® can substantially provide rapid improvements and help reduce disease activity regardless of the patient's disease history in many of these patients."

The data presented were from the REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) multicenter phase IIIb study, which included a 12-week, randomized, double-blind (DB), placebo-controlled phase followed by an open-label extension (OLE) (greater than or equal to 16 weeks).  REALISTIC was designed to investigate the safety and efficacy of CZP in a broad patient population with active RA more closely resembling routine clinical practice, versus the pivotal trials, including patients with/without prior TNF-inhibitor exposure, with/without concomitant methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs); and varying lengths of disease duration.

The primary endpoint of an ACR20 score at week 12 was met.  At week 12, more than half (51.1%) of patients in the
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1. Rapid and Long-term Clinical Responses Observed in Rheumatoid Arthritis Patients Taking Cimzia® (certolizumab pegol), According to Data Being Highlighted During ACR Meeting
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