Chemistry:Certolizumab pegol

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Short description: Pharmaceutical drug
Certolizumab pegol
CertolizumaB 5WUV.png
Syringe with Certolizumab pegol-1800.jpg
Syringe with 200mg Certolizumab pegol
Monoclonal antibody
TypeFab' fragment
SourceHumanized (from mouse)
TargetTNF alpha
Clinical data
Trade namesCimzia
Other namesCDP870
AHFS/Drugs.comMonograph
MedlinePlusa608041
License data
Pregnancy
category
  • AU: C
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Pharmacokinetic data
Elimination half-lifeabout 11 days
ExcretionKidney (PEG only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2115H3252N556O673S16
Molar mass47749.46 g·mol−1
 ☒N☑Y (what is this?)  (verify)

Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease,[1][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]

It is on the World Health Organization's List of Essential Medicines.[6]

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.[4][7][8]
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.[9]
Psoriatic arthritis
On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.[10]

Method of action

Three certolizumab molecules (blue) binding a homotrimer of TNF-alpha (tan). Certolizumab can block TNF in both its soluble form (freely circulating in the bloodstream) and its transmembrane form (bound to the membrane of a cell). From PDB: 5WUX​.[11]

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.[12]

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.[1][12][13][14]
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.[15]
Rheumatoid arthritis
Certolizumab appears beneficial in those with rheumatoid arthritis.[16]

References

  1. ↑ 1.0 1.1 "Certolizumab pegol for the treatment of Crohn's disease". The New England Journal of Medicine 357 (3): 228–238. July 2007. doi:10.1056/NEJMoa067594. PMID 17634458. 
  2. ↑ "Certolizumab pegol". mAbs 2 (2): 137–147. 2010. doi:10.4161/mabs.2.2.11271. PMID 20190560. 
  3. ↑ "CDP-870 (certolizumab) in rheumatoid arthritis". Expert Opinion on Biological Therapy 5 (4): 601–606. April 2005. doi:10.1517/14712598.5.4.601. PMID 15934837. 
  4. ↑ 4.0 4.1 "Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160". December 24, 1999. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000TOC2.cfm. 
  5. ↑ "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". April 24, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4c2c9dc-a0bb-4d64-a667-a67ebe88392d. 
  6. ↑ World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. 2021. WHO/MHP/HPS/EML/2021.02. 
  7. ↑ "Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease". UCB press release. http://www.ucb.com/media-room/newsdetail/?det=1314787. 
  8. ↑ "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. May 1, 2008. http://www.medscape.com/viewarticle/573833. 
  9. ↑ "Cimzia European Public Assessment Report". European Medicines Agency. http://www.emea.europa.eu/humandocs/Humans/EPAR/cimzia/cimzia.htm. 
  10. ↑ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". http://www.ucb.presscentre.com/News/Cimzia-certolizumab-pegol-approved-by-the-U-S-FDA-for-treatment-of-adult-patients-with-active-ps-45c.aspx. 
  11. ↑ "Molecular Basis for the Neutralization of Tumor Necrosis Factor α by Certolizumab Pegol in the Treatment of Inflammatory Autoimmune Diseases". International Journal of Molecular Sciences 18 (1): 228. January 2017. doi:10.3390/ijms18010228. PMID 28124979. 
  12. ↑ 12.0 12.1 "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 54 (suppl 7): A82. 2005. 
  13. ↑ "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 130 (4): A107. 2006. 
  14. ↑ "New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn's Disease" (Press release). UCB. October 23, 2006. Archived from the original on March 29, 2020. Retrieved November 15, 2009.
  15. ↑ "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. May 2013. doi:10.1016/j.jval.2013.03.1150. 
  16. ↑ "Certolizumab pegol (CDP870) for rheumatoid arthritis in adults". The Cochrane Database of Systematic Reviews 2017 (9): CD007649. September 2017. doi:10.1002/14651858.CD007649.pub4. PMID 28884785. 

External links



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