• Giuseppe TridenteEmail author


Infliximab (Remicade ®, Janssen) is an IgG1k chimeric human-murine monoclonal antibody that specifically binds with high affinity to TNFα, and is indicated for active adult and pediatric Crohn’s disease (CD), adult and pediatric ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis (AS), plaque psoriasis (Ps), and psoriasic arthritis (PsA). Initial approval from FDA was granted in 1998 for active CD and fistulizing CD. The following year EMEA approved infliximab for the same indications under ‘exceptional circumstances’, while FDA extended authorization to active RA in association with MTX on the basis of an additional multicenter study. Initial approval from Health Canada was given in 2001 for RA and CD. FDA extended approval in 2002 for maintaining clinical remission in CD, in 2004 for AS, in 2005 for PsA and UC, in 2006 for pediatric CD and Ps, and in 2011 for pediatric UC. Meanwhile, alerts were issued by FDA on fungal infections (2008), and on increased risk of lymphoma and other cancers associated with the use of TNF blockers (including infliximab) in children and adolescents (2009).


Rheumatoid Arthritis Ulcerative Colitis Rheumatoid Arthritis Patient Ankylose Spondylitis Infusion Reaction 
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_24_MOESM1_ESM.xls (80 kb)
Supplementary material 1 (XLS 81 kb)


  1. 1.
    Infliximab (Remicade ®) BLA 98-0012. FDA Medical Review July 1998Google Scholar
  2. 2.
    Infliximab (Remicade ®) WC500050885 EMEA Scientific Discussion, 2005Google Scholar
  3. 3.
    Infliximab (Remicade ®) WC500051557 EMEA Assessment Report, Feb 2007Google Scholar
  4. 4.
    Infliximab (Remicade ®) WC5000106936 EMEA Assessment Report, Mar 2011Google Scholar
  5. 5.
    Infliximab (Remicade ®) Product Information, Centocor 1998, Janssen 2011Google Scholar
  6. 6.
    Infliximab (Remicade ®) WC500124425 EMEA Assessment Report, Jan 2012Google Scholar
  7. 7.
    Infliximab (Remicade ®) WC 500050888 EMEA Annex I, Mar 2012Google Scholar
  8. 8.
    Tracey D, Klareskob L, Sasso EH et al (2008) Tumor necrosis factor antagonist mechanism of action: a comprehensive review. Pharmacol Ther 117:244–279PubMedCrossRefGoogle 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.
    Van Deventer SJH (1999) Review article: targeting TNFα as a key cytokine in the inflammatory processes of Crohn’s disease – the mechanism of action of infliximab. Aliment Pharmacol Ther 13(s4): 3–8Google Scholar
  11. 11.
    Molloy JW, Stengel JZ, Arnold HL (2009) Infliximab: a review of its use in the treatment of Crohn’s disease. Clin Med: Therapeutics 1:1351–1365Google Scholar
  12. 12.
    Lawlor G, Moss AC (2009) Cause for controversy? Infliximab in the treatment of ulcerative colitis: an update. Exp Clin Gastroenterol 2:149–161CrossRefGoogle Scholar
  13. 13.
    Miehsler W, Novacek G, Wenzl H et al (2010) A decade of infliximab: the Austrian evidence based consensus on the safe use of infliximab in inflammatory bowel disease. J Crohn Colitis 4:221–256CrossRefGoogle Scholar
  14. 14.
    Rutgeerts P, Sandborn WJ, Feagan BG et al (2005) Infliximab for induction and maintenance therapy for ulcerative colitis. NEJM 353:2462–2476PubMedCrossRefGoogle Scholar
  15. 15.
    De Vries MK, Wolbink GJ, Stapel SO et al (2007) Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis 66:1252–1254PubMedCrossRefGoogle Scholar
  16. 16.
    Aaltonen KJ, Virkki LM, Malmivaara A et al (2012) Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS ONE 7:1–14 (e30275)Google Scholar
  17. 17.
    Poggioli G, Laureti S, Campieri M et al (2007) Infliximab in the treatment of Chron’s disease. Ther Clin Risk Manag 3:301–308PubMedCrossRefGoogle Scholar
  18. 18.
    Van der Hijde D, Dijkmans B, Geusens P et al (2005) Efficacy and safety of infliximab in patients with ankylosing spondylitis. Arthr Rheum 52:582–591CrossRefGoogle Scholar
  19. 19.
    Rustin MHA (2012) Long-term safety of biologics in the treatment of moderate-to-severe plaque psoriasis: review of current data. BJD 167(s3):3–11Google Scholar
  20. 20.
    Boehncke W-H, Prinz J, Gottlieb B (2012) Biologic therapies for psoriasis: a systematic review. J Rheumatol 33:1447–1451Google Scholar
  21. 21.
    Feletar M, Brockbank JE, Schentag CT et al (2004) Treatment of refractory psoriasis with infliximab: a 12 month observational study of 16 patients. Ann Rheum Dis 63:156–161PubMedCrossRefGoogle Scholar
  22. 22.
    Tristano AG (2010) Neurological adverse events associated with anti-tumor necrosis factor alpha treatment. J Neurol 257:1421–1431PubMedCrossRefGoogle Scholar
  23. 23.
    Pham T, Bachelez H, Berthelot J-M et al (2011) TNF alpha antagonist therapy and safety monitoring. Joint Bone Spine 78(S1):15-185. doi:  10.1016/S1297-319X (11)70001-x
  24. 24.
    Ochenrider MG, Patterson DJ, Aboulafia DM (2010) Hepatosplenic T-cell lymphoma in a young man with Chron’s disease: case report and literature review. Clin Lymphoma, Myeloma & Leukemia 10:144–148CrossRefGoogle Scholar
  25. 25.
    Bessisow T, Renard M, Hoffman I et al (2012) Review article: non-malignant haematological complications of anti-tumour necrosis factor alpha therapy. Aliment Pharmacol Ther 36:312–323CrossRefGoogle Scholar
  26. 26.
    Comarmord C, Plaisier E, Dahan K et al (2012) Anti-TNF-α in refractory Takayasu’s arteritis: cases series and review of the literature. Autoimmun Rev 11(2012):678–684CrossRefGoogle Scholar
  27. 27.
    Elder JT (2009) Genome-wide association scan yields new insight into the immunopathogenesis of psoriasis. Genes Immun 10:201–2019PubMedCrossRefGoogle Scholar
  28. 28.
    Alexis AF, Strober BE (2005) Off-label dermatologic uses of anti-TNF-a therapies. J Cutan Med Surg 9:296–302PubMedCrossRefGoogle Scholar
  29. 29.
    Couriel D, Saliba R, Hicks K et al (2004) Tumor necrosis factor-α blockade for the treatment of acute GVHD. Blood 104:649–654PubMedCrossRefGoogle Scholar
  30. 30.
    Mirshahi A, Hoehn R, Lorenz K et al (2012) Anti-tumor necrosis factor alpha for retinal diseases: current knowledge and future concepts. J Ophthalmic Vis Res 7:39–44PubMedGoogle Scholar
  31. 31.
    Matsuda J, Kaburaki T, Kobayashi S et al (2012) Treatment of recurrent anterior uveitis with infliximab in patient with ankylosing spondylitis. Jpn J Ophtalmol. doi: 10.1007/s10384-012-0202-z Google Scholar
  32. 32.
    Yeh S, Albini TA, Moshfeghi AA et al (2012) Uveitis, the comparison of age-related macular degeneration treatments trials (CATT), and intravitreal biologics for ocular inflammation. Am J Ophthalmol 154:429–435PubMedCrossRefGoogle Scholar
  33. 33.
    Smolen JS, Emery P (2011) Infliximab: 12 years of experience. Arthr Res Ther 13: 52–69Google Scholar
  34. 34.
    Diaz-Lagares C, Peréz-Alvarez R, García-Hernández FJ et al (2011) Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label. Arthritis Res Ther 13:R112PubMedCrossRefGoogle Scholar
  35. 35.
    Maneiro JR, Salgado E, Gomez-Reino JJ et al (2012) Efficacy and safety of TNF antagonists in sarcoidosis: data from the Spanish Registry of Biologics BIOBADASER and a systematic review. Semin Arthritis Rheum 42:89–103Google Scholar
  36. 36.
    Cuchacovich R, Espinoza CG, Virk Z et al (2008) Biologic therapy (TNF-alpha antagonists)-induced psoriasis: a cytokine imbalance between TNF-alpha and IFN-alpha? J Clin Rheumatol 14:353–356PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

Personalised recommendations