Certolizumab Pegol Approved for the Treatment of Rheumatoid Arthritis

FDA

FDA

The U.S. Food and Drug Administration has approved the use of certolizumab pegol (which will be marketed under the trade name Cimzia) for the treatment of moderate to severe rheumatoid arthritis (RA).  Certolizumab pegol is a novel TNF inhibitor comprised of an antigen-binding domain of a humanized TNF antibody coupled to polyethylene glycol (PEG) to increase half-life, and thus is Fc-domain-free.  Certolizumab is also approved for the treatment of moderate to severe refractory Crohn’s disease, and has been available for this indication since 2008.  With the approval for RA, the drug is now available for subcutaneous injection in a prefilled syringe and as a lyophilized solution that is reconstituted.  Certolizumab is the fifth TNF inhibitor marketed in the U.S. for the treatment of RA.  As with the other approved TNF inhibitors, the FDA has included a black box warning regarding the potential for reactivation of tuberculosis and invasive fungal infections.

Summaries of clinical trials investigating the efficacy and safety of certolizumab in RA previously reported on this site can be found here.

Jon Giles, MD

About Jon Giles, MD