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Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays

Background Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measur... Full description

Journal Title: Alimentary pharmacology & therapeutics 2012-10, Vol.36 (8), p.765-771
Main Author: Vande Casteele, N.
Other Authors: Buurman, D. J. , Sturkenboom, M. G. G. , Kleibeuker, J. H. , Vermeire, S. , Rispens, T. , van der Kleij, D. , Gils, A. , Dijkstra, G.
Format: Electronic Article Electronic Article
Language: English
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Publisher: Oxford: Blackwell Publishing Ltd
ID: ISSN: 0269-2813
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recordid: cdi_proquest_miscellaneous_1041142018
title: Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
format: Article
creator:
  • Vande Casteele, N.
  • Buurman, D. J.
  • Sturkenboom, M. G. G.
  • Kleibeuker, J. H.
  • Vermeire, S.
  • Rispens, T.
  • van der Kleij, D.
  • Gils, A.
  • Dijkstra, G.
subjects:
  • Anti-Inflammatory Agents, Non-Steroidal - blood
  • Anti-Inflammatory Agents, Non-Steroidal - immunology
  • Antibodies - blood
  • Antibodies, Monoclonal - blood
  • Antibodies, Monoclonal - immunology
  • Antigen-Antibody Reactions
  • Biological and medical sciences
  • Biomarkers - blood
  • Digestive system
  • False Positive Reactions
  • Gastroenterology. Liver. Pancreas. Abdomen
  • Humans
  • Immunoassay - methods
  • Infliximab
  • Medical sciences
  • musculoskeletal diseases
  • Pharmacology. Drug treatments
  • Reagent Kits, Diagnostic - standards
  • Statistics as Topic
  • UMCG Approved
ispartof: Alimentary pharmacology & therapeutics, 2012-10, Vol.36 (8), p.765-771
description: Background Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measuring infliximab and ATI. Methods Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands. Results All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C. Conclusions There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples
language: eng
source:
identifier: ISSN: 0269-2813
fulltext: no_fulltext
issn:
  • 0269-2813
  • 1365-2036
url: Link


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titleDetection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
creatorVande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.
creatorcontribVande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.
descriptionBackground Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measuring infliximab and ATI. Methods Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands. Results All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C. Conclusions There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples
editionAliment Pharmacol Ther 2012; 36: 765-771
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subjectAnti-Inflammatory Agents, Non-Steroidal - blood ; Anti-Inflammatory Agents, Non-Steroidal - immunology ; Antibodies - blood ; Antibodies, Monoclonal - blood ; Antibodies, Monoclonal - immunology ; Antigen-Antibody Reactions ; Biological and medical sciences ; Biomarkers - blood ; Digestive system ; False Positive Reactions ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Immunoassay - methods ; Infliximab ; Medical sciences ; musculoskeletal diseases ; Pharmacology. Drug treatments ; Reagent Kits, Diagnostic - standards ; Statistics as Topic ; UMCG Approved
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3Kleibeuker, J. H.
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5Rispens, T.
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0Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
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descriptionBackground Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measuring infliximab and ATI. Methods Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands. Results All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C. Conclusions There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples
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1Anti-Inflammatory Agents, Non-Steroidal - immunology
2Antibodies - blood
3Antibodies, Monoclonal - blood
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8Digestive system
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13Infliximab
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16Pharmacology. Drug treatments
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18Statistics as Topic
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titleDetection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
authorVande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.
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0Anti-Inflammatory Agents, Non-Steroidal - blood
1Anti-Inflammatory Agents, Non-Steroidal - immunology
2Antibodies - blood
3Antibodies, Monoclonal - blood
4Antibodies, Monoclonal - immunology
5Antigen-Antibody Reactions
6Biological and medical sciences
7Biomarkers - blood
8Digestive system
9False Positive Reactions
10Gastroenterology. Liver. Pancreas. Abdomen
11Humans
12Immunoassay - methods
13Infliximab
14Medical sciences
15musculoskeletal diseases
16Pharmacology. Drug treatments
17Reagent Kits, Diagnostic - standards
18Statistics as Topic
19UMCG Approved
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atitleDetection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
jtitleAlimentary pharmacology & therapeutics
addtitleAliment Pharmacol Ther
date2012-10
risdate2012
volume36
issue8
spage765
epage771
pages765-771
issn0269-2813
eissn1365-2036
notesFund for Scientific Research-Flanders - No. G.0617.12
abstractBackground Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti-drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays for measuring infliximab and ATI. Methods Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands. Results All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C. Conclusions There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples
copOxford
pubBlackwell Publishing Ltd
pmid22928581
doi10.1111/apt.12030
tpages7
editionAliment Pharmacol Ther 2012; 36: 765-771