Cimzia® Is The First Anti-TNF Shown To Inhibit Progression Of Joint Damage As Early As 16 Weeks In Rheumatoid Arthritis

UCB has announced new data showing that Cimzia® (certolizumab pegol), the only PEGylated, Fc-Free anti-TNF (Tumor Necrosis Factor), combined with methotrexate (MTX), significantly inhibits progression of joint damage in patients with active rheumatoid arthritis (RA) as early as 16 weeks after the start of treatment. Presented at the European League Against Rheumatism (EULAR) meeting in Paris, these data are the first to show such rapid inhibition of progression of structural damage in patients receiving an anti-TNF.



These findings are from a post-hoc analysis of the RAPID 1 and 2 trials, two large, international, multi-centre placebo-controlled RA studies, of 52 and 24 weeks' duration, respectively. Previously-presented results from these studies have shown that Cimzia®, in combination with MTX, significantly inhibited progression of structural damage at Week 24 (RAPID 1: Cimzia® 200 and 400mg p

On April 22, 2008, the US Food and Drug Administration (FDA) approved Cimzia® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy. The U.S. FDA also agreed to accept, for filing and review, a Biologics License Application (BLA) for Cimzia® for the treatment of adult patients with active rheumatoid arthritis (RA) in February, 2008. Preparation for submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Cimzia® in the treatment of RA is ongoing, with filing planned by mid 2008.




About RAPID


The RAPID series of clinical trials were designed to establish the efficacy and tolerability of Cimzia® (certolizumab pegol) in the treatment of rheumatoid arthritis. The RAPID clinical trial program is comprised of two large, international, multi-centre placebo-controlled studies - RAPID 1 (027) and RAPID 2 (050).



In the year-long RAPID 1 trial, 982 patients were randomly allocated to receive one of three treatment regimens: Cimzia® 400 mg at the start of the study and at Weeks 2 and 4, then 200 mg given every 2 weeks, together with MTX; Cimzia® 400 mg every 2 weeks, together with MTX; or placebo every 2 weeks, together with methotrexate. In all three arms of the study, the dose of methotrexate was 10-30 mg per week.



Co-primary endpoints for RAPID 1 were the ACR20 response rateb at Week 24 and the change from baseline in the mTSS at Week 52.



Six month ACR response rates for RAPID 1


 Placebo & MTXCimzia® (certolizumab pegol) 200mg & MTXCimzia® (certolizumab pegol) 400mg & MTX
Six months   
ACR 2013.658.8*60.8*
ACR 507.637.1*39.9*
ACR 703.021.4*20.6*



Six and 12 month mean mTSS changes from baseline for RAPID 1


 Placebo & MTXCimzia® (certolizumab pegol) 200mg & MTXCimzia® (certolizumab pegol) 400mg & MTX
Six months1.30.2*0.2*
12 months2.80.4*0.2*

* p