Data from the study also showed that Cimzia given every four weeks as monotherapy is significantly more efficacious than placebo in the treatment of patients with active rheumatoid arthritis (RA) who had previously failed disease-modifying anti-rheumatic drug therapy.
In two phase III studies, response levels were significantly higher in both Cimzia treated arms (400mg at week zero, week two and week four followed by 200mg every two weeks plus methotrexate; or 400mg every two weeks plus methotrexate) compared with the placebo plus methotrexate-treated arm, the company said.
UCB also said that effective results in the treatment of RA can be achieved with a 200mg every other week dose of Cimzia – the higher dose is not necessary. The safety and tolerability profile of Cimzia in both studies was consistent with that expected of an anti-TNF agent.
Preparation for a regulatory submission for Cimzia in the treatment of RA is ongoing, with filing planned by the end of 2007.