Success for Cimzia (certolizumab pegol) with C-EARLY study in RA- UCB Pharma

UCB has announced data that advances potential care options for rheumatoid arthritis (RA) patients who have not been treated with disease-modifying anti-rheumatic drugs (DMARD-na�ve) and who are at risk for highly progressive disease. The Phase III C-EARLY study showed the substantial benefits, at 52 weeks, of adding Cimzia (certolizumab pegol) to optimized methotrexate treatment. The study was designed to evaluate the efficacy and safety of certolizumab pegol (CZP) in combination with optimized methotrexate (MTX) for the treatment of DMARD-na�ve adult patients with early, active RA. Optimized MTX was the highest dose the patient could tolerate up to a maximum of 25mg weekly. For all patients in the study, MTX therapy was initiated with 10mg weekly and increased to 25mg after 6-8 weeks, if well tolerated. At least 15mg weekly of MTX had to be taken to remain in the study.

The study showed that, after 52 weeks, treatment with CZP plus optimized MTX resulted in more patients in sustained remission and low disease activity, greater improvements in the signs and symptoms of rheumatoid arthritis including physical function, and inhibition of structural damage compared with optimized MTX treatment alone. No new safety signals for CZP were reported. Secondary results from the C-EARLY study were also presented at EULAR 2015 and showed that patients treated with CZP plus MTX had greater improvements at one year in pain, disease activity, fatigue and health related quality of life, improved workplace and household productivity, and reduced need for assistance with regular activities compared to patients receiving placebo and MTX.

Based on the results of this study, UCB has submitted a regulatory application to the European Medicines Agency for an extension of the Cimzia indication in RA to include treatment in combination with MTX for adult patients with severe active and progressive RA not previously treated with MTX or other DMARDs.