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New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and Significant Symptom Improvement in Moderate to Severe Crohn's Patients
Date:10/26/2009

SAN DIEGO, Oct. 26 /PRNewswire/ -- New data from an open-label extension study evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol) in moderate to severe Crohn's disease patients demonstrate that 82 percent of patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha (Tumor Necrosis Factor alpha) - remained in long-term remission without dose escalation up to 3.5 years. In a separate analysis, CIMZIA significantly improved patients' symptoms as early as day 8 as reported in a post-hoc responder analysis of PRECiSE 2, the original double-blind placebo controlled study. These data from PRECiSE 2 and the open-label extension PRECiSE 3 studies are being presented this week at the American College of Gastroenterology (ACG) Annual Meeting in San Diego, Calif.

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

"These data further demonstrate that treatment with a stable dose of CIMZIA enables patients with Crohn's disease to have sustained symptom relief," said study investigator Gary R. Lichtenstein, M.D., Director, Inflammatory Bowel Disease Program, University of Pennsylvania in Philadelphia. "Long-term relief and control of symptoms are vital to helping Crohn's patients manage their disease."

At the start of the open-label extension study, PRECiSE 3, 75 percent of CIMZIA-treated patients (105 out of 141 patients who continued in PRECiSE 3) were in clinical remission. Eighty-two percent of patients who continued in the long-term extension trial on active treatment maintained remission for up to 3.5 years based upon responder analysis. Disease activity was measured by the Harvey-Bradshaw Index (HBI), which tallies the incidence of five clinical items, including general well-being, abdominal pain and number of liq
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