Individual medicine in inflammatory bowel disease: Monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies

References

• van Deventer SJH. Tumour necrosis factor and Crohn's disease. Gut 1997; 40: 443–8
   PubMed Web of Science ®Google Scholar
• Feldmann M, Taylor P, Paleolog E, Brennan FM, Maini RN. Anti-TNF alpha therapy is useful in rheumatoid arthritis and Crohn's disease: analysis of the mechanism of action predicts utility in other diseases. Transplant Proc 1998; 30: 4126–7
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet 2007; 369: 1641–57
   PubMed Web of Science ®Google Scholar
• Elliott MJ, Maini RN, Feldmann M, Long-Fox A, Charles P, Bijl H, et al. Repeated therapy with monoclonal antibody to tumour necrosis factor a (cA2) in patients with rheumatoid arthritis. Lancet 1994; 344: 1125–7
   PubMed Web of Science ®Google Scholar
• van Dullemen HM, van Deventer SJH, Hommes DW, Bijl HA, Jansen J, Tytgat GNJ, et al. Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology 1995; 109: 129–35
   PubMed Web of Science ®Google Scholar
• Han PD, Cohen RD. Managing immunogenic responses to infliximab: treatment implications for patients with Crohn's disease. Drugs 2004; 64: 1767–77
   PubMed Web of Science ®Google Scholar
• Tangri S, Mothe BR, Eisenbraun J, Sidney J, Southwood S, Briggs K, et al. Rationally engineered therapeutic proteins with reduced immunogenicity. J Immunol 2005; 174: 3187–96
   PubMed Web of Science ®Google Scholar
• Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005; 36: 3–10
   PubMed Web of Science ®Google Scholar
• Cheifetz A, Mayer L. Monoclonal antibodies, immunogenicity, and associated infusion reactions. Mt Sinai J Med 2005; 72: 250–6
   PubMed Web of Science ®Google Scholar
• De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol 2007; 28: 482–90
   PubMed Web of Science ®Google Scholar
• Bendtzen K. Immunogenicity of anti-TNF antibodies. Immunogenicity of biopharmaceuticals, M van de Weert, EH Møller. Springer, Heidelberg 2008; VIII: 189–203
   Google Scholar
• European Medicines Agency (EMEA). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Available at, , www.emea.europa.eu/pdfs/human/biosimilar/1432706enfin.pdf. 2008;1–18.
   Google Scholar
• Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, et al. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001; 121: 1088–94
   PubMed Web of Science ®Google Scholar
• Brynskov J, Foegh P, Pedersen G, Ellervik C, Kirkegaard T, Bingham A, et al. Tumour necrosis factor a converting enzyme (TACE) activity in the colonic mucosa of patients with inflammatory bowel disease. Gut 2002; 51: 37–43
   PubMed Web of Science ®Google Scholar
• Baert F, Noman M, Vermeire S, Van Assche G G DH, Carbonez A, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348: 601–8
   PubMed Web of Science ®Google Scholar
• Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol 2006; 4: 1248–54
   PubMed Web of Science ®Google Scholar
• Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum 2006; 54: 3782–9
   PubMed Web of Science ®Google Scholar
• Wolbink GJ, Vis M, Lems W, Voskuyl AE, de Groot E, Nurmohamed MT, et al. Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006; 54: 711–5
   PubMed Web of Science ®Google Scholar
• de Vries MK, Wolbink GJ, Stapel SO, de Vrieze H, van Denderen JC, Dijkmans BA, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis 2007; 66: 1252–4
   PubMed Web of Science ®Google Scholar
• Bender NK, Heilig CE, Droll B, Wohlgemuth J, Armbruster FP, Heilig B. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int 2007; 27: 269–74
   PubMed Web of Science ®Google Scholar
• Radstake, TRDJ, Svenson, M, Eijsbouts, AM, van den Hoogen, FHJ, Enevold, C, van Riel, PLCM, , et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2008; Epub ahead of print.
   Web of Science ®Google Scholar
• Van Assche G, Magdelaine-Beuzelin C, D'Haens G, Baert F, Noman M, Vermeire S, et al. Withdrawal of immunosuppression in Crohn's disease treated with scheduled infliximab maintenance: a randomized trial. Gastroenterology 2008; 134: 1861–8
   PubMed Web of Science ®Google Scholar
• West, RL, Zelinkova, Z, Wolbink, GJ, Kuipers, EJ, Stokkers, PC, Van Derw, CJ. Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease. Aliment Pharmacol Ther 2008; Epub ahead of print.
   Web of Science ®Google Scholar
• Gudbrandsdottir S, Larsen R, Sorensen LK, Nielsen S, Hansen MB, Svenson M, et al. TNF and LT binding capacities in the plasma of arthritis patients: effect of etanercept treatment in juvenile idiopathic arthritis. Clin Exp Rheumatol 2004; 22: 118–24
   PubMed Web of Science ®Google Scholar
• Svenson M, Geborek P, Saxne T, Bendtzen K. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology 2007; 46: 1828–34
   PubMed Web of Science ®Google Scholar
• Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn's disease. Am J Gastroenterol 2008; 103: 944–8
   PubMed Web of Science ®Google Scholar
• Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol 2004; 251(Suppl 2)II4–9
   PubMedGoogle Scholar
• Teillaud JL. Engineering of monoclonal antibodies and antibody-based fusion proteins: successes and challenges. Expert Opin Biol Ther 2005; 5(Suppl 1)S15–27
   PubMed Web of Science ®Google Scholar
• Watier H. Variability factors in the clinical response to recombinant antibodies and IgG Fc-containing fusion proteins. Expert Opin Biol Ther 2005; 5(Suppl 1)S29–36
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Wagner CL, Bala M, Mayer L, Travers S, Diamond RH, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004; 2: 542–53
   PubMed Web of Science ®Google Scholar
• Vermeire S, Noman M, Van Assche G, Baert F, D'Haens G, Rutgeerts P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007; 56: 1226–31
   PubMed Web of Science ®Google Scholar
• Bendtzen K. Anti-IFN BAb and NAb antibodies: A mini review. Neurology 2003; 61(Suppl 5)S6–10
   PubMed Web of Science ®Google Scholar
• Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004; 93: 2645–68
   PubMed Web of Science ®Google Scholar
• Hansen KE, Hildebrand JP, Genovese MC, Cush JJ, Patel S, Cooley DA, et al. The efficacy of switching from etanercept to infliximab in patients with rheumatoid arthritis. J Rheumatol 2004; 31: 1098–102
   PubMed Web of Science ®Google Scholar
• Haraoui B, Keystone EC, Thorne JC, Pope JE, Chen I, Asare CG, et al. Clinical outcomes of patients with rheumatoid arthritis after switching from infliximab to etanercept. J Rheumatol 2004; 31: 2356–9
   PubMed Web of Science ®Google Scholar
• Solau-Gervais E, Laxenaire N, Cortet B, Dubucquoi S, Duquesnoy B, Flipo RM. Lack of efficacy of a third tumour necrosis factor alpha antagonist after failure of a soluble receptor and a monoclonal antibody. Rheumatology (Oxford) 2006; 45: 1121–4
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007; 146: 829–38
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541–9
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006; 130: 323–3
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Hanauer SB, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh DG, et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007; 56: 1232–9
   PubMed Web of Science ®Google Scholar
• Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007; 132: 52–65
   PubMed Web of Science ®Google Scholar
• Clark M, Colombel JF, Feagan BC, Fedorak RN, Hanauer SB, Kamm MA, et al. American gastroenterological association consensus development conference on the use of biologics in the treatment of inflammatory bowel disease, June 21–23, 2006. Gastroenterology 2007; 133: 312–39
   PubMed Web of Science ®Google Scholar
• Maini SR. Infliximab treatment of rheumatoid arthritis. Rheum Dis Clin North Am 2004; 30: 329–47
   PubMed Web of Science ®Google Scholar