Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)

Expert Review of Clinical Immunology

Volumn 11, Issue , 2015, Pages S33-S41

  Kim, Ji Soo ^a   Kim, Sung Hwan ^a   Kwon, ByoungOh ^a   Hong, SeungSuh ^a  

^a Celltrion Inc   (South Korea)

Author keywords

analytic methods; anti drug antibodies; biosimilar; CT P13; electrochemiluminescent assay; ELISA; homogeneous mobility shift assay; immunoassays; infliximab; radioimmunoassay

Indexed keywords

BIOSIMILAR AGENT; CTP 13; INFLIXIMAB; UNCLASSIFIED DRUG; ANTIBODY; CT-P13; MONOCLONAL ANTIBODY;

COMPARATIVE STUDY; DRUG BLOOD LEVEL; DRUG COMPETITION; DRUG TOLERANCE; ELECTROCHEMILUMINESCENT IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; HOMOGENEOUS MOBILITY SHIFT ASSAY; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; RADIOIMMUNOASSAY; REVIEW; GEL MOBILITY SHIFT ASSAY; IMMUNOLOGY; PROCEDURES; REPRODUCIBILITY;

ANTIBODIES; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; ELECTROPHORETIC MOBILITY SHIFT ASSAY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY; INFLIXIMAB; RADIOIMMUNOASSAY; REPRODUCIBILITY OF RESULTS;

EID: 84942257038     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2015.1090312     Document Type: Review

References (41)

1. Emi Aikawa N, de Carvalho JF, Artur Almeida Silva C, et al. Immunogenicity of anti-TNF-alpha agents in autoimmune diseases. Clin Rev Allergy Immunol 2010;38:82-9
2. Brennan FR, Morton LD, Spindeldreher S, et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. MAbs 2010;2:233-55
3. US Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2015. Available from: www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf [Last accessed 25 June 2015]
4. European Medicines Agency. Guideline on similar biological medicinal products. 2014. Available from: www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/10/WC500176768.pdf [Last accessed 21 July 2015]
5. Shankar G, Shores E, Wagner C, et al. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol 2006;24:274-80
6. Liang M, Klakamp SL, Funelas C, et al. Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev Technol 2007;5: 655-62
7. Shankar G, Arkin S, Cocea L, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J 2014;16: 658-73
8. Mikulskis A, Yeung D, Subramanyam M, et al. Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development. J Immunol Methods 2011;365:38-49
9. World Health Organization. Expert committee on biological standardization. geneva, 19 to 23 October 2009. 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]
10. Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-17
11. 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 28 July 2015]
12. 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
13. 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
14. Bloem K, van Leeuwen A, Verbeek G, et al. Systematic comparison of drug-tolerant assays for anti-drug antibodies in a cohort of adalimumab-treated rheumatoid arthritis patients. J Immunol Methods 2015;418: 29-38
15. Hernandez-Florez D, Valor L, de la Torre I, et al. Comparison of two ELISA versions for infliximab serum levels in patients diagnosed with ankylosing spondylitis. Rheumatol Int 2015;35:1021-5
16. 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
17. Wang SL, Ohrmund L, Hauenstein S, et al. Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods 2012;382: 177-88
18. Xiao Y, Halford A, Hayes R. Bioanalytical method development and validation of biosimilars: lessons learned. MOJ Immunol 2014;1:00004
19. 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
20. Degn SE, Andersen SH, Jensen L, et al. Assay interference caused by antibodies reacting with rat kappa light-chain in human sera. J Immunol Methods 2011;372: 204-8
21. 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
22. Ben-Horin S, Mazor Y, Yanai H, et al. The decline of anti-drug antibody titres after discontinuation of anti-TNFs: implications for predicting re-induction outcome in IBD. Aliment Pharmacol Ther 2012;35:714-22
23. Aarden L, Ruuls SR, Wolbink G. Immunogenicity of anti-tumor necrosis factor antibodies-toward improved methods of anti-antibody measurement. Curr Opin Immunol 2008;20:431-5
24. Bendtzen K, Geborek P, Svenson M, et al. 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
25. Wolbink GJ, Vis M, Lems W, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006;54:711-15
26. Shankar G, Devanarayan V, Amaravadi L, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 2008;48:1267-81
27. Ducourau E, Mulleman D, Paintaud G, et al. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther 2011;13:R105
28. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41:1552-63
29. 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
30. Rahman MU, Strusberg I, Geusens P, et al. Double-blinded infliximab dose escalation in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66:1233-8
31. St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50: 3432-43
32. Vultaggio A, Matucci A, Nencini F, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy 2010;65: 657-61
33. Kosmac M, Avcin T, Toplak N, et al. Exploring the binding sites of anti-infliximab antibodies in pediatric patients with rheumatic diseases treated with infliximab. Pediatr Res 2011;69:243-8
34. Ruperto N, Lovell DJ, Cuttica R, et al. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension. Ann Rheum Dis 2010;69:718-22
35. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999;354:1932-9
36. Vande Casteele N, Buurman DJ, Sturkenboom MG, et al. Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays. Aliment Pharmacol Ther 2012;36: 765-71
37. Braun J, Deodhar A, Dijkmans B, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum 2008;59:1270-8
38. Xu Z, Seitz K, Fasanmade A, et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol 2008;48:681-95
39. 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]
40. European Medicines Agency. Remicade (infliximab). summary of product characteristics. 2009. Available from: www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000240/WC500050888.pdf [Last accessed 28 July 2015]
41. Ruperto N, Lovell DJ, Cuttica R, et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum 2007;56:3096-106