Comparison of Assays for Therapeutic Monitoring of Infliximab and Adalimumab in Patients With Inflammatory Bowel Diseases

Papamichael, Konstantinos; Clarke, William T; Casteele, Niels Vande; Germansky, Katharine A.; Feuerstein, Joseph D.; Melmed, Gil Y.; Siegel, Corey A.; Irving, Peter M.; Cheifetz, Adam S.

doi:10.1016/j.cgh.2020.03.002

Cited by 16 publications

(19 citation statements)

References 8 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: 92%

“…However, these thresholds can vary depending on the targeted clinical outcome, IBD phenotype, and TDM assay used [ 7 ]. Regarding the latter, we have previously shown a discrepancy between a commercially available enzyme-linked immunosorbent assay (ELISA) and a commercially available homogeneous mobility shift assay (HMSA), for both infliximab and adalimumab concentrations [ 8 , 9 ]. Based on these results, a comprehensive review of the HMSA assays was initiated and an upward drift for both infliximab (from December 2017 to May 2019) and adalimumab (from August 2017 to May 2019) was found, including the period during which our study was performed.…”

Section: Introductionmentioning

confidence: 99%

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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: 92%

Section: Introductionmentioning

confidence: 99%

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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“…101 Furthermore, data in the past few years have shown that quantitative and qualitative discrepancies might exist among assays for drug concentrations and ADA titres. [129][130][131][132] Regarding IBD phenotypes, preliminary data suggest that patients with perianal fistulising Crohn's…”

Section: Optimal Drug Concentrations To Targetmentioning

confidence: 99%

“…Although drug concentrations correlate well between different assays, their agreement might not always be good; if possible, use of the same assay might be best for individual patient follow-up. [129][130][131]135 Efforts are ongoing to standardise assays for measuring drug concentrations by producing reference standards. Implementation of universal calibrators for quantifying ADA has also been proposed to facilitate interlaboratory harmonisation of ADA measurements.…”

Section: Harmonisation Of Tdm 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

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“…Importantly, higher trough levels do not result in increased risk for infections or other adverse events ( 35 ). It is remarked that there is variability in the performance of the different assays for measurement of the drug levels hampering the comparison of absolute values in different settings ( 36 ). There are less data on the performance of the commercial assays when using biosimilars but according to our experience the results are comparable with infliximab and its biosimilars ( 20 ).…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Drug Monitoring and Outcome of Infliximab Therapy in Pediatric Onset Inflammatory Bowel Disease

Kolho

2021

Front. Pediatr.

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Inflammatory bowel disease (IBD) with pediatric onset has become more prevalent during past decades. Thus, the number of patients with moderate to severe disease subtype treated with antagonists to tumor necrosis factor alpha (TNFα) has concurrently risen. Most pediatric patients initially respond to these drugs but will need dose escalation during the first year of therapy. As pediatric data regarding therapeutic drug monitoring during therapy with TNFα-blocker adalimumab are sparse, this review focuses on the literature on therapeutic drug monitoring of infliximab and how it may guide management.

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Comparison of Assays for Therapeutic Monitoring of Infliximab and Adalimumab in Patients With Inflammatory Bowel Diseases

Cited by 16 publications

References 8 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

Therapeutic Drug Monitoring and Outcome of Infliximab Therapy in Pediatric Onset Inflammatory Bowel Disease

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