Comparison of three commercially available ELISA assays for anti-infliximab antibodies

West, T.; Sam, Melissa; Toong, Catherine

doi:10.1016/j.pathol.2020.08.020

Cited by 7 publications

(3 citation statements)

References 20 publications

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“…Among them, ELISA-based kits are the most widely used in clinical laboratories. The ELISA tests used in this work have shown excellent correlation with other commercially available assays used for drug monitoring [ 32 , 33 ]. Likewise, no differences have been observed in the determination of the original infliximab or the biosimilar, nor in its interpretation [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study

Huguet

García-Lorenzo

Martí³

et al. 2022

Biomedicines

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Background: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment of patients with IBD. Methods: Multicenter, prospective study of patients with IBD in clinical remission, who had their treatment changed from intravenous (IV) infliximab to SC. Two groups of patients were evaluated according to whether they were on IV infliximab treatment at standard or intensified doses before the switch. Results: A total of 30 patients were on standard dosing and another 30 in intensified therapy. Treatment persistence in both groups at 6 months was greater than 95%. In both groups after the change, neither the biomarkers of inflammation nor the activity indices underwent significant changes at 3 and 6 months compared to the baseline value. Similarly, in both groups, infliximab trough levels showed a significant increase 3 and 6 months after the change to SC. No serious adverse events were registered. Conclusions: The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing.

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Section: Discussionmentioning

confidence: 99%

Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study

Huguet

García-Lorenzo

Martí³

et al. 2022

Biomedicines

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“…Infliximab concentration can be determined using commercially available ELISA kits or analyzers. 145,146 Advances in proteomics research have demonstrated that liquid chromatography-tandem mass spectrometry methods are also capable of analyzing peptides and proteins in biological matrices with high selectivity and specificity. 143,147,148 The lower limit of quantification varies between assays but is generally well below the therapeutic threshold, making it suitable for TDM applications, with reported LLOQs ranging from 0.001 to 0.06 mg/L.…”

Section: Quantification Of Infliximabmentioning

confidence: 99%

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Alsoud,

Moes,

Wang

et al. 2024

Therapeutic Drug Monitoring

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Background: Infliximab, an anti–tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on therapeutic drug monitoring (TDM) of infliximab in patients with IMIDs. It provides a practical guide on implementing TDM in current clinical practices and outlines priority areas for future research. Methods: The endorsing TDM of Biologics and Pharmacometrics Committees of the International Association of TDM and Clinical Toxicology collaborated to create this position statement. Results: Accumulating data support the evidence for TDM of infliximab in the treatment of inflammatory bowel diseases, with limited investigation in other IMIDs. A universal approach to TDM may not fully realize the benefits of improving therapeutic outcomes. Patients at risk for increased infliximab clearance, particularly with a proactive strategy, stand to gain the most from TDM. Personalized exposure targets based on therapeutic goals, patient phenotype, and infliximab administration route are recommended. Rapid assays and home sampling strategies offer flexibility for point-of-care TDM. Ongoing studies on model-informed precision dosing in inflammatory bowel disease will help assess the additional value of precision dosing software tools. Patient education and empowerment, and electronic health record–integrated TDM solutions will facilitate routine TDM implementation. Although optimization of therapeutic effectiveness is a primary focus, the cost-reducing potential of TDM also merits consideration. Conclusions: Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.

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“…However, several studies reported differences in the absolute drug concentrations, and this can impact clinical practice when thresholds or ranges of concentration are the target to reach by TDM [ 18 , 19 , 20 ]. Regarding ADA monitoring assays, associations have been reported, with correlation coefficients ranging from 0.54 to 0.99 [ 17 , 18 , 21 ]. Nevertheless, the different capacities of available assays to detect ADAs in the presence of the drug can lead to differences in sensitivity [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Drug Monitoring of Anti-TNFα Inhibitors: A Matter of Cut-Off Ranges

et al. 2023

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Therapeutic drug monitoring (TDM) is a useful tool for optimising the use of anti-TNFα inhibitors in patients with inflammatory bowel diseases (IBDs). Recently, point-of-care methods for the quantification of drug levels and anti-drug antibodies (ADAs) have been developed to overcome the limitations of conventional enzyme-linked immunoabsorbent assays (ELISAs). Here, we evaluated the performance, interchangeability, and agreement between an automated ELISA-based immunoassay (CHORUS Promonitor) and the lateral flow assay (RIDA®QUICK) for the quantification of infliximab (IFX, n = 65) and adalimumab (ADM, n = 58) plasma levels in IBD patients. Thirty-two samples for IFX and twenty-three samples for ADM that tested positively for the presence of ADAs were also used. Overall, data analysis showed a good agreement of ADM trough concentrations (R2 = 0.75) between the two assays as well as for ADA measurement (K > 0.8). However, IFX levels highlighted a weak correlation (R2 = 0.58) between the two kits, with the RIDA®QUICK assay overestimating IFX plasma values by 30% when compared to the CHORUS Promonitor kit. Results from this study show that the two assays are not quantitatively and qualitatively interchangeable due to substantial discrepancies in some results. Accordingly, the same assay should be used for the longitudinal follow-up of IBD patients.

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Comparison of three commercially available ELISA assays for anti-infliximab antibodies

Cited by 7 publications

References 20 publications

Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study

Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Therapeutic Drug Monitoring of Anti-TNFα Inhibitors: A Matter of Cut-Off Ranges

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