scholarly journals Rapid point-of-care anti-infliximab antibodies detection in clinical practice: comparison with ELISA and potential for improving therapeutic drug monitoring in IBD patients

2021 ◽  
Vol 14 ◽  
pp. 175628482199990
Author(s):  
Sonia Facchin ◽  
Andrea Buda ◽  
Romilda Cardin ◽  
Nada Agbariah ◽  
Fabiana Zingone ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Point Of Care ◽  
Drug Clearance ◽  
Elisa Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Therapeutic Drug ◽  
Drug Concentrations ◽  
Inflammatory Bowel

Anti-drug antibodies can interfere with the activity of anti-tumor necrosis factor (TNF) agents by increasing drug clearance via direct neutralization. The presence of anti-drug antibodies is clinically relevant when trough drug concentrations are undetectable or sub-therapeutic. However, traditional immunoassay is not easily and rapidly accessible, making the translation of the results into treatment adjustment difficult. The availability of a point-of-care (POC) test for therapeutic drug monitoring (TDM) might represent an important step forward for improving the management of inflammatory bowel disease (IBD) patients in clinical practice. In this pilot study, we compared the results obtained with POC tests with those obtained by enzyme-linked immunosorbent assay (ELISA) in a group of IBD patients treated with Infliximab (IFX). We showed that POC test can reliably detect presence of antibody-to-IFX with 100% of specificity and 76% sensitivity, in strong agreement with the ELISA test ( k-coefficient = 0.84).

scholarly journals Therapeutic Drug Monitoring in Fungal Infections: the Dawn of Proactive Monitoring

2021 ◽  
Author(s):  
Joan Antoni Schoenenberger-Arnaiz ◽  
Ana Aragones-Eroles ◽  
Pilar Taberner-Bonastre ◽  
Arturo Morales-Portillo
Keyword(s):  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Fungal Infections ◽  
Antifungal Drugs ◽  
Therapeutic Drug ◽  
Clinical Settings ◽  
Drug Concentrations ◽  
Direct Exposure ◽  
Consensus Statements

Therapeutic Drug Monitoring (TDM) is potentially a useful tool that can be employed to increase the efficacy and decrease the toxicity of antifungal drugs. The aim of this narrative review is to provide an overview of the current use of TDM in clinical practice, and to present the evidence available regarding its use in proactive clinical settings for preventing and managing treatment failure. This review also presents the existing evidence regarding the association of various clinical outcomes with specific thresholds of drug concentrations in everyday practice. Articles concerning the use of TDM of triazoles in the treatment of fungal infections were retrieved through an electronic search using PubMed. In clinical practice, TDM has an increasingly important role in the management of antifungal drugs as a consequence of the improvement in the knowledge of the pharmacokinetics and pharmacodynamics of these drugs. The currently available evidence shows a direct exposure-response relationship for triazoles, though the PK/PD profile is unpredictable. Current guidelines and treatment consensus statements recommend the proactive TDM of voriconazole, posaconazole, and itraconazole to optimize dosage regimens and improve outcomes for adult and pediatric patients.

scholarly journals INDUCTION THERAPEUTIC DRUG MONITORING REGIMEN WITH INFLIXIMAB: A SIMPLIFIED EVIDENCE-BASED ALGORITHM FOR INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 57 (4) ◽  
pp. 507-510
Author(s):  
Natália Sousa Freitas QUEIROZ ◽  
Fábio Vieira TEIXEIRA ◽  
Rogerio Serafim PARRA ◽  
Paulo Gustavo KOTZE
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Clinical Decision Making ◽  
Maintenance Phase ◽  
Clinical Decision ◽  
Therapeutic Drug ◽  
Induction Phase ◽  
Simplified Approach ◽  
Drug Concentrations ◽  
Inflammatory Bowel

ABSTRACT Therapeutic drug monitoring (TDM) of infliximab (IFX) has been recognized as an important strategy in the management of secondary loss of response to this agent, guiding clinical decision-making in the management of inflammatory bowel diseases (IBD). Although most of the data on the application of TDM for IFX refer to the maintenance phase of treatment, many studies have associated higher drug concentrations, specially in the induction phase, with achievement of important treatment targets, such as clinical remission and mucosal healing. This brief communication aims to summarize the literature on the use of TDM during induction phase of IFX and propose application of a simplified approach which can be useful into clinical practice, aiming better outcomes to IBD patients.

Therapeutic Drug Monitoring and Pharmacogenetic Tests in Pharmacovigilance - When and What?

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
E. Jaquenoud Sirot ◽  
P. Baumann
Keyword(s):  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Adverse Drug Reactions ◽  
Drug Monitoring ◽  
Type A ◽  
Clinical Situation ◽  
Therapeutic Drug ◽  
Drug Reactions ◽  
Drug Concentrations ◽  
Unnecessary Testing

More than 80% of all adverse drug reactions are Type A reactions and dependent on drug concentrations. Therapeutic Drug Monitoring (TDM), Drug Interaction checking programs and pharmacogenetic tests are valuable instruments in elucidating or preventing Type A reactions. It stands for Quality Assurance in clinical practice. The TDMplus algorithm (Jaquenoud Sirot E et al 2006) is helpful in clinical practice and prevents unnecessary testing. This decision tree leads in several “stop/go” steps from the clinical situation of inefficacy or adverse reaction to measuring and interpreting plasma levels, checking for pharmacokinetic interactions and finally, if indicated, to pharmacogenetic tests with gentoyping and/or phenotyping. Genetic results are noted on a personal “pharmacogenetic card” for the patient's future treatments.The interplay of genetics, drug interactions, life style and other personal vulnerabilities like comorbidity make prediction of drug response very complex. The use of TDMplus has proven useful guiding the clinicians in difficult clinical situations and helping elucidating the causality of adverse drug reactions. Its practical benefit has been shown with pharmacovigilance cases from the AMSP program (Arzneimittelsicherheit in der Psychiatrie = Drug Safety in Psychiatry).

scholarly journals Biosensor-enabled on-site therapeutic drug monitoring of antibiotics

2021 ◽  
Author(s):  
Can Dincer ◽  
Hatice Ceren Ates ◽  
Hasti Mohsenin ◽  
Christin Wenzel ◽  
Regina Glatz ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Point Of Care ◽  
Exhaled Breath Condensate ◽  
Plasma Concentrations ◽  
Therapeutic Drug ◽  
Optimal Dosage ◽  
Large Animal ◽  
Exhaled Breath ◽  
Drug Concentrations

Abstract Antimicrobial resistance is increasing with an alarming rate for which the prime suspect is the “one size-fits-all” dosage strategies of antibiotics. Personalized antibiotherapy framework appears as a viable option to counteract inadequate dosage, as it offers the application of the optimal dosage regimen for each individual. Such individualized scheme, however, needs frequent sampling to tailor the blood antibiotic concentration to respond unique pharmacokinetic/pharmacodynamic (PK/PD) of the patient. Herein, there are two alternative paths for feasible therapeutic drug monitoring (TDM); transforming our understanding to utilize blood based sampling within the scope of point-of-care (POC), or focusing on non-invasive samples. Here, we present a versatile biosensor along with an antibody-free assay that can be utilized in both paths for on-site TDM. The developed platform is evaluated in a large animal study (pigs exposed with overdose, normal dose, and underdose of ß lactams), in which antibiotic concentrations are quantified in matrices including whole blood, plasma, urine, saliva, and exhaled breath condensate (EBC). Herein, the detection and the clearance of drug concentrations in EBC is demonstrated for the first time. Influence of the secretion mechanisms on measured drug concentrations is then quantified by comparing the plasma concentrations with those in EBC, saliva and urine. The potential of the developed platform for blood-based POC application is further illustrated by tracking ß lactam concentrations in untreated blood samples. Finally, multiplexing capabilities are explored successfully for multianalyte/sample analysis. Enabling a rapid, low-cost, sample-independent, and multiplexed on-site TDM, this system could pave the way for the personalized drug therapies and thus, shift the paradigm of “one size-fits-all” strategies.

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