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Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease
Date:5/20/2008

ients who had relapsed during PRECiSE 2 but were treated with one additional dose of Cimzia(R) (PRECiSE 4), achieved and maintained remission at six and 12 months with maintenance dosing every 4 weeks and no dose escalation. [Abstract #T1133]

"The DDW meeting marks an exciting time to announce additional long-term data for Cimzia(R), 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(R), 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(R). 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(R) for up to six months, compared to placebo. The safety and tolerability of Cimzia(R) was consistent with that expected of an anti-TNF agent. In the first follow-
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SOURCE UCB
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