Comparison of Point-of-Care and Classical Immunoassays for the Monitoring Infliximab and Antibodies Against Infliximab in IBD

Nasser, Yara; Labetoulle, Rémi; Harzallah, Inès; Berger, Anne‐Emmanuelle; Roblin, Xavier; Paul, Stéphane

doi:10.1007/s10620-018-5144-y

Cited by 48 publications

(43 citation statements)

References 34 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 …”

mentioning

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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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%

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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“…67 Today, CE-marked POC LF immunoassays are available to quantify infliximab, anti-infliximab antibodies and adalimumab in patients' serum. [68][69][70][71][72][73] However, the need to apply serum instead of full blood requires sample preparation and thus hinders a widespread on-site use of these POC assays.…”

Section: Proactive Testing and Dose Optimization : What Is The Evidence?mentioning

confidence: 99%

How, When, and for Whom Should We Perform Therapeutic Drug Monitoring?

Vermeire

Dreesen

Papamichael

et al. 2020

Clinical Gastroenterology and Hepatology

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Point-of-care assays for detecting IFX levels, adalimumab levels, and anti-IFX antibodies are commercially available. However, they are limited by their ability to use serum instead of blood (58)(59)(60). As with other point-of-care tests, there are concerns around quality control, reliability, cost, and external validation.…”

Section: Point-of-care Testingmentioning

confidence: 99%

Advances in Therapeutic Drug Monitoring in Biologic Therapies for Pediatric Inflammatory Bowel Disease

Kapoor

Crowley

2021

Front. Pediatr.

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In the current era of treat-to-target strategies, therapeutic drug monitoring (TDM) has emerged as a potential tool in optimizing the efficacy of biologics for children diagnosed with inflammatory bowel disease (IBD). The incorporation of TDM into treatment algorithms, however, has proven to be complex. “Proactive” TDM is emerging as a therapeutic strategy due to a recently published pediatric RCT showing a clear benefit of “proactive” TDM in anti-TNF therapy. However, target therapeutic values for different biologics for different disease states [ulcerative colitis (UC) vs. Crohn's disease (CD)] and different periods of disease activity (induction vs. remission) require further definition. This is especially true in pediatrics where the therapeutic armamentarium is limited, and fixed weight-based dosing may predispose to increased clearance leading to decreased drug exposure and subsequent loss of response (pharmacokinetic and/or immunogenic). Model-based dosing for biologics offers an exciting insight into dose individualization thereby minimizing the chances of losing response. Similarly, point-of-care testing promises real-time assessment of drug levels and individualized decision-making. In the current clinical realm, TDM is being used to prolong drug durability and efficacy and prevent loss of response. Ongoing innovations may transform it into a personalized tool to achieve optimal therapeutic endpoints.

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Comparison of Point-of-Care and Classical Immunoassays for the Monitoring Infliximab and Antibodies Against Infliximab in IBD

Cited by 48 publications

References 34 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

How, When, and for Whom Should We Perform Therapeutic Drug Monitoring?

Advances in Therapeutic Drug Monitoring in Biologic Therapies for Pediatric Inflammatory Bowel Disease

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