Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab

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

doi:10.3390/jcm9092739

Cited by 13 publications

(13 citation statements)

References 19 publications

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“…Moreover, in case of loss of response where we are likely to optimise dosing, it may be necessary to measure and compare the pharmacokinetics of the 120 mg ew dose vs the 240 mg eow dose as shown with adalimumab 5 . Finally, the contribution of rapid point of care (POC) tests could facilitate the TDM of these subcutaneous treatments, but it seems crucial to first establish and validate thresholds specific to these devices given that POCs tend to overestimate biotherapy trough levels as has been demonstrated with the intravenous agents 6–8 …”

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confidence: 99%

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Editorial: is there a role for monitoring intermediate anti‐TNF drug concentrations in IBD? Authors’ reply

Roblin

Paul

2022

Aliment Pharmacol Ther

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We read with great interest the editorial by Profs Rakowsky, Papamichael and Cheifetz in response to our recently published study on therapeutic drug monitoring (TDM) of subcutaneous CT-P13. 1,2 We agree with the vast majority of the comments made. 3 Indeed, our study is a first step in demonstrating whether TDM is useful in monitoring subcutaneous biotherapies. It is now necessary to establish predictive factors of non-response for subcutaneous anti-TNF agents and to evaluate them in a proactive interventional study based on the newly established cut-off. It is likely that the immunogenicity conferred by this route will be relatively low and that we are unlikely to have to evaluate combotherapy regimens. Our cohort was highly selected by discarding pejorative factors known to increase the clearance of the biotherapy (high BMI, low albumin and high inflammation status). It seems important to study the pharmacokinetics in these specific populations. It is also essential, as the editorialists noted, to analyse using drug-tolerant assays, the early development of antibodies after subcutaneous treatment and particularly in patients already immunised after intravenous IFX. Switch to subcutaneous formulations has been associated with the reduction of anti-IFX antibodies in patients already immunised and/or with infusion reactions. 4 Moreover, in case of loss of response where we are likely to optimise dosing, it may be necessary to measure and compare the pharmacokinetics of the 120 mg ew dose vs the 240 mg eow dose as shown with adalimumab. 5 Finally, the contribution of rapid point of care (POC) tests could facilitate the TDM of these subcutaneous treatments, but it seems crucial to first establish and validate thresholds specific to these devices given that POCs tend to overestimate biotherapy trough levels as has been demonstrated with the intravenous agents. [6][7][8]

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confidence: 99%

“…5 Finally, the contribution of rapid point of care (POC) tests could facilitate the TDM of these subcutaneous treatments, but it seems crucial to first establish and validate thresholds specific to these devices given that POCs tend to overestimate biotherapy trough levels as has been demonstrated with the intravenous agents. [6][7][8]…”

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confidence: 99%

Editorial: is there a role for monitoring intermediate anti‐TNF drug concentrations in IBD? Authors’ reply

Roblin

Paul

2022

Aliment Pharmacol Ther

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“…Most commercial kits for quantitation of adalimumab are ELISA-based although point-of-care testing kits (LFI) which are rapid and offer a distinct advantage over other methods have also become available and could be integrated into routine clinical practice (77). However, novel quantitative approaches are also being explored in several laboratories (78,79).…”

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confidence: 99%

The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring

et al. 2021

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The expanded availability of adalimumab products continues to widen patient access and reduce costs with substantial benefit to healthcare systems. However, the long-term success of these medicines is highly dependent on maintaining consistency in quality, safety and efficacy while minimizing any risk of divergence during life-cycle management. In recognition of this need and demand from global manufacturers, the World Health Organization (WHO) Expert Committee on Biological standardization established the WHO 1st International standard (IS) for Adalimumab (coded 17/236) in October 2019 with a defined unitage ascribed to each of the individual bioactivities evaluated in the study namely, TNF-α binding, TNF-α neutralization, complement dependent cytotoxicity and antibody-dependent cellular cytotoxicity. For development of the IS, two candidate standards were manufactured as per WHO recommendations. Analysis of extensive datasets generated by testing of a common set of samples including the candidate standards by multiple stakeholders including regulatory agencies using their own qualified assays in a large international collaborative study showed comparable biological activity for the tested candidates for the different activities. Use of a common standard significantly decreased the variability of bioassays and improved agreement in potency estimates. Data from this study clearly supports the utility of the IS as an important tool for assuring analytical assay performance, for bioassay calibration and validation, for identifying and controlling changes in bioactivity during life-cycle management and for global harmonization of adalimumab products. In addition, in a separate multi-center study which included involvement of hospital and clinical diagnostic laboratories, the suitability of the adalimumab IS for therapeutic drug monitoring assays was examined by analysis of data from testing of a common blind coded panel of adalimumab spiked serum samples representative of the clinical scenario along with the IS and in-house standards in diverse immunoassays/platforms. Both commercially available and in-house assays that are routinely used for assessing adalimumab trough levels were included. Excellent agreement in estimates for adalimumab content in the spiked samples was observed regardless of the standard or the method with inter-laboratory variability also similar regardless of the standard employed. This data, for the first time, provides support for the extended applicability of the IS in assays in use for therapeutic drug monitoring based on the mass content of the IS. The adalimumab IS, in fulfilling clinical demand, can help toward standardizing and harmonizing clinical monitoring assays for informed clinical decisions and/or personalized treatment strategies for better patient outcomes. Collectively, a significant role for the adalimumab IS in assuring the quality, safety and efficacy of adalimumab products globally is envisaged.

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“…They are rapid assays carried out at the point where care is provided, making accurate results feasible within minutes. Regarding TCs measurement, POC assays exhibit high correlation with standard ELISA, with an overall agreement of up to 89.4% [ 102 , 103 ]. Moreover, POC tests can detect Abs accurately and reliably enough, with 100% specificity and 76% sensitivity, and their results are highly correlated with those from the ELISA assays too [ 104 ].…”

Section: Therapeutic Drug Monitoring (Tdm)mentioning

confidence: 99%

Recent Advances in the Optimization of Anti-TNF Treatment in Patients with Inflammatory Bowel Disease

Orfanoudaki

Foteinogiannopoulou

Theodoraki

et al. 2023

JCM

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Despite the evolution in inflammatory bowel disease (IBD) management during the last 20 years owing to the advent of new advanced therapies, anti-TNF agents still remain the cornerstone of therapy for both Crohn’s disease and ulcerative colitis. However, this does not only secure favorable outcomes for patients considering the progressive disease character and the high likelihood of primary or secondary loss of response. Therefore, trying to reach a better treatment approach and maximize the benefits anti-TNF agents offer, optimization strategies should be examined. It has been indicated that optimizing treatment with anti-TNF enhances drug efficacy and has been associated with improved disease outcomes and a complication-free disease course. From this perspective, we aim to provide an overview of currently available data and recent advances in the practices of anti-TNF treatment optimization. Special focus has been given to the role of therapeutic drug monitoring (TDM), as well as the utility of combining anti-TNF with an immunomodulator and the treat-to-target approach.

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Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab

Cited by 13 publications

References 19 publications

Editorial: is there a role for monitoring intermediate anti‐TNF drug concentrations in IBD? Authors’ reply

Editorial: is there a role for monitoring intermediate anti‐TNF drug concentrations in IBD? Authors’ reply

The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring

Recent Advances in the Optimization of Anti-TNF Treatment in Patients with Inflammatory Bowel Disease

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