Newly-Approved Cimzia(R) Provides Rapid, Sustained Response in Crohn'... ( Data from WELCOME Study Presente...)

Newly-Approved Cimzia(R) Provides Rapid, Sustained Response in Crohn's Patients

Date:5/20/2008

Data from WELCOME Study Presented at Digestive Disease Week (DDW)

SAN DIEGO, May 20 /PRNewswire/ -- UCB today presented data at the Digestive Disease Week meeting that showed Cimzia(R) (certolizumab pegol) provided an effective and rapid clinical response in more than 60 percent of Crohn's disease patients who were intolerant, or no longer responding to infliximab. Over 39 percent of patients achieved remission by six weeks. Data also showed one-third of patients responded after receiving only the initial dose. [Abstract #494]

"Data from the UCB clinical trials program including the WELCOME and PRECiSE studies has demonstrated that certolizumab pegol is effective in inducing and sustaining clinical response in a broad range of patients with moderate to severe Crohn's disease," said David G. Binion, M.D., director, IBD Center and professor of medicine at the Medical College of Wisconsin in Milwaukee, Wis. "The addition of Cimzia(R) into our pharmacologic armamentarium to control chronic intestinal inflammation is an important advance for patients who suffer from Crohn's disease."

Cimzia(R) is the first and only PEGylated anti-TNFa (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(R), manufactured by UCB, was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2008. The approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease.

The response rates in this study, measured by a decrease (greater than or equal to 100 points from baseline) in the Crohn's Disease Activity Index (CDAI) score, were comparable to those in an earlier study, the PRECiSE 2 trial, where 64 percent of patients in the overall population achieved response to Cimzia(R).

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