Comparison of Techniques for Monitoring Infliximab and Antibodies Against Infliximab in Crohn's Disease

Steenholdt, Casper; Ainsworth, Mark; Tovey, Michaël G.; Klausen, Tobias W.; Thomsen, Ole Østergaard; Brynskov, Jørn; Bendtzen, Klaus

doi:10.1097/ftd.0b013e31828d23c3

Cited by 105 publications

(91 citation statements)

References 30 publications

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“…Both techniques, despite the presumable superior analytical accuracy, did not demonstrate superior diagnostic value on direct comparison with ELISA techniques [34,40].…”

Section: Evaluation Of Serum Levels and Atismentioning

confidence: 85%

Therapeutic Drug Monitoring in Inflammatory Bowel Disease

2017

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Tumor necrosis factor (TNF)-α inhibitors and thiopurines are among the most important classes of medications utilized in the clinical management of Crohn's disease and ulcerative colitis. A signifi cant proportion of patients loses response to these agents or develops adverse eff ects during the course of the treatment. Monitoring of drug levels and anti-drug antibodies (for TNF-α inhibitors) and metabolite levels (for thiopurines) can provide valuable insight into the possible etiology of unfavorable outcomes and allow for an appropriate management strategy for these patients. Th is review summarizes the current knowledge on the clinical implications of therapeutic drug monitoring in infl ammatory bowel disease patients treated with TNF-α inhibitors and thiopurines.

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“…Both techniques, despite the presumable superior analytical accuracy, did not demonstrate superior diagnostic value on direct comparison with ELISA techniques [34,40].…”

Section: Evaluation Of Serum Levels and Atismentioning

confidence: 85%

Therapeutic Drug Monitoring in Inflammatory Bowel Disease

2017

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“…Significant discrepancies have been shown when measuring ADA formation with different assays which could lead to biased clinical outcome interpretation and treatments strategies [111,142,143] and could be caused by differences in assay performance as well as sampling strategies. As discussed above, each assay has its own advantages and limitations with factors such as sensitivity, specificity, drug interference and antibody isotypes, specifics of the sampled population, dosing and sampling time frames all contributing to discrepancies.…”

Section: Outstanding Questions and Call For Helpmentioning

confidence: 97%

Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products

Yin

Chen

Vicini

et al. 2015

Cellular Immunology

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“…Several methodologies are currently available for measuring serum TNF antagonist drug concentrations and for detecting ADAs, which show significant variations in both analytical sensitivity and specificity (45)(46)(47)(48). 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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Comparison of Techniques for Monitoring Infliximab and Antibodies Against Infliximab in Crohn's Disease

Cited by 105 publications

References 30 publications

Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products

Immunogenicity Assessment of Tumor Necrosis Factor Antagonists in the Clinical Laboratory

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