Cimzia Effective With Stable Dosing In Crohn's Disease

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UCB announced today that data presented at Digestive Disease Week reaffirm the long-term, sustainable efficacy and safety of Cimzia (certolizumab pegol) at stable doses in treating patients with moderate to severe Crohn's disease. Data also showed continued remission amongst the majority of responders and the remission rate remained stable in many of the patients who were re-induced with Cimzia. These results represent data from the PRECiSE trial program, which evaluated more than 1,300 patients receiving continuous treatment with Cimzia (400 mg) for up to 18 months.

"The long-term Cimzia data provide very important information for clinical practitioners treating people with Crohn's disease," said study investigator Gary R. Lichtenstein, M.D., professor of medicine, University of Pennsylvania School of Medicine, Philadelphia, Pa. "In clinical trials, Cimzia showed remarkable and sustainable long-term results without the need for dose escalation. Further, patients can achieve long-term symptom relief and remission regardless of the magnitude and rapidity of onset of the initial response."

Cimzia is the first and only PEGylated anti-TNF (Tumor Necrosis Factor alpha) antibody approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. Cimzia was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2008.

UCB, the manufacturer of Cimzia, presented analyses of the PRECiSE 3 and 4 open-label extension studies, which demonstrated the long-term efficacy of Cimzia in treating Crohn's disease. PRECiSE 3 data showed that eight out of ten patients who were in remission at six months stayed in remission for up to 18 months. Furthermore, 35 percent of patients who had relapsed during PRECiSE 2 but were treated with one additional dose of Cimzia (PRECiSE 4), achieved and maintained remission at six and 12 months with maintenance dosing every 4 weeks and no dose escalation.

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"The DDW meeting marks an exciting time to announce additional long-term data for Cimzia, given its recent approval by the FDA," said Olav Hellebo, Senior Vice President and President of Inflammation Operations, UCB. "UCB remains committed to providing healthcare professionals with effective therapies to improve the lives of patients suffering from this debilitating disease.

In a related analysis of PRECiSE 2 and 3, the durability of long-term maintenance of response and remission proved not to be related to the rapidity or magnitude of response or remission following induction of Cimzia, demonstrating that patients can go on to experience positive response and remission rates regardless of the magnitude and speed of the initial response. [Abstract #T1126]

The pooled data also shows that the PRECiSE Phase 2 and Phase 3 clinical trials showed no unexpected safety findings and no increase in the rate of common adverse events with sustained exposure to Cimzia. Results also demonstrate stable dosing in patients taking the medication for more than six months. [Abstract #469]

About the PRECiSE Clinical Trial Program

PRECiSE, one of the largest, most comprehensive development programs for an anti-TNF for Crohn's disease is composed of two placebo-controlled studies and two open-label safety follow-up studies. In 2007, the two former studies were published in the New England Journal of Medicine (NEJM). The studies demonstrated that patients with moderate to severe Crohn's disease achieved and sustained clinical response with Cimzia for up to six months, compared to placebo. The safety and tolerability of Cimzia was consistent with that expected of an anti-TNF agent. In the first follow-up study, patients completing both initial studies are to be given Cimzia every four weeks for up to seven years. In the second follow-up study, patients who relapsed in either initial study (defined as an increase in CDAI of >70 or absolute CDAI of >350) were re-introduced to Cimzia every four weeks to be continued for up to seven years, with a single additional dose at week 2.

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