Development of an ELISA-Based Competitive Binding Assay for the Analysis of Drug Concentration and Antidrug Antibody Levels in Patients Receiving Adalimumab or Infliximab

Hock, Barry D.; Stamp, Lisa K.; Hayman, Matthew; Keating, Paula; Helms, Esther T. Johanna; Barclay, Murray L.

doi:10.1097/ftd.0000000000000229

Cited by 28 publications

(16 citation statements)

References 31 publications

(73 reference statements)

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“…However, these assays often require specialised laboratories and do not necessarily provide information on ability of detected anti‐drug antibody to modify aspects of the drug–TNF interaction. Therefore, a competitive ligand‐binding assay can be useful not only because it uses simple equipment, but also because it can give an accurate measure of neutralising antibodies . On the other hand, HMSA is a drug‐concentration tolerant assay that allows anti‐drug antibody detection regardless of the drug concentration in the sample.…”

Section: Discussionmentioning

confidence: 99%

“…Concentrations of adalimumab and infliximab were measured by ELISA. Levels of neutralising anti‐drug antibodies were determined using a competitive ligand‐binding ELISA . The levels of total anti‐drug antibodies were determined using a drug‐tolerant HMSA .…”

Section: Methodsmentioning

confidence: 99%

“…ELISA assays are the most commonly used. The strengths and weaknesses of the different assays have been well described . When trough drug concentrations have been correlated with disease activity in previous studies, the minimum trough concentrations associated with positive outcomes have varied between 3 and 10 mg/L .…”

Section: Introductionmentioning

confidence: 99%

“…Variation in assay methodology may account in part for the variation in minimum trough concentrations associated with disease control. In New Zealand, a competitive binding ELISA assay has been developed for both infliximab and adalimumab anti‐drug antibodies, that addressed problems with previous assays, including lack of sensitivity and specificity . HMSA has also been developed locally, which, when used alongside the ELISA, distinguishes neutralising from non‐neutralising antibodies and enables anti‐drug antibody detection regardless of the drug concentration in the sample .…”

Section: Introductionmentioning

confidence: 99%

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Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Barclay

Karim

Helms

et al. 2019

Internal Medicine Journal

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Barclay

Karim

Helms

et al. 2019

Internal Medicine Journal

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“…Most of these are primarily binding-based assays, including solid-phase ELISA methods (8,45,49 ) and liquidphase, HPLC-based homogenous mobility shift assay (HMSA) (50 ); in addition, a functional cell-based reporter gene assay (RGA) has been developed (51 ) and is currently available for clinical use (52 ).…”

Section: Methods For Measuring Serum Drug Concentrations and Adasmentioning

confidence: 99%

Immunogenicity Assessment of Tumor Necrosis Factor Antagonists in the Clinical Laboratory

Lázár‐Molnár

Delgado

2016

Clinical Chemistry

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BACKGROUND Tumor necrosis factor (TNF) antagonists are increasingly used for the treatment of inflammatory and autoimmune diseases. Immunogenicity of these drugs poses therapeutic challenges such as therapeutic failure and adverse effects in a number of patients. Evaluation of clinical nonresponsiveness includes laboratory testing for drug concentrations and detecting the presence of antidrug antibodies. CONTENT This review provides an overview of the immunogenicity of TNF antagonists and testing methodologies currently available for measuring antidrug antibody response, which decreases treatment efficacy and may result in therapeutic failure. This review summarizes methodologies such as binding assays, including ELISA and HPLC-based homogenous mobility shift assay, as well as functional cell-based assays such as reporter gene assay. Furthermore, based on the laboratory findings of testing for antidrug antibody response, as well as serum drug concentrations, an algorithm is provided for interpretation, based on the current available literature and guidelines, which may aid in determining optimal therapy after treatment failure. SUMMARY Laboratory testing methodologies for measuring serum concentrations of TNF inhibitors and antidrug antibodies are clinically available. These methods provide an evidence-based, personalized approach for the workup of patients showing treatment failure, which saves time and resources, and contributes to improved patient care.

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Approaches for the detection and analysis of antidrug antibodies to biopharmaceuticals: A review

Suh

Kyei

Hage

2022

J of Separation Science

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Antibody-based therapeutic agents and other biopharmaceuticals are now used in the treatment of many diseases. However, when these biopharmaceuticals are administrated to patients, an immune reaction may occur that can reduce the drug's efficacy and lead to adverse side-effects. The immunogenicity of biopharmaceuticals can be evaluated by detecting and measuring antibodies that have been produced against these drugs, or antidrug antibodies. Methods for antidrug antibody detection and analysis can be important during the selection of a therapeutic approach based on such drugs and is crucial when developing and testing new biopharmaceuticals. This review examines approaches that have been used for antidrug antibody detection, measurement, and characterization. Many of these approaches are based on immunoassays and antigen binding tests, including homogeneous mobility shift assays. Other techniques that have been used for the analysis of antidrug antibodies are capillary electrophoresis, reporter gene assays, surface plasmon resonance spectroscopy, and liquid chromatographymass spectrometry. The general principles of each approach will be discussed, along with their recent applications with regards to antidrug antibody analysis.

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Development of an ELISA-Based Competitive Binding Assay for the Analysis of Drug Concentration and Antidrug Antibody Levels in Patients Receiving Adalimumab or Infliximab

Cited by 28 publications

References 31 publications

Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Immunogenicity Assessment of Tumor Necrosis Factor Antagonists in the Clinical Laboratory

Approaches for the detection and analysis of antidrug antibodies to biopharmaceuticals: A review

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