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Certolizumab pegol

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Certolizumab pegol
Monoclonal antibody
TypeFab' fragment
SourceHumanized (from mouse)
TargetTNF alpha
Clinical data
Trade namesCimzia
AHFS/Drugs.comConsumer Drug Information
MedlinePlusa608041
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-lifeabout 11 days
ExcretionRenal (PEG only)
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2115H3252N556O673S16
Molar mass47,750 g/mol g·mol−1
 ☒NcheckY (what is this?)  (verify)

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

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.[5][7][8]
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.[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

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.[11]

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.[3][11][12][13]
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.[14]
Rheumatoid arthritis
Certolizumab appears beneficial in those with rheumatoid arthritis.[15]

Side effects

Significant side effects occur in 2% of people who take the medication.[15]

References

Template:Research help

  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 22 Oct 2023.
  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. ^ 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.
  4. ^ 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.
  5. ^ a b index.cfm?fuseaction=Search.Label_ApprovalHistory "Cimzia Label and Approval History". Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 2009-11-15. {{cite web}}: Check |url= value (help)
  6. ^ "Cimzia Prescribing Information" (PDF). US Food and Drug Administration (FDA). April 2016. Retrieved 2016-08-21.
  7. ^ UCB press release - Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. 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. Retrieved November 15, 2009.
  10. ^ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Retrieved October 1, 2013.
  11. ^ 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
  12. ^ 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
  13. ^ "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.
  14. ^ 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.
  15. ^ a b 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.
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