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Wikipedia

Certolizumab pegol

December 14, 2023

Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease,[2][3] 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.[4][5][6]

Certolizumab pegol
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: WARNING[1]Rx-only
  • EU: Rx-only
Pharmacokinetic data
Elimination half-lifeabout 11 days
ExcretionKidney (PEG only)
Identifiers
CAS Number
  • 428863-50-7 N
DrugBank
  • DB08904 Y
ChemSpider
  • none
UNII
  • UMD07X179E
KEGG
  • D03441 Y
ChEMBL
  • ChEMBL1201831 N
Chemical and physical data
FormulaC2115H3252N556O673S16
Molar mass47749.46 g·mol−1
 NY (what is this?)  (verify)

It is on the World Health Organization's List of Essential Medicines.[7]

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.[5][8][9]
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.[10]
Psoriatic arthritis
On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.[11]

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​.[12]

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.[13]

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.[2][13][14][15]
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.[16]
Rheumatoid arthritis
Certolizumab appears beneficial in those with rheumatoid arthritis.[17]

References edit

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved October 22, 2023.
  2. ^ a b Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, et al. (July 2007). "Certolizumab pegol for the treatment of Crohn's disease". The New England Journal of Medicine. 357 (3): 228–238. doi:10.1056/NEJMoa067594. PMID 17634458.
  3. ^ Goel N, Stephens S (2010). "Certolizumab pegol". mAbs. 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
  4. ^ Kaushik VV, Moots RJ (April 2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert Opinion on Biological Therapy. 5 (4): 601–606. doi:10.1517/14712598.5.4.601. PMID 15934837. S2CID 21974683.
  5. ^ a b "Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160". U.S. Food and Drug Administration (FDA). December 24, 1999. Retrieved July 18, 2020.
  6. ^ "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". DailyMed. April 24, 2020. Retrieved July 18, 2020.
  7. ^ 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.
  8. ^ . UCB press release. Archived from the original on February 18, 2012. Retrieved April 22, 2008.
  9. ^ Waknine Y (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved May 1, 2008.
  10. ^ . European Medicines Agency. Archived from the original on November 9, 2009. Retrieved November 15, 2009.
  11. ^ "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.
  12. ^ 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". International Journal of Molecular Sciences. 18 (1): 228. doi:10.3390/ijms18010228. PMC 5297857. PMID 28124979.
  13. ^ a b Schreiber S, Khaliq-Kareemi M, Lawrance I, Hanauer S, McColm J, Bloomfield R, Sandborn W (2005). "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.
  14. ^ Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, McColm JA, Innes A, Schreiber S (2006). "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.
  15. ^ (Press release). UCB. October 23, 2006. Archived from the original on March 29, 2020. Retrieved November 15, 2009.
  16. ^ 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.
  17. ^ Ruiz Garcia V, Burls A, Cabello JB, Vela Casasempere P, Bort-Marti S, Bernal JA (September 2017). "Certolizumab pegol (CDP870) for rheumatoid arthritis in adults". The Cochrane Database of Systematic Reviews. 2017 (9): CD007649. doi:10.1002/14651858.CD007649.pub4. PMC 6483724. PMID 28884785.

External links edit

December 14, 2023
certolizumab, pegol, sold, under, brand, name, cimzia, biopharmaceutical, medication, treatment, crohn, disease, rheumatoid, arthritis, psoriatic, arthritis, ankylosing, spondylitis, fragment, monoclonal, antibody, specific, tumor, necrosis, factor, alpha, man. Certolizumab pegol sold under the brand name Cimzia is a biopharmaceutical medication for the treatment of Crohn s disease 2 3 rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha TNF a and is manufactured by UCB 4 5 6 Certolizumab pegolSyringe with 200mg Certolizumab pegolMonoclonal antibodyTypeFab fragmentSourceHumanized from mouse TargetTNF alphaClinical dataTrade namesCimziaOther namesCDP870AHFS Drugs comMonographMedlinePlusa608041License dataEU EMA by INN US DailyMed Certolizumab pegolPregnancycategoryAU CRoutes ofadministrationSubcutaneousATC codeL04AB05 WHO Legal statusLegal statusAU S4 Prescription only US WARNING 1 Rx only EU Rx onlyPharmacokinetic dataElimination half lifeabout 11 daysExcretionKidney PEG only IdentifiersCAS Number428863 50 7 NDrugBankDB08904 YChemSpidernoneUNIIUMD07X179EKEGGD03441 YChEMBLChEMBL1201831 NChemical and physical dataFormulaC 2115H 3252N 556O 673S 16Molar mass47749 46 g mol 1 N Y what is this verify It is on the World Health Organization s List of Essential Medicines 7 Contents 1 Medical uses 2 Method of action 3 Clinical trials 4 References 5 External linksMedical uses editCrohn 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 5 8 9 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 10 Psoriatic arthritis On September 27 2013 the U S FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis 11 Method of action edit nbsp 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 12 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 13 Clinical trials editCrohn 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 13 14 15 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 16 Rheumatoid arthritis Certolizumab appears beneficial in those with rheumatoid arthritis 17 References edit FDA sourced list of all drugs with black box warnings Use Download Full Results and View Query links nctr crs fda gov FDA Retrieved October 22 2023 a b Sandborn WJ Feagan BG Stoinov S Honiball PJ Rutgeerts P Mason D et al July 2007 Certolizumab pegol for the treatment of Crohn s disease The New England Journal of Medicine 357 3 228 238 doi 10 1056 NEJMoa067594 PMID 17634458 Goel N Stephens S 2010 Certolizumab pegol mAbs 2 2 137 147 doi 10 4161 mabs 2 2 11271 PMC 2840232 PMID 20190560 Kaushik VV Moots RJ April 2005 CDP 870 certolizumab in rheumatoid arthritis Expert Opinion on Biological Therapy 5 4 601 606 doi 10 1517 14712598 5 4 601 PMID 15934837 S2CID 21974683 a b Drug Approval Package Cimzia Certolizumab Pegol NDA 125160 U S Food and Drug Administration FDA December 24 1999 Retrieved July 18 2020 Cimzia certolizumab pegol kit Cimzia certolizumab pegol injection solution DailyMed April 24 2020 Retrieved July 18 2020 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 Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn s Disease UCB press release Archived from the original on February 18 2012 Retrieved April 22 2008 Waknine Y May 1 2008 FDA Approvals Patanase Actonel Cimzia Medscape Retrieved May 1 2008 Cimzia European Public Assessment Report European Medicines Agency Archived from the original on November 9 2009 Retrieved November 15 2009 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 Lee JU Shin W Son JY Yoo KY Heo YS January 2017 Molecular Basis for the Neutralization of Tumor Necrosis Factor a by Certolizumab Pegol in the Treatment of Inflammatory Autoimmune Diseases International Journal of Molecular Sciences 18 1 228 doi 10 3390 ijms18010228 PMC 5297857 PMID 28124979 a b Schreiber S Khaliq Kareemi M Lawrance I Hanauer S McColm J Bloomfield R Sandborn W 2005 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 Sandborn WJ Feagan BG Stoinov S Honiball PJ Rutgeerts P McColm JA Innes A Schreiber S 2006 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 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 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 Ruiz Garcia V Burls A Cabello JB Vela Casasempere P Bort Marti S Bernal JA September 2017 Certolizumab pegol CDP870 for rheumatoid arthritis in adults The Cochrane Database of Systematic Reviews 2017 9 CD007649 doi 10 1002 14651858 CD007649 pub4 PMC 6483724 PMID 28884785 External links editcertolizumab pegol at the U S National Library of Medicine Medical Subject Headings MeSH Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Certolizumab pegol amp oldid 1170146997, wikipedia, wiki, book, books, library,

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