Suggested literature

  1. Bendtzen K. Personalized Medicine: Theranostics (therapeutics diagnostics) essential for rational use of tumor necrosis factor-alpha antagonists. Discovery Medicine, 15(83), 201-211 (2013).
  2. Bendtzen K. Is there a need for immunopharmacologic guidance of anti-tumor necrosis factor therapies? Arthritis Rheum. 63(4):867-870 (2011).
  3. Bendtzen K, Ainsworth M, Steenholdt C, Thomsen OO, Brynskov J. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies. Scand J Gastroenterol. 44, 774-781 (2009).
  4. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm Labels information of individual TNF-inhibitors.
  5. EMA Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. EMA/CHMP/BMWP/86289/2010 (2012)
  6. EMA Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins EMEA/CHMP/BMWP/14327/2006. (2008)
  7. FDA Guidance for Industry. CDER/CBER. Assay Development for Immunogenicity Testing of Therapeutic Proteins. Draft guidance (2009).
  8. Jani M, Barton A, Warren RB, Griffiths CE, Chinoy H. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford). 2013 Aug 14.
  9. Lallemand C, Kavrochorianou A, Steenholdt C, Bendtzen K, Ainsworth MA, Meritet J-F, Blanchard B, Lebon P, Taylor P, Charles P, Alzabin S, Tovey MG. Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNFalpha antagonists. J Immunol Meth. 373, 229-239 (2011).
  10. Garcês S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis. Dec 1;72(12):1947-55 (2013).
  11. Garcês S, Antunes M, Benito-Garcia E, da Silva JC, Aarden L, Demengeot J. A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies. Ann Rheum Dis. May 11. (2013)
  12. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. Feb;117(2):244-79. (2008)
  13. Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis. 72:165–178 (2013).
Acute test