Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars

Annals of the Rheumatic Diseases

Volumn 75, Issue 9, 2016, Pages 1693-1696

  Ruiz Argüello, M Begoña ^a   Maguregui, Ainara ^a   Ruiz Del Agua, Ainhoa ^a   Pascual Salcedo, Dora ^b   Martínez Feito, Ana ^c   Jurado, Teresa ^b   Plasencia, Chamaida ^b   Balsa, Alejandro ^b   Llinares Tello, Francisca ^d   Rosas, José ^d   Torres, Nerea ^a   Martínez, Antonio ^a   Nagore, Daniel ^a  

^a Progenika Biopharma A Grifols Company   (Spain)

^b HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^c HOSPITAL UNIVERSITARIO LA PAZ IDIPAZ   (Spain)

^d HOSPITAL MARINA BAIXA   (Spain)

Author keywords

Anti TNF; Rheumatoid Arthritis; Spondyloarthritis; Treatment

Indexed keywords

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

ADULT; ANTIBODY DETECTION; ARTICLE; CONTROLLED STUDY; DRUG CROSS REACTIVITY; DRUG DETERMINATION; DRUG EFFECT; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SPONDYLARTHRITIS; AGED; BLOOD; CASE CONTROL STUDY; CROSS REACTION; DOSE RESPONSE; DRUG MONITORING; DRUG SUBSTITUTION; IMMUNOLOGY; MIDDLE AGED; RETROSPECTIVE STUDY; RHEUMATIC DISEASES; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; BIOSIMILAR PHARMACEUTICALS; CASE-CONTROL STUDIES; CROSS REACTIONS; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; DRUG MONITORING; DRUG SUBSTITUTION; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RHEUMATIC DISEASES; YOUNG ADULT;

EID: 84961838400     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2015-208684     Document Type: Article

References (15)

1. McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs 2014;28:313-21.
2. Braun J, Kudrin A. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases. Immunotherapy 2015;7:73-87.
3. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Assessment report: Inflectra (infliximab). 2013. http://www.ema.europa.eu (accessed Aug 2015).
4. 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.
5. 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.
6. 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; Published Online First: 20 Apr 2015. doi:10.1136/gutjnl- 2015-309290.
7. 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.
8. Hart MH, de Vrieze H, Wouters D, et al. Differential effect of drug interference in immunogenicity assays. J Immunol Methods 2011;372:196-203.
9. 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.
10. Bandrés Ciga S, Salvatierra J, Lóopez-Sidro M, et al. An examination of the mechanisms involved in secondary clinical failure to adalimumab or etanercept in inflammatory arthropathies. J Clin Rheumatol 2015;21:115-19.
11. Chen DY, Chen YM, Tsai WC, et al. Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis. Ann Rheum Dis 2015;74:e16.
12. Rosas J, Llinares-Tello F, de la Torre I, et al. Clinical relevance of monitoring serum levels of adalimumab in patients with rheumatoid arthritis in daily practice. Clin Exp Rheumatol 2014;32:942-8.
13. Steenholdt C, Brynskov J, Bendtzen K. Letter: persistence of anti-infliximab antibodies after discontinuation of infliximab in patients with IBD. Aliment Pharmacol Ther 2012;36:499-500; author reply 501.
14. van Schie KA, Hart MH, de Groot ER, et al. The antibody response against human and chimeric anti-TNF therapeutic antibodies primarily targets the TNF binding region. Ann Rheum Dis 2015;74:311-14.
15. van Schouwenburg PA, van de Stadt LA, de Jong RN, et al. Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Ann Rheum Dis 2013;72:104-9.