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Review

The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?

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References

  • WHO, World Health Organization. Expert Committee on Biological Standardization. Geneva. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. Available from: www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf [Last accessed 19 February 2015]
  • European Medicines Agency. Guideline on similar biological medicinal products. 2014. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf [Last accessed 16 February 2015]
  • Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood 2014;124:3191-6
  • Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014;42:177-83
  • Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014;16:22-6
  • Dorner T, Strand V, Castaneda-Hernandez G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8
  • Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. MAbs 2014;6:1163-77
  • European Medicines Agency. Committee for medicinal products for human use (CHMP). Assessment report: Remsima (infliximab). 2013. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf [Last accessed 20 August 2015]
  • Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613-20
  • Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;72:1605-12
  • De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol 2007;28:482-90
  • Allez M, Karmiris K, Louis E, et al. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. J Crohns Colitis 2010;4:355-66
  • Sauerborn M, Brinks V, Jiskoot W, et al. Immunological mechanism underlying the immune response to recombinant human protein therapeutics. Trends Pharmacol Sci 2010;31:53-9
  • Lichtenstein GR. Comprehensive review: antitumor necrosis factor agents in inflammatory bowel disease and factors implicated in treatment response. Therap Adv Gastroenterol 2013;6:269-93
  • Ben-Horin S, Chowers Y. Tailoring anti-TNF therapy in IBD: drug levels and disease activity. Nat Rev Gastroenterol Hepatol 2014;11:243-55
  • Li J, Yang C, Xia Y, et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 2001;98:3241-8
  • Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS J 2012;14:296-302
  • Cohen BA, Oger J, Gagnon A, et al. The implications of immunogenicity for protein-based multiple sclerosis therapies. J Neurol Sci 2008;275:7-17
  • Ragnhammar P, Friesen HJ, Frodin JE, et al. Induction of anti-recombinant human granulocyte-macrophage colony-stimulating factor (Escherichia coli-derived) antibodies and clinical effects in nonimmunocompromised patients. Blood 1994;84:4078-87
  • Van Haeften TW. Clinical significance of insulin antibodies in insulin-treated diabetic patients. Diabetes Care 1989;12:641-8
  • Walford S, Allison SP, Reeves WG. The effect of insulin antibodies on insulin dose and diabetic control. Diabetologia 1982;22:106-10
  • Tovey MG, Lallemand C. Immunogenicity and other problems associated with the use of biopharmaceuticals. Ther Adv Drug Saf 2011;2:113-28
  • Tamilvanan S, Raja NL, Sa B, et al. Clinical concerns of immunogenicity produced at cellular levels by biopharmaceuticals following their parenteral administration into human body. J Drug Target 2010;18:489-98
  • van Schouwenburg PA, Rispens T, Wolbink GJ. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol 2013;9:164-72
  • Chung CH, Mirakhur B, Chan E, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med 2008;358:1109-17
  • Harding FA, Stickler MM, Razo J, et al. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. MAbs 2010;2:256-65
  • Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006;8:E501-7
  • Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia “epidemic”–mystery completely revealed? Perit Dial Int 2007;27(Suppl 2):S303-7
  • Billiet T, Vande Casteele N, Van Stappen T, et al. Immunogenicity to infliximab is associated with HLA-DRB1. Gut 2015;63:1344-5
  • Ben-Horin S, Yavzori M, Katz L, et al. The immunogenic part of infliximab is the F(ab’)2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut 2011;60:41-8
  • Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford) 2011;50:1445-52
  • Garces 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 2013;72:1947-55
  • Maneiro JR, Salgado E, Gomez-Reino JJ. Immunogenicity of monoclonal antibodies against tumor necrosis factor used in chronic immune-mediated Inflammatory conditions: systematic review and meta-analysis. JAMA Intern Med 2013;173:1416-28
  • Hanauer SB, Wagner CL, Bala M, 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
  • Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med 2003;348:601-8
  • Vermeire S, Noman M, Van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn’s disease. Gut 2007;56:1226-31
  • Jung SM, Kim HS, Kim HR, et al. Immunogenicity of anti-tumour necrosis factor therapy in Korean patients with rheumatoid arthritis and ankylosing spondylitis. Int Immunopharmacol 2014;21:20-5
  • Plasencia C, Pascual-Salcedo D, Nuno L, et al. Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Ann Rheum Dis 2012;71:1955-60
  • Steenholdt C, Svenson M, Bendtzen K, et al. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2011;34:51-8
  • Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut 2015. [Epub ahead of print]
  • Brinks V. Immunogenicity of biosimilar monoclonal antibodies. Generics Biosimilars Initiat J 2013;2:188-93
  • Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Ann Rheum Dis 2013;72(Suppl 3):73 [OP0068]
  • Park W, Jaworski J, Brzezicki J, et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Ann Rheum Dis 2013;72(Suppl 3):516 [FRI0421]
  • Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013;65:3326 (L15)
  • Yoo D, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum 2013;65:3319 (L1)
  • Fiorino G, Danese S. The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol 2014;28:465-71
  • Cassinotti A, Travis S. Incidence and clinical significance of immunogenicity to infliximab in Crohn’s disease: a critical systematic review. Inflamm Bowel Dis 2009;15:1264-75
  • Jani M, Barton A, Warren RB, et al. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford) 2014;53:213-22
  • European Medicines Agency. Remicade (infliximab). Summary of Product Characteristics. 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf [Last accessed 19 July 2015]
  • Steenholdt C, Bendtzen K, Brynskov J, et al. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn’s disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol 2014;109:1055-64
  • Vande Casteele N, Khanna R, Levesque BG, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut 2014. [Epub ahead of print]
  • Ungar B, Anafy A, Yanai H, et al. Significance of low level infliximab in the absence of anti-infliximab antibodies. World J Gastroenterol 2015;21:1907-14
  • Ungar B, Chowers Y, Yavzori M, et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014;63:1258-64
  • Steenholdt C, Al-khalaf M, Brynskov J, et al. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis 2012;18:2209-17
  • Vande Casteele N, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol 2013;108:962-71
  • Feagan BG, McDonald JW, Panaccione R, et al. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn’s disease. Gastroenterology 2014;146:681-8 e1
  • St Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:1451-9
  • Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn’s Disease. Available from: https://clinicaltrials.gov/ct2/show/NCT02096861
  • The NOR-SWITCH Study. Available from: https://clinicaltrials.gov/ct2/show/NCT02148640
  • Baker MP, Reynolds HM, Lumicisi B, Bryson CJ. Immunogenicity of protein therapeutics: the key causes, consequences and challenges. Self Nonself 2010;1:314-22
  • Wirth M, Heidenreich A, Gschwend JE, et al. A multicenter phase 1 study of EMD 525797 (DI17E6), a novel humanized monoclonal antibody targeting αv integrins, in progressive castration-resistant prostate cancer with bone metastases after chemotherapy. Eur Urol 2014;65:897-904

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