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Volumn 22, Issue 4, 2016, Pages 969-975

Harmonization of infliximab and anti-infliximab assays facilitates the comparison between originators and biosimilars in clinical samples

Author keywords

anti drug antibody; biosimilar pharmaceuticals; CT P13; infliximab; therapeutic drug monitoring

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BIOSIMILAR AGENT; CORTICOSTEROID; DRUG ANTIBODY; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; GASTROINTESTINAL AGENT;

EID: 84962299660     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/MIB.0000000000000709     Document Type: Article
Times cited : (44)

References (32)
  • 1
    • 0037018761 scopus 로고    scopus 로고
    • Maintenance infliximab for Crohns disease: The ACCENT i randomised trial
    • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohns disease: the ACCENT I randomised trial. Lancet. 2002;359: 1541-1549.
    • (2002) Lancet. , vol.359 , pp. 1541-1549
    • Hanauer, S.B.1    Feagan, B.G.2    Lichtenstein, G.R.3
  • 2
    • 28844473957 scopus 로고    scopus 로고
    • Infliximab for induction and maintenance therapy for ulcerative colitis
    • Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353: 2462-2476.
    • (2005) N Engl J Med. , vol.353 , pp. 2462-2476
    • Rutgeerts, P.1    Sandborn, W.J.2    Feagan, B.G.3
  • 3
    • 0031660364 scopus 로고    scopus 로고
    • Therapeutic efficacy of multiple intravenous infusions of anti-Tumor necrosis factor alpha monoclonal antibody combined with low-Dose weekly methotrexate in rheumatoid arthritis
    • 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;41:1552-1563.
    • (1998) Arthritis Rheum. , vol.41 , pp. 1552-1563
    • Maini, R.N.1    Breedveld, F.C.2    Kalden, J.R.3
  • 4
    • 21244449214 scopus 로고    scopus 로고
    • Persistent clinical response to the anti-TNF-Alpha antibody infliximab in patients with ankylosing spondylitis over 3 years
    • Braun J, Baraliakos X, Brandt J, et al. Persistent clinical response to the anti-TNF-Alpha antibody infliximab in patients with ankylosing spondylitis over 3 years. Rheumatology. 2005;44:670-676.
    • (2005) Rheumatology. , vol.44 , pp. 670-676
    • Braun, J.1    Baraliakos, X.2    Brandt, J.3
  • 5
    • 26644433889 scopus 로고    scopus 로고
    • Infliximab induction and maintenance therapy for moderate-To-severe psoriasis: A phase III, multicentre, doubleblind trial
    • Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-To-severe psoriasis: a phase III, multicentre, doubleblind trial. Lancet. 2005;366:1367-1374.
    • (2005) Lancet. , vol.366 , pp. 1367-1374
    • Reich, K.1    Nestle, F.O.2    Papp, K.3
  • 6
    • 58149132609 scopus 로고    scopus 로고
    • Infliximab pharmacokinetics in inflammatory bowel disease patients
    • Ternant D, Aubourg A, Magdelaine-Beuzelin C, et al. Infliximab pharmacokinetics in inflammatory bowel disease patients. Ther Drug Monit. 2008;30:523-529.
    • (2008) Ther Drug Monit. , vol.30 , pp. 523-529
    • Ternant, D.1    Aubourg, A.2    Magdelaine-Beuzelin, C.3
  • 7
    • 84925759693 scopus 로고    scopus 로고
    • Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: A population pharmacokinetic study
    • Dotan I, Ron Y, Yanai H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel Dis. 2014;20: 2247-2259.
    • (2014) Inflamm Bowel Dis. , vol.20 , pp. 2247-2259
    • Dotan, I.1    Ron, Y.2    Yanai, H.3
  • 8
    • 84892979466 scopus 로고    scopus 로고
    • Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: A retrospective analysis of the ACCENT i trial
    • Cornillie F, Hanauer SB, Diamond RH, et al. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut. 2014;63:1721-1727.
    • (2014) Gut. , vol.63 , pp. 1721-1727
    • Cornillie, F.1    Hanauer, S.B.2    Diamond, R.H.3
  • 9
    • 84913534923 scopus 로고    scopus 로고
    • Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis
    • e1295
    • Adedokun OJ, Sandborn WJ, Feagan BG, et al. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology. 2014;147:1296-1307.e1295.
    • (2014) Gastroenterology. , vol.147 , pp. 1296-1307
    • Adedokun, O.J.1    Sandborn, W.J.2    Feagan, B.G.3
  • 10
    • 84925320962 scopus 로고    scopus 로고
    • A panel to predict longterm outcome of infliximab therapy for patients with ulcerative colitis
    • Arias MT, Vande Casteele N, Vermeire S, et al. A panel to predict longterm outcome of infliximab therapy for patients with ulcerative colitis. Clin Gastroenterol Hepatol. 2015;13:531-538.
    • (2015) Clin Gastroenterol Hepatol. , vol.13 , pp. 531-538
    • Arias, M.T.1    Vande Casteele, N.2    Vermeire, S.3
  • 11
    • 84894640694 scopus 로고    scopus 로고
    • Therapeutic drug monitoring in inflammatory bowel disease: Current state and future perspectives
    • Vande Casteele N, Feagan BG, Gils A, et al. Therapeutic drug monitoring in inflammatory bowel disease: current state and future perspectives. Curr Gastroenterol Rep. 2014;16:378.
    • (2014) Curr Gastroenterol Rep. , vol.16 , pp. 378
    • Vande Casteele, N.1    Feagan, B.G.2    Gils, A.3
  • 12
    • 84930015437 scopus 로고    scopus 로고
    • Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease
    • Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148:1320-1329.
    • (2015) Gastroenterology. , vol.148 , pp. 1320-1329
    • Vande Casteele, N.1    Ferrante, M.2    Van Assche, G.3
  • 13
    • 79953788656 scopus 로고    scopus 로고
    • Assessing response and loss of response to biological therapies in IBD
    • Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol. 2011;106:685-698.
    • (2011) Am J Gastroenterol. , vol.106 , pp. 685-698
    • Yanai, H.1    Hanauer, S.B.2
  • 14
    • 77957309991 scopus 로고    scopus 로고
    • Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: Definitions, frequency and pharmacological aspects
    • 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;4:355-366.
    • (2010) J Crohns Colitis. , vol.4 , pp. 355-366
    • Allez, M.1    Karmiris, K.2    Louis, E.3
  • 15
    • 84872050633 scopus 로고    scopus 로고
    • Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): A meta-Analysis
    • Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-Analysis. Am J Gastroenterol. 2013;108: 40-47.
    • (2013) Am J Gastroenterol. , vol.108 , pp. 40-47
    • Nanda, K.S.1    Cheifetz, A.S.2    Moss, A.C.3
  • 16
    • 0037434552 scopus 로고    scopus 로고
    • Influence of immunogenicity on the long-Term efficacy of infliximab in Crohns disease
    • Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-Term efficacy of infliximab in Crohns disease. N Engl J Med. 2003; 348:601-608.
    • (2003) N Engl J Med. , vol.348 , pp. 601-608
    • Baert, F.1    Noman, M.2    Vermeire, S.3
  • 17
    • 84937978647 scopus 로고    scopus 로고
    • Generation of a highly specific monoclonal anti-infliximab antibody for harmonization of TNF-coated infliximab assays
    • Van Stappen T, Brouwers E, Tops S, et al. Generation of a highly specific monoclonal anti-infliximab antibody for harmonization of TNF-coated infliximab assays. Ther Drug Monit. 2015;37:479-485.
    • (2015) Ther Drug Monit. , vol.37 , pp. 479-485
    • Van Stappen, T.1    Brouwers, E.2    Tops, S.3
  • 18
    • 84940942570 scopus 로고    scopus 로고
    • An optimized antiinfliximab bridging enzyme-linked immunosorbent assay for harmonization of anti-infliximab antibody titers in patients with inflammatory bowel diseases
    • Van Stappen T, Billiet T, Vande Casteele N, et al. An optimized antiinfliximab bridging enzyme-linked immunosorbent assay for harmonization of anti-infliximab antibody titers in patients with inflammatory bowel diseases. Inflamm Bowel Dis. 2015;21:2172-2177.
    • (2015) Inflamm Bowel Dis. , vol.21 , pp. 2172-2177
    • Van Stappen, T.1    Billiet, T.2    Vande Casteele, N.3
  • 19
    • 84878624235 scopus 로고    scopus 로고
    • ECCO GBaOBo ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
    • Danese S, Gomollon F; ECCO GBaOBo. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7:586-589.
    • (2013) J Crohns Colitis. , vol.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 20
    • 84894232162 scopus 로고    scopus 로고
    • EMA response to ECCO position statement on biosimilars
    • Danese S, Gomollon F, Michetti P. EMA response to ECCO position statement on biosimilars. J Crohns Colitis. 2014;8:259.
    • (2014) J Crohns Colitis. , vol.8 , pp. 259
    • Danese, S.1    Gomollon, F.2    Michetti, P.3
  • 21
    • 0008348082 scopus 로고    scopus 로고
    • European Medicines Agency: Remsima. Available at: Accessed July 23
    • European Medicines Agency: Remsima. European Public Assessment Report. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-Assessment-report/human/002576/WC500151486. pdf. Accessed July 23, 2015.
    • (2015) European Public Assessment Report
  • 22
    • 0008348082 scopus 로고    scopus 로고
    • I European Medicines Agency: Inflectra. Available at: Accessed July 23
    • I European Medicines Agency: Inflectra. European Public Assessment Report. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Summary-for-The-public/human/002778/WC500151491. pdf. Accessed July 23, 2015.
    • (2015) European Public Assessment Report
  • 23
    • 84872175228 scopus 로고    scopus 로고
    • Biosimilar monoclonal antibodies: A science-based regulatory challenge
    • Declerck PJ. Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert Opin Biol Ther. 2013;13:153-156.
    • (2013) Expert Opin Biol Ther. , vol.13 , pp. 153-156
    • Declerck, P.J.1
  • 24
    • 84883746909 scopus 로고    scopus 로고
    • 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
    • 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;72:1605-1612.
    • (2013) Ann Rheum Dis. , vol.72 , pp. 1605-1612
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 25
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallelgroup 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
    • Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallelgroup 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;72:1613-1620.
    • (2013) Ann Rheum Dis. , vol.72 , pp. 1613-1620
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3
  • 26
    • 44049096982 scopus 로고    scopus 로고
    • Population pharmacokinetics of infliximab in patients with ankylosing spondylitis
    • Xu Z, Seitz K, Fasanmade A, et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol. 2008; 48:681-695.
    • (2008) J Clin Pharmacol. , vol.48 , pp. 681-695
    • Xu, Z.1    Seitz, K.2    Fasanmade, A.3
  • 27
    • 71249099165 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis
    • Fasanmade AA, Adedokun OJ, Ford J, et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol. 2009;65:1211-1228.
    • (2009) Eur J Clin Pharmacol. , vol.65 , pp. 1211-1228
    • Fasanmade, A.A.1    Adedokun, O.J.2    Ford, J.3
  • 28
    • 79960283949 scopus 로고    scopus 로고
    • Pharmacokinetic properties of infliximab in children and adults with Crohns disease: A retrospective analysis of data from 2 phase III clinical trials
    • Fasanmade AA, Adedokun OJ, Blank M, et al. Pharmacokinetic properties of infliximab in children and adults with Crohns disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011;33: 946-964.
    • (2011) Clin Ther. , vol.33 , pp. 946-964
    • Fasanmade, A.A.1    Adedokun, O.J.2    Blank, M.3
  • 29
    • 84934294253 scopus 로고    scopus 로고
    • Clinical experience of the use of CTP13, a biosimilar to infliximab in patients with inflammatory bowel disease: A case series
    • Kang YS, Moon HH, Lee SE, et al. Clinical experience of the use of CTP13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci. 2015;60:951-956.
    • (2015) Dig Dis Sci. , vol.60 , pp. 951-956
    • Kang, Y.S.1    Moon, H.H.2    Lee, S.E.3
  • 30
    • 84940081554 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study
    • Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705-1712.
    • (2015) J Gastroenterol Hepatol. , vol.30 , pp. 1705-1712
    • Jung, Y.S.1    Park, D.I.2    Kim, Y.H.3
  • 31
    • 84939563221 scopus 로고    scopus 로고
    • Individualized therapy is a longterm cost-Effective method compared to dose intensification in Crohns disease patients failing infliximab
    • Steenholdt C, Brynskov J, Thomsen O, et al. Individualized therapy is a longterm cost-Effective method compared to dose intensification in Crohns disease patients failing infliximab. Dig Dis Sci. 2015;60:2762-2770.
    • (2015) Dig Dis Sci. , vol.60 , pp. 2762-2770
    • Steenholdt, C.1    Brynskov, J.2    Thomsen, O.3
  • 32
    • 84973896889 scopus 로고    scopus 로고
    • Cross-immunogenicity: Antibodies to infliximab in remicade-Treated patients with IBD similarly recognise the biosimilar remsima
    • [published online ahead of print April 20, doi: 10.1136/gutjnl-2015-309290
    • 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. [published online ahead of print April 20, 2015]. doi: 10.1136/gutjnl-2015-309290.
    • (2015) Gut
    • Ben-Horin, S.1    Yavzori, M.2    Benhar, I.3


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