UCB (ATLANTA, Georgia), a global biopharmaceutical company, announced results of an international, multicenter, placebo-controlled phase III study (RAPID 1) involving nearly 1000 patients that evaluated the investigational agent Cimziaâ„¢ (certolizumab pegol). This agent is the first PEGylated, Fc-free anti-TNF intended for the treatment of moderate-to-severe rheumatoid arthritis (RA). RAPID 1's radiographic data showed that Cimzia in combination with methotrexate prevented structural damage of the joints to a significantly greater degree than placebo plus methotrexate after 1 year of treatment.

RAPID 1, using lyophilized Cimzia, achieved its coprimary endpoint by inhibiting progression of structural damage, and showed a statistically significantly smaller change from baseline in modified Total Sharp Score (mTSS) as observed at week 52 in both Cimzia treatment arms (400 mg at week zero, week 2, and week 4 followed by 200 mg every 2 weeks, or 400 mg every 2 weeks) compared with the placebo treated arm (P <.001). The study also showed that in both active treatment arms Cimzia improved the signs and symptoms of RA to a statistically greater degree than the placebo arm in patients who had inadequately responded to methotrexate alone (P <.001). Similar results were observed with a second pivotal phase III study of Cimzia in RA (RAPID 2) using Cimzia's new subcutaneous liquid formulation and involving 634 patients.

In both RAPID 1 and RAPID 2, the primary endpoint, ACR 20 response at 24 weeks, was significantly higher in both Cimzia treated arms than in the placebo treated arm (P <.001). In both studies there was no significant difference between response levels in either of the Cimzia treatment arms. ACR 50 and ACR 70 responses were also both achieved with statistical significance in both studies.

RAPID 1 and RAPID 2 demonstrated that effective results in the treatment of RA can be achieved with a 400 mg total monthly dose of Cimzia; a higher dose is not necessary.

The data from the RAPID studies demonstrated that Cimzia also had a rapid onset of action: approximately 75% of actively-treated patients who achieved ACR 20 at week 24, actually reached ACR 20 within 4 weeks. Both studies show that maximal response can be achieved as early as 12 to 16 weeks.

Cimzia retains the potency of the original antibody without the possible cytotoxicity mediated by the Fc portion present in conventional anti-TNFs. The safety and tolerability profile of Cimzia in both studies was consistent with that expected of an anti-TNF agent.

A new drug application for the treatment of RA is expected to be submitted to the US FDA during the second half of 2007. UCB filed a biologics license application with the FDA for Cimzia in the treatment of Crohn's disease on February 28, 2006, and, for the same indication, submitted a marketing authorization application to the European Medicines Agency on April 28, 2006.

—A. Techman

E-mail any comments to .