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Biomedicines
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Advances in Therapeutic Drug Monitoring
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Advances in Therapeutic Drug Monitoring

A special issue of Biomedicines (ISSN 2227-9059). This special issue belongs to the section "Drug Discovery, Development and Delivery".

Deadline for manuscript submissions: closed (31 May 2024) | Viewed by 11993

Special Issue Editor

Dr. Giuliana Cangemi

E-Mail Website
Guest Editor
IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy
Interests: clinical mass spectrometry; therapeutic drug monitoring
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Therapeutic drug monitoring (TDM) is a field of laboratory medicine related to the personalization of therapies. By combining knowledge of pharmaceutics, pharmacokinetics, and pharmacodynamics, TDM enables the assessment of the efficacy and safety of a particular medication in a variety of clinical settings.  TDM involves measuring drug concentrations in various biological fluids and interpreting these concentrations in terms of relevant clinical parameters. Expert interpretation of a drug concentration is essential to ensuring full clinical benefit. 

This Special Issue intends to gather in one place both recent methodological advances and specific studies that have extended the use of TDM. In particular, this Special Issue is focused on the description of TDM studies in fragile or special populations (e.g., pediatrics). Papers that explore new analytical methods based on advanced chromatographic and mass spectrometric technologies that enable the measurement of drugs also from alternative matrices and micro sampling are welcome. The Special Issue is expected to be of interest to pharmacologists, chemists, biologists, as well as physicians involved in this science.

Dr. Giuliana Cangemi
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Biomedicines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • therapeutic drug monitoring
  • pharmacokinetics
  • drug
  • blood levels
  • microsampling
  • analytical methods
  • fragile patients
  • special population
  • pediatrics
  • rare diseases

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Published Papers (5 papers)

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Research

11 pages, 864 KiB  
Article
Observational Study to Compare Biological Drug Concentration Quantification Techniques and Immunogenicity in Patients with Immune-Mediated Diseases
by Alejandro Martínez-Pradeda, Laida Elberdín, Ángeles Porta-Sánchez, María Outeda, Mª Teresa Diz-Lois Palomares, Teresa Vázquez-Rey, Benito González-Conde, Emilio Estévez-Prieto, María I. Gómez-Besteiro and Isabel Martín-Herranz
Biomedicines 2024, 12(4), 839; https://doi.org/10.3390/biomedicines12040839 - 10 Apr 2024
Viewed by 1047
Abstract
Measuring biological drugs’ trough concentrations and the concentrations of anti-drug antibodies is a valuable practice for treatment optimization. ELISA techniques are the gold standard for biological drug concentration quantification, but new techniques such as chemiluminescence immunoassays present some advantages. The aim of this [...] Read more.
Measuring biological drugs’ trough concentrations and the concentrations of anti-drug antibodies is a valuable practice for treatment optimization. ELISA techniques are the gold standard for biological drug concentration quantification, but new techniques such as chemiluminescence immunoassays present some advantages. The aim of this unicentric prospective observational study is to compare the infliximab, adalimumab, vedolizumab and ustekinumab trough levels and anti-adalimumab and anti-infliximab antibodies concentrations obtained when using a chemiluminescent instrument (i-TRACK®, Theradiag, Croissy-Beaubourg, France) and an ELISA instrument (TRITURUS®, Griffols, Barcelona, Spain). Linear regression, Pearson or Spearman tests, Bland–Altman plots and the Cohen kappa test were applied for every sample. The correlation was excellent for both assays in the measurement of all drug concentrations. In general, values were lower when measured using i-TRACK than when using TRITURUS, especially when the values were high. Both techniques proved valuable in clinical practice for monitoring adalimumab and infliximab drug concentration. However, the results were modest for ustekinumab and vedolizumab, so caution is recommended and further research is needed. The limited number of anti-drug antibody-positive samples precluded a comparison between the techniques. Full article
(This article belongs to the Special Issue Advances in Therapeutic Drug Monitoring)
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15 pages, 2014 KiB  
Article
Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial
by Karoline Soares Garcia, Matheus Freitas Cardoso de Azevedo, Alexandre de Sousa Carlos, Luísa Leite Barros, Jane Oba, Carlos Walter Sobrado Junior, Aytan Miranda Sipahi, Olívia Duarte de Castro Alves, Tomás Navarro-Rodriguez, Rogério Serafim Parra, Júlio Maria Fonseca Chebli, Liliana Andrade Chebli, Cristina Flores, Andrea Vieira, Christianne Damasceno Arcelino do Ceará, Natália Sousa Freitas Queiroz and Aderson Omar Mourão Cintra Damião
Biomedicines 2023, 11(6), 1757; https://doi.org/10.3390/biomedicines11061757 - 19 Jun 2023
Cited by 4 | Viewed by 2095
Abstract
Therapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remission rates [...] Read more.
Therapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remission rates at six months in Brazilian inflammatory bowel disease (IBD) patients following a proactive TDM algorithm guided by IFX trough levels (ITL) and antibodies to IFX (ATI) levels during induction, at week six. A total of 111 IBD patients were prospectively enrolled, excluding those previously exposed to the drug. ITL ≥ 10 μg/mL was considered optimal. Patients with suboptimal ITL (<10 µg/mL) were guided according to ATI levels. Those who presented ATI ≤ 200 ng/mL underwent dose intensification in the maintenance phase, and patients with ATI > 200 ng/mL discontinued IFX. In our study, proactive TDM was associated with persistence in the IFX rate at six months of 82.9%. At that time, rates of clinical, biological, and endoscopic remission in patients under IFX treatment were 80.2%, 73.9%, and 48.1%, respectively. Applying a simplified TDM-guided algorithm during induction seems feasible and can help improve patients’ outcomes in clinical practice. Full article
(This article belongs to the Special Issue Advances in Therapeutic Drug Monitoring)
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13 pages, 897 KiB  
Article
Therapeutic Drug Monitoring in Oncohematological Patients: A Fast and Accurate HPLC-UV Method for the Quantification of Nilotinib in Human Plasma and Its Clinical Application
by Vanesa Escudero-Ortiz, Francisco José Rodríguez-Lucena, Gabriel Estan-Cerezo, Esther Mancheño-Maciá, Venancio Conesa-García, Ana García-Monsalve, Leticia Soriano-Irigaray and Andrés Navarro-Ruiz
Biomedicines 2023, 11(3), 947; https://doi.org/10.3390/biomedicines11030947 - 20 Mar 2023
Cited by 3 | Viewed by 2184
Abstract
Nilotinib, a second-generation tyrosine kinase inhibitor, has demonstrated clinical activity in chronic myeloid leukemia. As an exposure–response relationship has been observed for nilotinib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to [...] Read more.
Nilotinib, a second-generation tyrosine kinase inhibitor, has demonstrated clinical activity in chronic myeloid leukemia. As an exposure–response relationship has been observed for nilotinib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to develop and validate a selective and precise high performance liquid chromatography–ultraviolet method for the measurement of nilotinib in plasma from patients with cancer. After protein precipitation extraction with acetonitrile, nilotinib and rilpivirine were separated using isocratic elution on a Tracer Excel 120 ODS C18 column using a mobile phase consisting of a mixture of potassium dihydrogen phosphate-buffered solution (pH 5.5; 0.037 M)–methanol–acetonitrile (45:45:10, v/v/v), pumped at a flow rate of 1.7 mL·min−1. A wavelength of 254 nm was selected for the quantification of the analyte and the internal standard (IS). The technique was validated following the guidelines for the validation of analytical methods of regulatory agencies (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). Linearity was established in a concentration range between 125 and 7000 ng/mL. The detection limit was 90 ng/mL, and the lower limit of quantification was 125 ng/mL. For all concentrations in the calibration curve, the intraday and interday coefficients of variation were less than 4.1%. Median recovery of nilotinib from plasma was ≥65.1% (±21.4%). The method described is sensitive, selective, reproducible, and rapid, and can be used for the accurate determination of nilotinib in human plasma for pharmacokinetics studies and for therapeutic drug monitoring (TDM) of nilotinib in routine clinical practice. Full article
(This article belongs to the Special Issue Advances in Therapeutic Drug Monitoring)
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11 pages, 1411 KiB  
Article
Simultaneous Quantification of Ivacaftor, Tezacaftor, and Elexacaftor in Cystic Fibrosis Patients’ Plasma by a Novel LC–MS/MS Method
by Federica Pigliasco, Alessia Cafaro, Manuela Stella, Giammarco Baiardi, Sebastiano Barco, Nicoletta Pedemonte, Claudia D’Orsi, Federico Cresta, Rosaria Casciaro, Carlo Castellani, Maria Grazia Calevo, Francesca Mattioli and Giuliana Cangemi
Biomedicines 2023, 11(2), 628; https://doi.org/10.3390/biomedicines11020628 - 20 Feb 2023
Cited by 10 | Viewed by 2756
Abstract
The new breakthrough cystic fibrosis (CF) drug combination of ivacaftor (IVA), tezacaftor (TEZ), and elexacaftor (ELX), namely “caftor” drugs, directly modulates the activity and trafficking of the defective CF transmembrane conductance regulator protein (CFTR) underlying the CF disease. The role of therapeutic drug [...] Read more.
The new breakthrough cystic fibrosis (CF) drug combination of ivacaftor (IVA), tezacaftor (TEZ), and elexacaftor (ELX), namely “caftor” drugs, directly modulates the activity and trafficking of the defective CF transmembrane conductance regulator protein (CFTR) underlying the CF disease. The role of therapeutic drug monitoring (TDM) of caftor drugs in clinical settings has recently been established. The availability of reliable and robust analytical methods for the quantification of IVA, TEZ, and ELX is essential to support dose–concentration–effect studies. We have developed and validated a new liquid chromatography–tandem mass spectrometry (LC–MS/MS) for the rapid and simultaneous quantification of IVA, TEZ, and ELX from the plasma of CF patients. The method was based on a rapid extraction protocol from 50 μL human plasma and separation on a reversed-phase C-18 HPLC column after the addition of deuterated internal standards. Accurate analyte quantification using multiple reaction monitoring (MRM) detection was then obtained using a Thermofisher Quantiva triple-quadrupole MS coupled to an Ultimate 3000 UHPLC. The method has been validated following international (EMA) guidelines for bioanalytical method validation and has been tested on plasma samples from 62 CF patients treated with the three-drug combination IVA/TEZ/ELX, marketed as Kaftrio® or Trikafta®, in steady-state condition. The assay was linear over wide concentration ranges (0.008–12 mg/L) in plasma for IVA, TEZ, and ELX, suitable for a broad range of plasma concentrations, and accurate and reproducible in the absence of matrix effects. The stability of analytes for at least 30 days at room temperature could allow for cost-effective shipment and storage. On the same day of sample collection, a sweat test was evaluated for 26 associated patients’ samples, FEV1 (%) for 58, and BMI was calculated for 62. However, Spearman correlation showed no correlation between Cthrough plasma concentrations of analytes (IVA, TEZ, ELX) and sweat test, FEV1 (%), or BMI. Our method proved to be suitable for TDM and could be helpful in assessing dose–concentration–response correlations in larger studies. Full article
(This article belongs to the Special Issue Advances in Therapeutic Drug Monitoring)
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12 pages, 822 KiB  
Article
Development and Validation of a Novel LC-MS/MS Method for a TDM-Guided Personalization of HSCT Conditioning with High-Dose Busulfan in Children
by Alessia Cafaro, Federica Pigliasco, Giammarco Baiardi, Sebastiano Barco, Manuela Stella, Roberto Bandettini, Francesca Mattioli, Maura Faraci and Giuliana Cangemi
Biomedicines 2023, 11(2), 530; https://doi.org/10.3390/biomedicines11020530 - 11 Feb 2023
Cited by 2 | Viewed by 2476
Abstract
Personalization of busulfan (Bu) exposure via therapeutic drug monitoring (TDM) is recommended for patients treated with high-dose conditioning regimens. Several laboratories’ developed methods are available in the literature with a lack of standardization. The aim of this study is to develop a new [...] Read more.
Personalization of busulfan (Bu) exposure via therapeutic drug monitoring (TDM) is recommended for patients treated with high-dose conditioning regimens. Several laboratories’ developed methods are available in the literature with a lack of standardization. The aim of this study is to develop a new standardized LC-MS/MS method and validate it according to the international ICH M10 (EMA) guidelines. Our method is based on rapid protein precipitation from 50 µL plasma followed by separation on a reversed-phase C-18 UHPLC column after the addition of deuterated internal standard and has been tested on real samples from pediatric patients treated with myeloablative conditioning regimens, including Bu, before autologous or allogeneic hematopoietic stem cell transplantation (HSCT). The validated LC-MS/MS method is linear over wide concentration ranges (125–2000 ng/mL), accurate, and reproducible in the absence of matrix effects, allowing for the specific and rapid quantification of Bu and allowing next-dose recommendations to be made in a timely fashion to answer clinicians’ needs. Given the lack of data on the stability of Bu in real clinical samples, stability was assessed both on quality controls and on real samples to set up a robust protocol in real-life conditions. This novel LC-MS/MS method is suitable for application to the TDM-guided personalization of conditioning treatments with high-dose busulfan in pediatric patients undergoing HSCT. Full article
(This article belongs to the Special Issue Advances in Therapeutic Drug Monitoring)
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