Certolizumab pegol explained

Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical 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

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

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.

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.[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]

Notes and References

  1. Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S . 6 . Certolizumab pegol for the treatment of Crohn's disease . The New England Journal of Medicine . 357 . 3 . 228–238 . July 2007 . 17634458 . 10.1056/NEJMoa067594 . free .
  2. Goel N, Stephens S . Certolizumab pegol . mAbs . 2 . 2 . 137–147 . 2010 . 20190560 . 2840232 . 10.4161/mabs.2.2.11271 .
  3. Kaushik VV, Moots RJ . CDP-870 (certolizumab) in rheumatoid arthritis . Expert Opinion on Biological Therapy . 5 . 4 . 601–606 . April 2005 . 15934837 . 10.1517/14712598.5.4.601 . 21974683 .
  4. Web site: Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160 . U.S. Food and Drug Administration (FDA) . December 24, 1999 . July 18, 2020.
  5. Web site: Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution . DailyMed . April 24, 2020 . July 18, 2020.
  6. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 22nd list (2021) . 2021 . 10665/345533 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2021.02 . free .
  7. Web site: Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease . UCB press release . https://web.archive.org/web/20120218234442/http://www.ucb.com/media-room/newsdetail/?det=1314787 . February 18, 2012 . April 22, 2008 .
  8. Web site: FDA Approvals: Patanase, Actonel, Cimzia . Waknine Y . May 1, 2008 . . May 1, 2008.
  9. Web site: Cimzia European Public Assessment Report . . November 15, 2009 . https://web.archive.org/web/20091109064625/http://www.emea.europa.eu/humandocs/Humans/EPAR/cimzia/cimzia.htm . November 9, 2009 . dead .
  10. Web site: Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis . October 1, 2013 . dead . https://archive.today/20131001130038/http://www.ucb.presscentre.com/News/Cimzia-certolizumab-pegol-approved-by-the-U-S-FDA-for-treatment-of-adult-patients-with-active-ps-45c.aspx . October 1, 2013 .
  11. Schreiber S, Khaliq-Kareemi M, Lawrance I, Hanauer S, McColm J, Bloomfield R, Sandborn W . 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 . suppl 7 . A82 .
  12. Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, McColm JA, Innes A, Schreiber S . 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 . 4 . A107 .
  13. New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn's Disease. October 23, 2006. UCB. November 15, 2009. March 29, 2020. https://web.archive.org/web/20200329052421/http://ir.ucb-group.com/phoenix.zhtml?c=137495&p=irol-newsArticle&ID=919693. dead.
  14. Sieper J, Tubergen A, Coteur G, Woltering F, Landewe R . 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. May 2013. Value in Health. 16. 3. A227. 10.1016/j.jval.2013.03.1150. free.
  15. Ruiz Garcia V, Burls A, Cabello JB, Vela Casasempere P, Bort-Marti S, Bernal JA . Certolizumab pegol (CDP870) for rheumatoid arthritis in adults . The Cochrane Database of Systematic Reviews . 2017 . 9 . CD007649 . September 2017 . 28884785 . 6483724 . 10.1002/14651858.CD007649.pub4 .

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