Overview of therapeutic drug monitoring of immunosuppressive drugs: Analytical and clinical practices

2021 ◽  
pp. 114315
Author(s):  
Behrouz Seyfinejad ◽  
Abolghasem Jouyban
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Clinical Practices

scholarly journals Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1832
Author(s):  
Angela W.S. Fung ◽  
Michael J. Knauer ◽  
Ivan M. Blasutig ◽  
David A. Colantonio ◽  
Vathany Kulasingam
Keyword(s):  
Regression Analysis ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Transplant Rejection ◽  
Organ Transplant ◽  
Drug Efficacy ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Deming Regression ◽  
Roche Cobas

Background:  Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplant rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to assess method suitability and limitations. Methods: Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot comparisons were assessed. Results: Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer’s claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). Deming regression analysis of method comparisons with the ARCHITECT immunoassay yielded slopes of 0.917 (95%CI: 0.885-0.949) and r of 0.985 for CSA, 0.938 (95%CI: 0.895-0.981) and r of 0.974 for TAC, and 0.842 (0.810-1.110) and r of 0.982 for SRL. Deming regression analysis of comparisons with the LC–MS/MS method yielded slopes of 1.331 (95%CI: 1.167-1.496) and r of 0.969 for CSA, 0.924 (95%CI: 0.843-1.005) and r of 0.984 for TAC, and 0.971 (95%CI: 0.913-1.030) and r of 0.993 for SRL. Conclusions: The cobas e 411 ECLIA for CSA, TAC, and SRL have acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC–MS/MS and is fit for therapeutic drug monitoring

scholarly journals Prospective investigations of concentration–clinical response for immunosuppressive drugs provide the scientific basis for therapeutic drug monitoring

1998 ◽  
Vol 44 (2) ◽  
pp. 381-387 ◽  
Author(s):  
Leslie M Shaw ◽  
Bruce Kaplan ◽  
Kenneth L Brayman
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Clinical Response ◽  
Drug Monitoring ◽  
Immunosuppressive Drugs ◽  
Scientific Basis ◽  
Therapeutic Drug ◽  
Controlled Clinical Trial ◽  
Target Drug ◽  
Drug Concentrations ◽  
The Individual

Abstract The performance of prospective concentration–clinical response investigations during the early stages of the development of new therapeutic agents can provide a more rigorous basis for therapeutic drug monitoring than the traditional retrospective review of drug concentrations vs clinical outcome. Here we discuss the application of the multicenter randomized concentration-controlled clinical trial study design, and related study designs, as applied to older commonly used and monitored drugs and to two new immunosuppressant drugs, mycophenolate mofetil and tacrolimus. Such studies can provide a more rigorous basis for assessing the risk/benefit associated with a target drug concentration in the individual patient and for designing future prospective pharmacokinetic and therapeutic drug monitoring investigations.

Knowledge of immunosuppressive drugs used in kidney transplants

2012 ◽  
Vol 21 (13) ◽  
pp. 795-800
Author(s):  
Mas Linda Mohamad ◽  
Li Yang ◽  
Xu Jin ◽  
Priscilla Tan Lee Eng ◽  
Terence Kee Yi Shern
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Kidney Transplant ◽  
Drug Monitoring ◽  
Education Programme ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Kidney Transplant Recipients ◽  
Transplant Patients ◽  
High Dependency ◽  
Kidney Transplant Patients

Aim: A key role of renal nurses is the correct and safe administration of immunosuppressive drug therapy (ImmRx) to kidney transplant recipients. The authors sought to examine the knowledge and competency of ImmRx in kidney transplant patients and whether an annual kidney transplant nurse education programme had any beneficial effects. Methods: The study population was comprised of 63.2% (n=50/79) of all nurses from renal wards (ward A (n=17/35), ward B (n=21/32)) and 12 nurses from a high-dependency urology ward (ward C (n=12)). Kidney transplant patients usually receive inpatient care in wards A, B or C only as these wards specialise in urology and renal care. Each nurse completed a 35-question test that covered ImmRx in areas of indication, identification, interaction, pharmcokinetics/pharmacodynamics, therapeutic drug monitoring, administration and adverse effects. A minimum score of 70% was required to pass the test. Results: Only 46% of participants passed the test. The proportion of nurses who passed was not significantly different with respect to years of nursing experience, professional rank, postgraduate nursing qualifications or ward location. Unexpectedly, a greater proportion of nurses who did not attend the education programme passed the test (63.6%; n=14/22) than those who did attend it (32.1%; n=9/28]; p=0.03). Notably, 24% (n=12/50), 4% (n=2/50) and 4% (n=2/50) were unable to correctly answer any of the identification, interaction and therapeutic drug monitoring questions. Conclusion: These findings suggest that the nurses' understanding and knowledge of ImmRx is insufficient and they need to update their knowledge on ImmRx continually.

scholarly journals Point-of-Care Therapeutic Drug Monitoring for Precision Dosing of Immunosuppressive Drugs

2020 ◽  
Vol 5 (4) ◽  
pp. 738-761 ◽  
Author(s):  
Adriano Taddeo ◽  
Denis Prim ◽  
Elena-Diana Bojescu ◽  
Jean-Manuel Segura ◽  
Marc E Pfeifer
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Clinical Decision Making ◽  
Point Of Care ◽  
Clinical Care ◽  
Transplant Rejection ◽  
Area Under The Curve ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Pharmacokinetic Data

Abstract Background Immunosuppressive drugs (ISD) are an essential tool in the treatment of transplant rejection and immune-mediated diseases. Therapeutic drug monitoring (TDM) for determination of ISD concentrations in biological samples is an important instrument for dose personalization for improving efficacy while reducing side effects. While currently ISD concentration measurements are performed at specialized, centralized facilities, making the process complex and laborious for the patient, various innovative technical solutions have recently been proposed for bringing TDM to the point-of-care (POC). Content In this review, we evaluate current ISD-TDM and its value, limitations, and proposed implementations. Then, we discuss the potential of POC-TDM in the era of personalized medicine, and provide an updated review on the unmet needs and available technological solutions for the development of POC-TDM devices for ISD monitoring. Finally, we provide concrete suggestions for the generation of a meaningful and more patient-centric process for ISD monitoring. Summary POC-based ISD monitoring may improve clinical care by reducing turnaround time, by enabling more frequent measurements in order to obtain meaningful pharmacokinetic data (i.e., area under the curve) faster reaction in case of problems and by increasing patient convenience and compliance. The analysis of the ISD-TDM field prompts the evolution of POC testing toward the development of fully integrated platforms able to support clinical decision-making. We identify 4 major areas requiring careful combined implementation: patient usability, data meaningfulness, clinicians’ acceptance, and cost-effectiveness.

Current opinions on therapeutic drug monitoring of immunosuppressive drugs

1999 ◽  
Vol 21 (10) ◽  
pp. 1632-1652 ◽  
Author(s):  
Leslie M. Shaw ◽  
David W. Holt ◽  
Paul Keown ◽  
Raman Venkataramanan ◽  
Randall W. Yatscoff
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug

scholarly journals THERAPEUTIC DRUG MONITORING OF IMMUNOSUPPRESSIVE DRUGS IN HEPATOLOGY AND GASTROENTEROLOGY

2021 ◽  
pp. 101756
Author(s):  
Suwasin udomkarnjananun ◽  
Marith I. Francke ◽  
Brenda C.M. De Winter ◽  
Midas B. Mulder ◽  
Carla C. Baan ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug
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