Certolizumab pegol (CDP870, tradename Cimzia) is a biologic 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.
Crohn's DiseaseOn April 22, 2008, the U.S. FDA approved Cimzia for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.
Rheumatoid arthritisOn June 26, 2009, the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA) 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 arthritisOn September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active
psoriatic arthritis.
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.
Crohn's diseasePositive 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 spondyloarthritisIn 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 arthritisCertolizumab appears beneficial in those with rheumatoid arthritis.
Significant side effects occur in 2% of people who take the medication.
