Certolizumab

Certolizumab pegol

Certolizumab pegol

Pharmaceutical drug

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]

Quick Facts Monoclonal antibody, Type ...

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

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.[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

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

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

  1. [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. [2]
    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. [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. [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. [5]
    "Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160". U.S. Food and Drug Administration (FDA). December 24, 1999. Retrieved July 18, 2020.
  6. [6]
    "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". DailyMed. April 24, 2020. Retrieved July 18, 2020.
  7. [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. [8]
    "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.
  9. [9]
    Waknine Y (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved May 1, 2008.
  10. [10]
    "Cimzia European Public Assessment Report". European Medicines Agency. Archived from the original on November 9, 2009. Retrieved November 15, 2009.
  11. [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. [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. [13]
    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. [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. [15]
    "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.
  16. [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. [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.
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