Golimumab

Compound Name:GolimumabMolecular Target:TNF? (Tumor Necrosis Factor-alpha)Molecular Structure:human IgG1?, recombinantLicensed Indication:Rheumatoid arthritis; Psoriatic arthritis; Ankylosing SpondylitisManufacturer and/or Distributor:Janssen BiotechInitial FDA Approval2009SummaryGolimumab (Simponi) is a recombinant human IgG1κ monoclonal antibody that binds specifically to both the soluble and transmembrane forms of TNFα, thereby preventing binding to its receptors. It is administered as a subcutaneous injection and is marketed for once-monthly administration. TNFα is a central mediator of inflammation and is known to be dysregulated in a range of autoimmune diseases. TNFα blockers are thought to provide effective immunosuppression through a variety of mechanisms: neutralization of soluble and/or membrane-bound TNFα, direct cellular toxicity via complement-mediated lysis and/or antibody-dependent cytotoxicity, and induction of apoptosis or other downregulatory effects. Golimumab was first licensed for use in the U.S. in April 2009 for the treatment of adults with rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis. An indication for ulcerative colitis was added in 2013. In June 2015, based on the data from the Phase III GO-AHEAD trial, golimumab received European Commission Approval for treatment of adults with severe active non-radiographic axial spondyloarthritis. Adverse reactions include an increased risk of infection similar to other TNF blockers (tuberculosis, invasive fungal infections, and other opportunistic pathogens including Legionella and Listeria). The concurrent administration of golimumab with anakinra or abatacept is not recommended. The use of TNF blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. The exacerbation or new onset of demyelinating diseases may occur with golimumab. Labeling also includes risk of lymphoma and other malignancies in both children and adults.References

Package Insert: http://www.simponi.com/sites/default/files/shared/product/simponi/prescribing-information.pdf

1. Braun J, Deodhar A, Inman RD, van der Heijde D, Mack M, Xu S, et al. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study. Ann Rheum Dis. 2012 May;71(5):661-667. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22012970

2. Keystone E, Genovese MC, Klareskog L, Hsia EC, Hall S, Miranda PC, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis. 2010 Jun;69(6):1129-1135.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=20444749

3. Tak PP, Kalden JR. Advances in rheumatology: new targeted therapeutics. Arthritis Res Ther. 2011;13 Suppl 1:S5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21624184

4. Ash Z, Emery P. Golimumab - a new tool in the armoury against inflammatory arthritis. Ann Med. 2011 Mar;43(2):133-141. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21244218

5. Sandborn W, Feagan B, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous Golimumab Maintains Clinical Response in Patients with Moderate-To-Severe Ulcerative Colitis. Gastroenterology. 2013 http://dx.doi.org/10.1053/j.gastro.2013.06.010

6. Akobeng AA, Sandborn WJ, Bickston SJ, Chande N, Shackelton LM, Nelson S, Feagan BG. Tumor necrosis factor-alpha antagonists twenty years later: what do cochrane reviews tell us? Inflamm Bowel Dis. 2014 Nov;20(11):2132-41. http://www.ncbi.nlm.nih.gov/pubmed/25299543

7. Caso F, Lubrano E, Del Puente A, Caso P, Peluso R et al. Progress in understanding and utilizing TNF-α inhibition for the treatment of psoriatic arthritis. Expert Rev Clin Immunol. 2015 Dec 9:1-17. http://www.ncbi.nlm.nih.gov/pubmed/26558483

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