Certolizumab pegol

Certolizumab pegol
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]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: C
  • US: N (Not classified yet)
    Routes of
    use    		Subcutaneous
    External links
    AHFS/Drugs.comMonograph
    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

    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 2 3 4 5 6 7 8 "Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution". DailyMed. 24 April 2020. Archived from the original on 19 July 2020. Retrieved 18 July 2020.
    2. 1 2 3 "Cimzia". Archived from the original on 30 December 2021. Retrieved 3 January 2022.
    3. 1 2 3 "Certolizumab Monograph for Professionals". Drugs.com. Archived from the original on 22 January 2021. 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. Archived from the original on 19 July 2020. 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. Archived from the original on 2019-12-08. Retrieved 2008-05-01.
    10. 1 2 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. Archived (PDF) from the original on November 1, 2021. Retrieved October 5, 2021.
    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. 1 2 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. Archived from the original on 2012-03-23. Retrieved 2021-10-05.
    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.
    Identifiers:
    • "Certolizumab pegol". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-06-18. Retrieved 2021-10-05.
    • certolizumab+pegol at the US National Library of Medicine Medical Subject Headings (MeSH)
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