UCB (BRUSSELS, Belgium) announced positive results from the first phase II clinical trial of CIMZIA^TM (certolizumab pegol, CDP870), the first and only PEGylated Fab' fragment of a humanized anti-TNF-α antibody, in the treatment of patients with moderate-to-severe chronic plaque psoriasis. The phase II, randomized, double-blind, placebo-controlled dose-ranging study involved 176 patients who were candidates for systemic therapy and/or photo- or photochemo-therapy. The patients were randomized to placebo or one of two different subcutaneous drug dosing regimens; CIMZIA 400 mg given every other week, or an initial dose of CIMZIA 400 mg followed by a dose of CIMZIA 200 mg given every other week. The proportion of patients achieving a 75% decrease from baseline in Psoriasis Area and Severity Index (PASI 75) score following treatment at week 12 for placebo, 200 mg, and 400 mg CIMZIA was 6.8%, 74.6% (P <.001), and 82.8% (P <.001), respectively. Results also suggest CIMZIA to be well-tolerated, with the level of adverse events as expected for an anti-TNF therapy. A 24-week follow-up period to this study is currently ongoing, and a retreatment study is also in progress.

In April 2006, UCB submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the approval of CIMZIA in the treatment of patients with Crohn's disease. The European submission follows the filing of a Biologics License Application (BLA) for CIMZIA by the US FDA in March 2006. If approved, CIMZIA will become the first and only biologic administered by monthly subcutaneous injection as a treatment for Crohn's disease patients. On-going phase III studies are investigating the efficacy and tolerability of CIMZIA in the treatment of rheumatoid arthritis.