Certolizumab pegol

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Certolizumab pegol
CertolizumaB 5WUV.png
Syringe with Certolizumab pegol-1800.jpg
Syringe with 200mg certolizumab pegol
Monoclonal antibody
TypeFab' fragment
SourceHumanized (from mouse)
TargetTNF alpha
Names
Trade namesCimzia
Other namesCDP870
Clinical data
Drug classTNF inhibitor[1]
Main usesCrohn's disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis[1]
Side effectsInfections, low white blood cells, nausea, headache, numbness, high blood pressure, liver inflammation, rash, pain at the site of injection[2]
Pregnancy
category
  • AU: C
  • US: N (Not classified yet)
Routes of
use
Subcutaneous
External links
AHFS/Drugs.comMonograph
US NLMCertolizumab pegol
MedlinePlusa608041
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Pharmacokinetics
Elimination half-lifeabout 11 days
ExcretionKidney (PEG only)
Chemical and physical data
FormulaC2115H3252N556O673S16
Molar mass47749.46 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Certolizumab pegol, sold under the brand name Cimzia, is a medication used to treat Crohn's disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.[1] It is given by injection under the skin.[3]

Common side effects include infections such as abscesses, low white blood cells, nausea, headache, numbness, high blood pressure, liver inflammation, rash, and pain at the site of injection.[2] Other side effects may include cancer, heart failure, and angioedema.[3] It is a fragment of a monoclonal antibody that binds to tumor necrosis factor alpha (TNF-α).[3]

Certolizumab pegol was approved for medical use in the United States in 2008 and Europe in 2009.[1][2] It is on the World Health Organization's List of Essential Medicines as an alternative to adalimumab.[4] In the United Kingdom 400 mg costs the NHS about £715 as of 2021.[5] This amount in the United States costs about 4,700 USD.[6]

Medical uses

Crohn's Disease: It is used for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.[7][8][9]

Rheumatoid arthritis[1]

Psoriatic arthritis[1]

Dosage

The initial dose is generally 400 mg followed by 400 mg at 2 and 4 weeks.[1] Doses may than be given every 4 weeks.[1]

Side effects

Significant side effects occur in 2% of people.[10]

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​.[11]

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.[12]

Research

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.[13][14][12][15][16]
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.[17]
Rheumatoid arthritis
Certolizumab appears beneficial in those with rheumatoid arthritis.[10]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". DailyMed. 24 April 2020. Retrieved 18 July 2020.
  2. 2.0 2.1 2.2 "Cimzia". Retrieved 3 January 2022.
  3. 3.0 3.1 3.2 "Certolizumab Monograph for Professionals". Drugs.com. Retrieved 3 January 2022.
  4. 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.
  5. BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1159. ISBN 978-0857114105.
  6. "Cimzia Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 3 January 2022.
  7. "Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 18 July 2020.
  8. 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.
  9. Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved 2008-05-01.
  10. 10.0 10.1 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. 2017 (9): CD007649. doi:10.1002/14651858.CD007649.pub4. PMC 6483724. PMID 28884785.
  11. 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". Int J Mol Sci. 18 (1): 228. doi:10.3390/ijms18010228. PMC 5297857. PMID 28124979.
  12. 12.0 12.1 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
  13. 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.
  14. Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". mAbs. 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
  15. 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
  16. "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 2020-03-29. Retrieved 2009-11-15.
  17. 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.

External links

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