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Golimumab (CNTO 148)[1] is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[2] and hence is a TNF inhibitor. Profound reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellaular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism.[3]

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.[4]

Development

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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.[5]

Uses

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European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[6] Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[7].[8] Golimumab can either be used via a self administered subcutaneous injection or intravenous injection .[9]

Golimumab is approved in Canada[10] and the United States[11] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.[12][13]

Clinical trials

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Rheumatoid arthritis

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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.[14] When clinically indicated, golimumab is estimated as a moderate cost-effective treatment option. National Institutes for Health and Clinical Excellence (NICE) stated that treatment with golimumab is not recommended for RA patients who have failed prior TNFi treatment.[15] Unlike other TNFi treatments such as adalimumab and certolizumab pegol, there have been no reported cases of drug-induced lupus-like syndrome (DILS).[16]

Uveitis

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There is preliminary evidence for golimumab as a treatment option for ocular inflammation.[17]

  1. ^ Mazumdar, Sohini; David Greenwald (2009). "Golimumab". MAbs. 1 (5): 422–431. doi:10.4161/mabs.1.5.9286.
  2. ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab, American Medical Association.
  3. ^ Rossini, Maurizio; Vita, Salvatore De; Ferri, Clodoveo; Govoni, Marcello; Paolazzi, Giuseppe; Salvarani, Carlo; Adami, Silvano (2013-12-01). "Golimumab: A Novel Anti-Tumor Necrosis Factor". Biologics in Therapy. 3 (2): 83–107. doi:10.1007/s13554-013-0012-y. ISSN 2195-5840. PMC 4079096.{{cite journal}}: CS1 maint: PMC format (link)
  4. ^ "SIMPONI® Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis | Johnson & Johnson". www.jnj.com. Retrieved 2016-05-09.
  5. ^ Mazumdar, S; Greenwald, D (2009). "Golimumab". MAbs. 1 (5): 422–431. PMC 2759491. PMID 20065639.
  6. ^ "Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis". www.drugs.com. Retrieved 2016-05-09.
  7. ^ Löwenberg, Mark; de Boer, Nanne KH; Hoentjen, Frank (2014-03-12). "Golimumab for the treatment of ulcerative colitis". Clinical and Experimental Gastroenterology. 7: 53–59. doi:10.2147/CEG.S48741. ISSN 1178-7023. PMC 3958527. PMID 24648749.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  8. ^ Johnson & Johnson Reports 2008 First-Quarter Results
  9. ^ Rossini, Maurizio; Vita, Salvatore De; Ferri, Clodoveo; Govoni, Marcello; Paolazzi, Giuseppe; Salvarani, Carlo; Adami, Silvano (2013-12-01). "Golimumab: A Novel Anti-Tumor Necrosis Factor". Biologics in Therapy. 3 (2): 83–107. doi:10.1007/s13554-013-0012-y. ISSN 2195-5840. PMC 4079096.{{cite journal}}: CS1 maint: PMC format (link)
  10. ^ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis".
  11. ^ FDA Approves Simponi
  12. ^ "FDA clears potential blockbuster arthritis drug". North County Times. Lee Enterprises. Associated Press. 24 April 2009. Retrieved 23 October 2010.[permanent dead link‍]
  13. ^ Maxwell, LJ; Zochling, J; Boonen, A; Singh, JA; Veras, MM; Tanjong Ghogomu, E; Benkhalti Jandu, M; Tugwell, P; Wells, GA (18 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.
  14. ^ Oldfield, Vicki; Plosker, Greg L. (2009). "Golimumab". BioDrugs. 23 (2): 125. doi:10.2165/00063030-200923020-00005. PMID 19489653.
  15. ^ Tosh, Jonathan; Archer, Rachel; Davis, Sarah; Stevenson, Matt; Stevens, John W. (2013-08-01). "Golimumab for the Treatment of Rheumatoid Arthritis After the Failure of Previous Disease-Modifying Antirheumatic Drugs: A NICE Single Technology Appraisal". PharmacoEconomics. 31 (8): 653–661. doi:10.1007/s40273-013-0052-7. ISSN 1170-7690.
  16. ^ Williams, L., Victoria (2011). "TNF alpha antagonist-induced lupus-like syndrome: report and review of the literature with implications for treatment with alternative TNF alpha antagonists". Pharmacology and therapeutics. 50: 619–625.
  17. ^ Rifkin, Lana M.; Birnbaum, Andrea D.; Goldstein, Debra A. (2013-08-01). "TNF Inhibition for Ophthalmic Indications: Current Status and Outlook". BioDrugs. 27 (4): 347–357. doi:10.1007/s40259-013-0022-9. ISSN 1173-8804.
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