Certolizumab pegol

Certolizumab pegol
Monoclonal antibody
Type Fab' fragment
Source Humanized (from mouse)
Target TNF alpha
Clinical data
Trade names Cimzia
AHFS/Drugs.com Consumer Drug Information
MedlinePlus a608041
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
administration		 Subcutaneous
ATC code L04AB05 (WHO)
Legal status
Legal status
Pharmacokinetic data
Biological half-life about 11 days
Excretion Renal (PEG only)
Identifiers
CAS Number 428863-50-7 N
ChemSpider none
UNII UMD07X179E N
KEGG D03441 YesY
ChEMBL CHEMBL1201831 N
Chemical and physical data
Formula C2115H3252N556O673S16
Molar mass 47,750 g/mol
 NYesY (what is this?)  (verify)

Certolizumab pegol [1] (CDP870, tradename Cimzia) is a biologic medication for the treatment of Crohn's disease,[2] 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.[3][4][5]

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.[4][6][7]
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.[8]
Psoriatic arthritis
On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.[9]

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.[10]

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.[2][10][11][12]
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.[13]
Rheumatoid arthritis
Certolizumab appears beneficial in those with rheumatoid arthritis.[14]

Side effects

Significant side effects occur in 2% of people who take the medication.[14]

References

  1. ↑ Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". MAbs. 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232Freely accessible. PMID 20190560.
  2. 1 2 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.
  3. ↑ Kaushik VV, Moots RJ (April 2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert opinion on biological therapy. 5 (4): 601–6. doi:10.1517/14712598.5.4.601. PMID 15934837.
  4. 1 2 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.
  5. ↑ "Cimzia Prescribing Information" (PDF). US Food and Drug Administration (FDA). April 2016. Retrieved 2016-08-21.
  6. ↑ UCB press release - Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. Retrieved April 22, 2008.
  7. ↑ Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved 2008-05-01.
  8. ↑ "Cimzia European Public Assessment Report". European Medicines Agency. Retrieved November 15, 2009.
  9. ↑ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Retrieved October 1, 2013.
  10. 1 2 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
  11. ↑ 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
  12. ↑ "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.
  13. ↑ 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.
  14. 1 2 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.
This article is issued from Wikipedia - version of the 11/13/2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.