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GEN News Highlights : Feb 23, 2007

UCB’s RA Drug Shows Positive Phase III Results

Data demonstrates reduction in joint damage.

UCB reported a Phase III study of its treatment for moderate-to-severe rheumatoid arthritis (RA)  prevented structural damage of the joints.

The trial, RAPID 1, was undertaken in 1,000 patients on Cimzia™ (certolizumab pegol), a PEGylated, Fc-free anti-TNF. In combination with methotrexate, the company states, Cimzia prevented joint damage to a significantly greater degree than placebo plus methotrexate after one year of treatment.

RAPID 1 achieved its co-primary endpoint, the inhibition of progression of structural damage, with a statistically significantly smaller change from baseline in modified Total Sharp Score observed at week 52 in both Cimzia treatment arms (400 mg at week zero, week two, and week four followed by 200 mg every two weeks; or 400 mg every two weeks) compared with the placebo treated arm (p<0.001).

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<0.001).

Similar results were observed with a second pivotal Phase III study, RAPID 2, using Cimzia’s new subcutaneous liquid formulation. 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 demonstrate that Cimzia also had a rapid onset of action; approximately three-quarters of actively treated patients who achieved ACR 20 at week 24, actually reached ACR 20 within four weeks.