UCB Pharmaceuticals, Inc, the North American subsidiary of UCB (Brussels, Belgium), announced that a single 400 mg injection of Cimziaâ„¢ (certolizumab pegol, CDP 870) every 4 weeks was effective in maintaining control of the signs and symptoms of mild to moderate Crohn's disease following induction therapy (400 mg Cimzia at weeks 0, 2, and 6). Cimzia is a humanized antibody Fab' fragment chemically linked to polyethylene glycol (PEG; ie, PEGylated) that inhibits the production of tumor necrosis factor-alpha.

The 26-week pivotal phase III study, titled PRECiSE, found that 64% of the 668 enrolled patients had responded to the open-label induction therapy by week 6. The responders were then randomly assigned to receive either a once-monthly maintenance dose of Cimzia or placebo.  Nearly 63% of patients receiving Cimzia maintenance therapy sustained an overall clinical response (100 point drop in the Crohn's Disease Activity Index, CDAI) throughout the 26-week study period versus 36% with placebo. Forty-eight percent of patients receiving Cimzia maintenance therapy were in clinical remission (CDAI <150) at week 26, compared to 28.8% with placebo. A regulatory submission for the treatment of Crohn's disease is planned in the US for the first quarter of 2006.

—A. Techman