The phase III study, involving nearly 1,000 patients, achieved its co-primary endpoint – the inhibition of progression of structural damage. The trial also showed that in both active treatment arms Cimzia improved the signs and symptoms of RA to a clinically statistically significantly 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, using a new subcutaneous liquid formulation of the drug. Both studies demonstrated that effective results in the treatment of RA can be achieved with a 400mg total monthly dose of Cimzia..
“These results are significant. They showed, for the first time, that the Fc region present in conventional anti-TNFs is not required for activity in rheumatoid arthritis”, commented Professor Edward Keystone, University of Toronto, Canada. “These data confirm that certolizumab pegol may provide a valuable new treatment option for patients with this condition.”