• Giuseppe Tridente


Golimumab (Simponi®, Janssen) is a human IgG1k monoclonal antibody directed to human tumor necrosis factor alpha (TNF-α), preventing the binding of TNF-α to its receptors. In 2009, FDA approved golimumab for the treatment of the following pathologies: (i) moderately to severely active rheumatoid arthritis (RA) in adults, in combination with methotrexate (MTX); (ii) active psoriatic arthritis (PsA) in adults, alone or in combination with MTX; (iii) active ankylosing spondylitis in adults (AS). In 2009 also EMEA and Health Canada granted approval for the same indications. The national Japanese Agency PMDA approved the marketing on September 2011.


Tumor Necrosis Factor Rheumatoid Arthritis Patient Tumor Necrosis Factor Inhibitor Injection Site Reaction Cutaneous Lupus Erythematosus 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Supplementary material

307171_1_En_22_MOESM1_ESM.xls (60 kb)
Supplementary material 1 (XLS 61 kb)


  1. 1.
    Golimumab (Simponi®) BLA 125289 FDA Medical Review, April 2009Google Scholar
  2. 2.
    Golimumab (Simponi®) Product Information. Janssen, Dec 2011Google Scholar
  3. 3.
    Golimumab (Simponi®) WC500052368 EMA Annex I, Sept 2012Google Scholar
  4. 4.
    Golimumab (Simponi®) SBD 120525 Health Canada, Sept 2009Google Scholar
  5. 5.
    Mazumdar S, Greenwald D (2009) Golimumab. MAbs 1:422–431PubMedCrossRefGoogle Scholar
  6. 6.
    Chrvala CA and Caspi A (2009) Simponi (golimumab) Product Profiler. P&T 34:1-29 (25GL09187)Google Scholar
  7. 7.
    Tanaka Y, Harigai M, Takeuchi T et al (2012) Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis 71:817–824PubMedCrossRefGoogle Scholar
  8. 8.
    Takeuchi T, Harigai M, Tanaka Y et al (2012) Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with diseases-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomized, double-blind, placebo controlled GO-MONO study through 24 weeks. Ann Rheum Dis. doi: 10.1136/annrheumdis-2012-201796 Google Scholar
  9. 9.
    Horiuki T, Mitoma H, Harashima S et al (2010) Transmembrane TNFα: structure, function and interaction with anti-TNF agents. Rheumatology 49:1215–1228CrossRefGoogle Scholar
  10. 10.
    Shealy D, Cai A, Staquet K et al (2010) Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α. MAbs 2:428–439Google Scholar
  11. 11.
    Keystone E, Genovese MC, Klareskog L et al (2010) Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52 week results of GO-FORWARD study. Ann Rheum Dis 69:1129–1135PubMedCrossRefGoogle Scholar
  12. 12.
    Smolen JS, Kay J, Doyle MK et al (2009) Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomized, double-blind, placebo-controlled, phase III trial. Lancet 374:210–221PubMedCrossRefGoogle Scholar
  13. 13.
    Smolen JS, Kay J, Landewé RBM et al (2012) Golimumab in patients with active rheumatoid arthritis who have previous experience with tumor necrosis factor inhibitors: results of a long-term extension of the randomized, double-blind, placebo controlled GO-AFTER study through week 160. Ann Rheum Dis 71:1671–1679PubMedCrossRefGoogle Scholar
  14. 14.
    Kavanaugh A, Van der Heijde D, McInnes IB et al (2012) Golimumab in Psoriasis Arthritis. Arthritis Rheum 64:2504–2517PubMedCrossRefGoogle Scholar
  15. 15.
    Braun J, Deodhar A, Inman RD et al (2012) Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results in the GO-RAISE study. Ann Rheum Dis 71:661–667PubMedCrossRefGoogle Scholar
  16. 16.
    Alawadhi A, Alawneh K, Alzahrani ZA (2012) The effect of neutralizing antibodies on the sustainable efficacy of biologic therapies: what’s in it for African and Middle Eastern rheumatologists. Clin Rheumatol 31:1281–1287PubMedCrossRefGoogle Scholar
  17. 17.
    Murdaca G, Colombo BM, Puppo F (2011) Emerging biological drugs: a new therapeutic approach for systemic lupus erythematosus. An update upon efficacy and adverse events. Autoimmunity Rev 11:56–60CrossRefGoogle Scholar
  18. 18.
    Wilkerson E, Hazey MA, Bahrami S et al (2012) Golimumab-exacerbated subacute cutaneous lupus erythematosus. Arch Dermatol 148:1186–1190PubMedCrossRefGoogle Scholar
  19. 19.
    Aringer M, Smolen JS (2012) Therapeutic blockade of TNF in patients with SLE – Promising or crazy? Autoimmunity Rev 11:321–325CrossRefGoogle Scholar
  20. 20.
    Cordero-Coma M, Salom D, Diaz-Llopis M et al (2011) Golimumab for uveitis. Ophthalmology 118:192.e3-4Google Scholar
  21. 21.
    Mridula W, Faez S, Papaliodis GN et al (2012) Golimumab for the treatment of refractory juvenile idiopathic arthritis-associated uveitis. J Ophtal Inflamm Infect doi: 10.1007/s12348-012-0081-y Google Scholar
  22. 22.
    Wenzel SE, Barnes PJ, Bleecker ER et al (2009) A randomized, double-blind, placebo-controlled study of tumor necrosis factor-α blockade in severe persistent asthma. Am J Respir Crit Care Med 179:549–558PubMedCrossRefGoogle Scholar
  23. 23.
    Zidi I, Bonaziz A, Mnif W et al (2011) Golimumab and malignancies: true or false association? Med Oncol 28:641–648PubMedCrossRefGoogle Scholar
  24. 24.
    Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA et al (2012) Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy. JAMA 308:898–908PubMedCrossRefGoogle Scholar
  25. 25.
    Aaltonen KJ, Virrki LM, Malmivaara A et al (2012) Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatic arthritis. PLoS ONE 7(1–14):e30275PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

Personalised recommendations