Honolulu, Hawaii, October 31, 2005 - A single 400 mg injection of Cimzia (certolizumab pegol, CDP 870) every four weeks was effective in maintaining control of the signs and symptoms of Crohn's disease following induction therapy, according to pivotal phase III research presented this week at the annual meeting of the American College of Gastroenterology.
The study, entitled PRECiSE 2, found that a significantly higher proportion of patients who responded to an induction regimen of 400 mg Cimzia at weeks zero, two and six, were able to maintain clinical response and achieve remission by week 26 when given a single injection every four weeks, compared to those treated with placebo. A regulatory submission for the treatment of Crohn's disease is planned in the US during the first quarter of 2006.
"As there is considerable unmet need in the treatment of Crohn's disease, it is important that the research community continue to explore new therapies," said William J. Sandborn, MD, professor of medicine, Mayo Clinic College of Medicine, Rochester, MN, PRECiSE study investigator. "These data are exciting because it shows that Cimzia holds significant promise in meeting many of these needs."
Crohn's disease is a chronic inflammatory bowel disorder that affects approximately one million people in the US and Europe alone. , Because there is no cure, treatment is focused on suppressing the inflammatory response that is at the root of its cause. Cimzia is a biologic agent that has been designed to inhibit the production of tumor necrosis factor alpha (TNF- ), a protein involved in the inflammation process.
- 64 percent of the 668 patients enrolled in the trial responded to induction therapy by week 6. Those who responded were randomized to receive maintenance treatment with either Cimzia (n=216) or placebo (n=212).
- 62.8 percent of patients receiving Cimzia maintenance therapy sustained an overall cli
Contact: Susan Thiele
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