Certolizumab pegol

Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha (TNF-α) and is manufactured by UCB.

It is on the World Health Organization's List of Essential Medicines.

Medical uses

 * Crohn's Disease: On April 22, 2008, the U.S. Food and Drug Administration (FDA) approved Cimzia for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.


 * Rheumatoid arthritis: On June 26, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that the European Commission grant a marketing authorisation for Cimzia for the treatment of rheumatoid arthritis only - the CHMP refused approval for the treatment of Crohn's disease. The marketing authorisation was granted to UCB Pharma SA on October 1, 2009.


 * Psoriatic arthritis: On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.

Method of action
Certolizumab pegol is a monoclonal antibody directed against tumor necrosis factor alpha. More precisely, it is a PEGylated Fab' fragment of a humanized TNF inhibitor monoclonal antibody.

Clinical trials

 * Crohn's disease: Positive results have been demonstrated in two phase III trials (PRECiSE 1 and 2) of certolizumab pegol versus placebo in moderate to severe active Crohn's disease.


 * Axial spondyloarthritis: In 2013, a phase 3 double blind randomized placebo-controlled study found significantly positive results in patient self-reported questionnaires, with rapid improvement of function and pain reduction, in patients with axial spondyloarthritis.


 * Rheumatoid arthritis: Certolizumab appears beneficial in those with rheumatoid arthritis.