UCB REPORTS POSITIVE DATA ON ARTHRITIS DRUG

UCB has announced key results from a Phase III study (RAPID 1) involving nearly 1,000 patients on Cimzia (certolizumab pegol), the first PEGylated, Fc-free anti-TNF intended for the treatment of moderate to severe rheumatoid arthritis (RA). The trial'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 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 weeks zero, two and four followed by 200 mg every two weeks, or 400mg every two weeks) compared with the placebo arm.

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. Similar results were observed with a second pivotal Phase III study of Cimzia in RA, RAPID 2, using Cimzia's new subcutaneous liquid formulation.

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

The data from the studies also demonstrate that Cimzia has 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. Additionally, the safety and tolerability profile of Cimzia in both studies was consistent with that expected of an anti-TNF agent.