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

被引：180

作者：

Casteele, N. Vande ^{[1
]}

Buurman, D. J. ^{[2
]}

Sturkenboom, M. G. G. ^{[3
]}

Kleibeuker, J. H. ^{[2
]}

Vermeire, S. ^{[4
]}

Rispens, T. ^{[5
]}

van der Kleij, D. ^{[6
]}

Gils, A. ^{[1
]}

Dijkstra, G. ^{[2
]}

机构：

[1] Katholieke Univ Leuven, Lab Pharmaceut Biol, B-3000 Louvain, Belgium

[2] Univ Groningen, Univ Med Ctr Groningen, Dept Gastroenterol & Hepatol, Groningen, Netherlands

[3] Univ Groningen, Univ Med Ctr Groningen, Dept Hosp & Clin Pharm, Groningen, Netherlands

[4] UZ Leuven, Div Gastroenterol, Louvain, Belgium

[5] Univ Amsterdam, Acad Med Ctr, Dept Immunopathol, Sanquin Res & Landsteiner Lab, NL-1105 AZ Amsterdam, Netherlands

[6] Sanquin Diagnost, Lab Monoclonal Therapeut, Amsterdam, Netherlands

来源：

ALIMENTARY PHARMACOLOGY & THERAPEUTICS | 2012年 / 36卷 / 08期

关键词：

CROHNS-DISEASE; MONOCLONAL-ANTIBODY; ULCERATIVE-COLITIS; RHEUMATOID-ARTHRITIS; CLINICAL-RESPONSE; ADALIMUMAB; IMMUNOGENICITY; INDUCTION; TRIAL; TERM;

D O I：

10.1111/apt.12030

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：765 / 771

页数：7

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