Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in Infliximab-Refractory Crohn'... (tient Phase IIIb multicenter 26- W eek t...)

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Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in Infliximab-Refractory Crohn's Patients

Date:6/1/2009

tient Phase IIIb multicenter 26-Week trial Evaluating the clinical benefit and tolerability of certoLizumab pegol induCtiOn and Maintenance in patients suffering from Crohn's disease with prior loss of response or intolErance to infliximab. It consists of an open-label induction phase (400 mg of Cimzia(R) sub-cutaneously at weeks 0, 2 and 4) and a double-blind maintenance period (400 mg of Cimzia(R) every 2 or 4 weeks from Week 6). The primary endpoint was defined as the rate of response (defined as a decrease in CDAI score greater than or equal to 100 points from baseline) at week 6. Remission was defined as a CDAI score of less than or equal to 150 points. After the induction period, 62 percent of patients achieved response and 39 percent achieved remission. One-third of patients had responded to treatment by week 2 (33 percent) and more than forty percent (44 percent) had responded by Week 4.

About Crohn's Disease

Crohn's disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it may result in the need for surgery and hospitalization. Crohn's disease has been estimated to affect as many as half a million Americans. People with Crohn's can experience an ongoing cycle of flare-up and remission throughout their lives. Together with ulcerative colitis, Crohn's disease is an inflammatory bowel disease (IBD).

About CIMZIA(R) (certolizumab pegol)

Cimzia(R) is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia(R) has a high affinity for human TNF-alpha, selectively neutralising the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine play
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