Golimumab

Golimumab
Cartoon representation of the antibody Golimumab. The heavy and light chains are coloured blue and yellow respectively. From PDB entry 5yoy
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTNFα
Names
Trade namesSimponi, Simponi Aria
Other namesCNTO-148[1]
Clinical data
Main usesRheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis[2][3]
Side effectsUpper respiratory tract infection[3]
Pregnancy
category
  • AU: C
  • US: N (Not classified yet)
    Routes of
    use    		Subcutaneous injection
    External links
    AHFS/Drugs.comMonograph
    US NLMGolimumab
    MedlinePlusa610010
    Legal
    License data
    Legal status
    Chemical and physical data
    FormulaC6530H10068N1752O2026S44
    Molar mass146945.25 g·mol−1

    Golimumab, sold under the brand name Simponi, is a medication used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.[2][3] It is given by injection under the skin.[2]

    Common side effects include upper respiratory tract infection.[3] Other side effects may include sepsis, pneumonia, reactivation of hepatitis B, heart failure, allergic reactions, vasculitis, and leukemia.[3] Use in pregnancy and breastfeeding is of unclear safety.[6] It is a monoclonal antibody which is attaches to and blocks tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule.[3]

    Golimumab was approved for medical use in the United States and Europe in 2009.[2][3] It is on the World Health Organization's List of Essential Medicines as an alternative to adalimumab.[7] In the United Kingdom 100 mg costs the NHS about £1,500 as of 2021.[8] In the United States this amount costs about 6,300 USD.[9]

    Medical uses

    It is used to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[3][10] It is also used to treat ulcerative colitis.[11][12] Golimumab can either be used via a self administered subcutaneous injection or intravenous injection.[13]

    Golimumab is approved in Canada[14] and the United States[15] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis.[16][17]

    Dosage

    The typical dose is 50 to 100 mg per month.[8]

    History

    Golimumab binds to both soluble and transmembrane forms of TNFα. The antibody was isolated from a hybridoma clone produced by transgenic mice immunized with human TNFα. The golimumab-secreting clone was selected after being assayed for human light and heavy chains and TNFα-binding. The commercial product is produced in a recombinant cell line cultured by continuous perfusion.[18]

    Society and culture

    Golimumab was developed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.[19]

    Research

    Rheumatoid arthritis

    Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone.[20] When clinically indicated, golimumab is estimated as a moderate cost-effective treatment option. National Institutes for Health and Care Excellence (NICE) stated that treatment with golimumab is not recommended for RA patients who have failed prior TNFi treatment.[21] Unlike other TNFi treatments such as adalimumab and certolizumab pegol, there have been no reported cases of drug-induced lupus-like syndrome (DILS).[22]

    Uveitis

    There is preliminary evidence for golimumab as a treatment option for ocular inflammation.[23]

    References

    1. ↑ Mazumdar S, Greenwald D (2009). "Golimumab". mAbs. 1 (5): 422–31. doi:10.4161/mabs.1.5.9286. PMC 2759491. PMID 20065639. Archived from the original on 2014-08-08. Retrieved 2021-10-04.
    2. 1 2 3 4 "Golimumab Monograph for Professionals". Drugs.com. Archived from the original on 9 July 2018. Retrieved 9 December 2021.
    3. 1 2 3 4 5 6 7 8 9 "Simponi EPAR". European Medicines Agency (EMA). Archived from the original on 11 November 2020. Retrieved 11 November 2020.
    4. ↑ "Simponi- golimumab injection, solution". DailyMed. 30 September 2019. Archived from the original on 25 March 2021. Retrieved 11 November 2020.
    5. ↑ "Simponi Aria- golimumab solution". DailyMed. 2 October 2020. Archived from the original on 24 March 2021. Retrieved 11 November 2020.
    6. ↑ "Golimumab Use During Pregnancy". Drugs.com. Archived from the original on 29 October 2020. Retrieved 9 December 2021.
    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. 1 2 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1162. ISBN 978-0857114105.
    9. ↑ "Simponi Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 20 January 2021. Retrieved 9 December 2021.
    10. ↑ "Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis". www.drugs.com. Archived from the original on 2011-06-07. Retrieved 2016-05-09.
    11. ↑ Löwenberg M, de Boer NK, Hoentjen F (2014-03-12). "Golimumab for the treatment of ulcerative colitis". Clinical and Experimental Gastroenterology. 7: 53–9. doi:10.2147/CEG.S48741. PMC 3958527. PMID 24648749.
    12. ↑ "Johnson & Johnson Reports 2008 First-Quarter Results". Archived from the original on 2008-10-07. Retrieved 2008-04-28.
    13. ↑ Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. (March 2014). "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update". Annals of the Rheumatic Diseases. 73 (3): 492–509. doi:10.1007/s13554-013-0012-y. PMC 4079096. PMID 24161836.
    14. ↑ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis". Archived from the original on 2010-02-02.
    15. ↑ "FDA Approves Simponi". Archived from the original on 2011-06-07. Retrieved 2021-10-04.
    16. ↑ "FDA clears potential blockbuster arthritis drug". North County Times. Lee Enterprises. Associated Press. 24 April 2009. Archived from the original on 14 September 2022. Retrieved 23 October 2010.
    17. ↑ Maxwell LJ, Zochling J, Boonen A, Singh JA, Veras MM, Tanjong Ghogomu E, et al. (April 2015). "TNF-alpha inhibitors for ankylosing spondylitis". The Cochrane Database of Systematic Reviews. 4 (4): CD005468. doi:10.1002/14651858.CD005468.pub2. PMID 25887212. Archived from the original on 2020-09-20. Retrieved 2021-10-04.
    18. ↑ Mazumdar S, Greenwald D (2009). "Golimumab". mAbs. 1 (5): 422–31. doi:10.4161/mabs.1.5.9286. PMC 2759491. PMID 20065639.
    19. ↑ "SIMPONI Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis | Johnson & Johnson". www.jnj.com. Archived from the original on 2016-05-19. Retrieved 2016-05-09.
    20. ↑ Oldfield V, Plosker GL (2009). "Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis". BioDrugs. 23 (2): 125–35. doi:10.2165/00063030-200923020-00005. PMID 19489653.
    21. ↑ Tosh J, Archer R, Davis S, Stevenson M, Stevens JW (August 2013). "Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs: a NICE single technology appraisal". PharmacoEconomics. 31 (8): 653–61. doi:10.1007/s40273-013-0052-7. PMID 23576019. S2CID 23085023.
    22. ↑ Williams VL, Cohen PR (May 2011). "TNF alpha antagonist-induced lupus-like syndrome: report and review of the literature with implications for treatment with alternative TNF alpha antagonists". International Journal of Dermatology. 50 (5): 619–25. doi:10.1111/j.1365-4632.2011.04871.x. PMID 21506984. S2CID 21538173.
    23. ↑ Rifkin LM, Birnbaum AD, Goldstein DA (August 2013). "TNF inhibition for ophthalmic indications: current status and outlook". BioDrugs. 27 (4): 347–57. doi:10.1007/s40259-013-0022-9. PMID 23568177. S2CID 391892.
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