Cimzia(R) Study Shows Rapid Reduction Of Symptoms And Inhibition Of Joint Damage Progression In RA

UCB announced today the online publication of pivotal study results showing CIMZIA® (certolizumab pegol), the only PEGylated anti-TNF (Tumor Necrosis Factor) together with methotrexate (MTX) rapidly reduced symptoms of disease and inhibited progression of joint damage in adult patients with active rheumatoid arthritis (RA), with sustained results for up to one year. The RAPID (RA PreventIon of structural Damage) 1 study data is published in Arthritis & Rheumatism, the peer-reviewed journal of the American College of Rheumatology.



Both co-primary endpoints, which included the ACR20 responder rate at Week 24 and the change from baseline in the modified Total Sharp Score (mTSS) at Week 52, were met in the one-year study. Patients in both CIMZIA® together with MTX treatment arms were shown to have a significantly higher ACR20 response at 24 weeks (p

RAPID 1 and a simultaneous study, RAPID 2, are the first large, placebo-controlled Phase III trials demonstrating the efficacy and tolerability of CIMZIA® in the treatment of RA, as part of a clinical trials program involving more than 2,300 patients.



The most commonly reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma). The most commonly reported adverse events were headache, nasopharyngitis, and upper respiratory tract infections. Pooled safety data from both studies showed that the incidence of injection site burning and stinging (n=