Letter: new thresholds need to be defined when using point of care assays to monitor infliximab trough levels in <scp>IBD</scp> patients

Dutzer, Dominique; Nasser, Yara; Berger, Anne‐Emmanuelle; Roblin, Xavier; Paul, Stéphane

doi:10.1111/apt.14645

Cited by 12 publications

(13 citation statements)

References 5 publications

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“…We also found that infliximab and adalimumab concentrations before and after the correction of the HMSA were significantly different, both quantitatively and qualitatively. This is in line with previous studies showing discrepancies among assays used for evaluating biologic drug concentrations [8,9,14,15]. Moreover, we identified adalimumab concentration thresholds of 22.4 µg/mL before the corrected measures and 14.4 µg/mL after the corrected measures discriminated patients with or without treatment failure.…”

Section: Discussionsupporting

confidence: 91%

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay

Papamichael

Thomas

Banty

et al. 2020

JCM

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An upward drift for both infliximab and adalimumab concentrations measured by the homogenous mobility shift assay (HMSA) was previously reported. We aimed to investigate the impact of this drift on clinical care of patients with inflammatory bowel disease. This was a retrospective, multicenter study. Providers reviewed the individual patient data and drug concentrations before and after the laboratory corrections and then documented whether a different clinical decision would have been made had the corrected drug concentration been originally reported. A multivariable Cox proportional hazards regression analysis was performed to investigate the association of a documented treatment change with treatment failure, defined as drug discontinuation for primary nonresponse, loss of response, or serious adverse event, adjusting for confounding factors. The study population consisted of 479 patients (infliximab, n = 219; adalimumab, n = 260). Upon review, 14.9% (71/479) patients would have had a different treatment decision made had the corrected drug concentration been initially reported. After a median follow-up of 10.6 months, 25.7% of patients (123/479) had treatment failure. A theoretical different clinical decision based on the corrected drug concentrations was not associated with treatment failure (adjusted hazard ratio (HR): 1.452; 95% confidence interval (CI): 0.805–2.618; p = 0.216), which was consistent for both infliximab (adjusted HR: 1.977; 95% CI: 0.695–5.627; p = 0.201) and adalimumab (adjusted HR: 1.484; 95% CI: 0.721–3.054; p = 0.284). The drift in infliximab and adalimumab concentrations in the HMSA assay affected treatment decisions in 15% of cases. However, this discrepancy was not associated with a higher cumulative probability for treatment failure.

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Section: Discussionsupporting

confidence: 91%

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay

Papamichael

Thomas

Banty

et al. 2020

JCM

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“…32,145 However, as the number of such tests increases, their quality needs to be assessed and their accuracy compared with the commonly used laboratory measurements of drug concentrations and ADA to check for potential discrepancies. [146][147][148]…”

Section: Point-of-care Assaysmentioning

confidence: 99%

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

Papamichael¹,

Afif²,

Drobne³

et al. 2022

The Lancet Gastroenterology & Hepatology

100

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“…In this way, the point of care (POC) for TDM testing could play a key role in a proactive strategy. In addition, the best threshold values are not yet defined and may differ between POC and ELISA assays 4 . Second, we need skill upgrades for gastroenterologists taking care of IBD patients to better interpret the results of TDM in their daily practice.…”

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confidence: 99%

Editorial: proactive anti‐TNF drug monitoring in IBD—Ready for prime time?

Roblin

Nancey

2023

Aliment Pharmacol Ther

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Letter: new thresholds need to be defined when using point of care assays to monitor infliximab trough levels in IBD patients

Abstract: Linked Content This article is linked to Papamichael et al paper. To view this article visit https://doi.org/10.1111/apt.14458.

Cited by 12 publications

References 5 publications

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

Editorial: proactive anti‐TNF drug monitoring in IBD—Ready for prime time?

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