|Source||Humanized (from mouse)|
|AHFS/Drugs.com||Consumer Drug Information|
|ATC code||L04AB05 (WHO)|
|Biological half-life||about 11 days|
|Excretion||Renal (PEG only)|
|Chemical and physical data|
|Molar mass||47,750 g/mol|
|(what is this?)|
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.
Approvals and indications
- Crohn's Disease
- On 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 arthritis
- On 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 arthritis
- On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.
Method of action
- 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.
- Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". MAbs. 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
- Sandborn WJ, Feagan BG, Stoinov S, et al. (July 2007). "Certolizumab pegol for the treatment of Crohn's disease". N. Engl. J. Med. 357 (3): 228–38. doi:10.1056/NEJMoa067594. PMID 17634458.
- Kaushik VV, Moots RJ (April 2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert opinion on biological therapy. 5 (4): 601–6. doi:10.1517/147125188.8.131.521. PMID 15934837.
- index.cfm?fuseaction=Search.Label_ApprovalHistory "Cimzia Label and Approval History" Check
|url=value (help). Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 2009-11-15.
- "Cimzia Prescribing Information" (PDF). US Food and Drug Administration (FDA). April 2016. Retrieved 2016-08-21.
- UCB press release - Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. Retrieved April 22, 2008.
- Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved 2008-05-01.
- "Cimzia European Public Assessment Report". European Medicines Agency. Retrieved November 15, 2009.
- "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Retrieved October 1, 2013.
- Schreiber S. et al.,Certolizumab pegol, a humanised anti-TNF pegylated FAb' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a phase 3 study (precise),Gut,2005,54,suppl7,A82
- Sandborn et al., Certolizumab pegol administered subcutaneously is effective and well tolerated in patients with active Crohn's disease: results from a 26-week, placebo-controlled Phase 3 study (PRECiSE 1),Gastroenterology, 2006,130,A107
- "New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn's Disease" (Press release). UCB. October 23, 2006. Retrieved 2009-11-15.
- Sieper J, Tubergen A, Coteur G, Woltering F, Landewe R (May 2013). "PMS50 – Rapid Improvements In Patient-Reported Outcomes With Certolizumab Pegol In Patients With Axial Spondyloarthritis, Including Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis: 24-Week Results Of A Phase 3 Double Blind Randomized Placebo-Controlled Study". Value in Health. 16 (3): A227. doi:10.1016/j.jval.2013.03.1150. Retrieved 2013-05-18.
- Ruiz Garcia, V; Jobanputra, P; Burls, A; Cabello, JB; Vela Casasempere, P; Bort-Marti, S; Kynaston-Pearson, FJ (Sep 18, 2014). "Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.". The Cochrane database of systematic reviews. 9: CD007649. doi:10.1002/14651858.CD007649.pub3. PMID 25231904.
- certolizumab pegol at the US National Library of Medicine Medical Subject Headings (MeSH)
- Cimzia Website