Certolizumab pegol

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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
 ☒NcheckY (what is this?)  (verify)

Certolizumab pegol, sold under the brand name Cimzia, is a biologic 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[edit]

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[edit]

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[edit]

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]

Side effects[edit]

Significant side effects occur in 2% of people who take the medication.[16]

References[edit]

  1. ^ a b 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.
  2. ^ Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". mAbs. 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
  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. S2CID 21974683.
  4. ^ a b "Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 18 July 2020.
  5. ^ "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". DailyMed. 24 April 2020. Retrieved 18 July 2020.
  6. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  7. ^ UCB press release - Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease Archived 2012-02-18 at the Wayback Machine. Retrieved April 22, 2008.
  8. ^ Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved 2008-05-01.
  9. ^ "Cimzia European Public Assessment Report". European Medicines Agency. Archived from the original on November 9, 2009. Retrieved November 15, 2009.
  10. ^ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Archived from the original on October 1, 2013. Retrieved October 1, 2013.
  11. ^ Lee JU, Shin W, Son JY, Yoo KY, Heo YS (January 2017). "Molecular Basis for the Neutralization of Tumor Necrosis Factor α by Certolizumab Pegol in the Treatment of Inflammatory Autoimmune Diseases". Int J Mol Sci. 18 (1): 228. doi:10.3390/ijms18010228. PMC 5297857. PMID 28124979.
  12. ^ a b 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
  13. ^ 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
  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 2020-03-29. Retrieved 2009-11-15.
  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.
  16. ^ a b Ruiz Garcia, V; Jobanputra, P; Burls, A; Vela Casasempere, P; Bort-Marti, S; Bernal, JA (Sep 8, 2017). "Certolizumab pegol (CDP870) for rheumatoid arthritis in adults" (PDF). The Cochrane Database of Systematic Reviews. 2017 (9): CD007649. doi:10.1002/14651858.CD007649.pub4. PMC 6483724. PMID 28884785.

External links[edit]