Certolizumab pegol

Certolizumab pegol (CDP870, tradename 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]

Certolizumab pegol
Syringe with 200mg Certolizumab pegol
Monoclonal antibody
TypeFab' fragment
SourceHumanized (from mouse)
TargetTNF alpha
Clinical data
Trade namesCimzia
AHFS/Drugs.comMonograph
MedlinePlusa608041
License data
Pregnancy
category
  • US: B (No risk in non-human studies)
    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 mass47749.46 g·mol−1
     NY (what is this?)  (verify)

    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][6][7]
    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.[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.[1][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]

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    References
    1. 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.
    4. "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. 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.
    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. Archived from the original on November 9, 2009. Retrieved November 15, 2009.
    9. "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.
    10. 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.
    14. 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. 9: CD007649. doi:10.1002/14651858.CD007649.pub4. PMC 6483724. PMID 28884785.
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