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Article ; Online: Pharmacokinetic profile of irinotecan in patients with chronic kidney disease: Two cases and literature review.

Chui, Chang Yue / Moes, Dirk Jan A R / Koolen, Stijn L W / Swen, Jesse J / Gelderblom, Hans

British journal of clinical pharmacology

2023 Volume 89, Issue 9, Page(s) 2920–2925

Abstract: Aims: There are limited pharmacokinetic data on the use of irinotecan in patients with reduced glomerular filtration rate (GFR) and no haemodialysis. In this case report, we present 2 cases and review the current literature.: Methods: The dose of ... ...

Abstract	Aims: There are limited pharmacokinetic data on the use of irinotecan in patients with reduced glomerular filtration rate (GFR) and no haemodialysis. In this case report, we present 2 cases and review the current literature. Methods: The dose of irinotecan in both patients was reduced pre-emptively due to reduced GFR. The first patient had her irinotecan dose reduced to 50%, but was nevertheless admitted to hospital because of irinotecan-induced toxicity, including gastrointestinal toxicity and neutropenic fever. The dose was reduced further to 40% for the second cycle; however, the patient was again admitted to the hospital, and irinotecan was stopped indefinitely. The second patient also had his irinotecan dose reduced to 50% and was admitted to the emergency department for gastrointestinal toxicity after the first cycle. However, irinotecan could be administered in the same dose in later cycles. Results: The area under the curve to infinity of irinotecan and SN-38 in the first patient were comparable to those of an individual receiving 100% dose intensity. The area under the curve to infinity of irinotecan and SN-38 in patient 2 in both cycles were slightly less than reference values. Furthermore, clearance values of irinotecan and SN-38 in our patients were comparable to those without renal impairment. Conclusion: Our case report suggests that reduced GFR may not significantly affect the clearance of irinotecan and SN-38, but can still result in clinical toxicity. Reduced initial dosing seems indicated in this patient population. Further research is needed to fully understand the relationship between reduced GFR, pharmacokinetics, and toxicity of irinotecan and SN-38.
Language	English
Publishing date	2023-07-17
Publishing country	England
Document type	Case Reports
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15833
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Article ; Online: The effect of genetic variants in the transcription factor TSPYL family on the CYP3A4 mediated cyclosporine metabolism in kidney transplant patients.

Zhai, Qinglian / Moes, Dirk Jan A R / van Gelder, Teun / van der Lee, Maaike / Sanders, Jan-Stephan / Bemelman, Frederike J / de Fijter, Johan W / Klein, Kathrin / Schwab, Matthias / Swen, Jesse J

Clinical and translational science

2024 Volume 17, Issue 2, Page(s) e13729

Abstract: CYP3A4 activity shows considerable interindividual variability. Although studies indicate 60%-80% is heritable, common single nucleotide variants (SNVs) in CYP3A4 together only explain ~10%. Transcriptional factors, such as the testis-specific Y-encoded- ... ...

Abstract	CYP3A4 activity shows considerable interindividual variability. Although studies indicate 60%-80% is heritable, common single nucleotide variants (SNVs) in CYP3A4 together only explain ~10%. Transcriptional factors, such as the testis-specific Y-encoded-like proteins (TSPYLs) family, have been reported to regulate the expression of CYP enzymes including CYP3A4 in vitro. Here, we investigated the effect of genetic variants in TSPYL on CYP3A4 activity using data from a clinical study and a human liver bank. Five SNVs (rs3828743, rs10223646, rs6909133, rs1204807, and rs1204811) in TSPYL were selected because of a reported effect on CYP3A4 expression in vitro or suggested clinical effect. For the clinical study, whole blood concentrations, clinical data, and DNA were available from 295 kidney transplant recipients participating in the prospective MECANO study. A multivariate pharmacokinetic model adjusted for body weight, steroid treatment, and CYP3A4 genotype was used to assess the effect of the genetic variants on cyclosporine clearance. In multivariate analysis, homozygous carriers of rs3828743 had a 18% lower cyclosporin clearance compared to the wild-type and heterozygous patients (28.72 vs. 35.03 L/h, p = 0.018) indicating a lower CYP3A4 activity and an opposite direction of effect compared to the previously reported increased CYP3A4 expression. To validate, we tested associations between rs3828743 and CYP3A4 mRNA and protein expression as well as enzyme activity with data from a liver bank (n = 150). No association with any of these end points was observed. In conclusion, the totality of evidence is not in support of a significant role for TSPYL SNV rs3828743 in explaining variability in CYP3A4 activity.
MeSH term(s)	Male ; Humans ; Cyclosporine/pharmacokinetics ; Cytochrome P-450 CYP3A/genetics ; Immunosuppressive Agents/pharmacokinetics ; Transcription Factors/genetics ; Kidney Transplantation/adverse effects ; Prospective Studies ; Genotype ; Polymorphism, Single Nucleotide
Chemical Substances	Cyclosporine (83HN0GTJ6D) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; Immunosuppressive Agents ; Transcription Factors ; CYP3A4 protein, human (EC 1.14.14.55)
Language	English
Publishing date	2024-02-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13729
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Article ; Online: Quantitative modeling of tumor dynamics and development of drug resistance in non-small cell lung cancer patients treated with erlotinib.

Yin, Anyue / Veerman, G D Marijn / van Hasselt, Johan G C / Steendam, Christi M J / Dubbink, Hendrikus Jan / Guchelaar, Henk-Jan / Friberg, Lena E / Dingemans, Anne-Marie C / Mathijssen, Ron H J / Moes, Dirk Jan A R

CPT: pharmacometrics & systems pharmacology

2024 Volume 13, Issue 4, Page(s) 612–623

Abstract: Insight into the development of treatment resistance can support the optimization of anticancer treatments. This study aims to characterize the tumor dynamics and development of drug resistance in patients with non-small cell lung cancer treated with ... ...

Abstract	Insight into the development of treatment resistance can support the optimization of anticancer treatments. This study aims to characterize the tumor dynamics and development of drug resistance in patients with non-small cell lung cancer treated with erlotinib, and investigate the relationship between baseline circulating tumor DNA (ctDNA) data and tumor dynamics. Data obtained for the analysis included (1) intensively sampled erlotinib concentrations from 29 patients from two previous pharmacokinetic (PK) studies, and (2) tumor sizes, ctDNA measurements, and sparsely sampled erlotinib concentrations from 18 patients from the START-TKI study. A two-compartment population PK model was first developed which well-described the PK data. The PK model was subsequently applied to investigate the exposure-tumor dynamics relationship. To characterize the tumor dynamics, models accounting for intra-tumor heterogeneity and acquired resistance with or without primary resistance were investigated. Eventually, the model assumed acquired resistance only resulted in an adequate fit. Additionally, models with or without exposure-dependent treatment effect were explored, and no significant exposure-response relationship for erlotinib was identified within the observed exposure range. Subsequently, the correlation of baseline ctDNA data on EGFR and TP53 variants with tumor dynamics' parameters was explored. The analysis indicated that higher baseline plasma EGFR mutation levels correlated with increased tumor growth rates, and the inclusion of ctDNA measurements improved model fit. This result suggests that quantitative ctDNA measurements at baseline have the potential to be a predictor of anticancer treatment response. The developed model can potentially be applied to design optimal treatment regimens that better overcome resistance.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; Erlotinib Hydrochloride/therapeutic use ; Erlotinib Hydrochloride/pharmacokinetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; ErbB Receptors/genetics ; Drug Resistance, Neoplasm/genetics ; Mutation
Chemical Substances	Erlotinib Hydrochloride (DA87705X9K) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2024-02-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2697010-7
ISSN	2163-8306 ; 2163-8306
ISSN (online)	2163-8306
ISSN	2163-8306
DOI	10.1002/psp4.13105
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Article ; Online: Feasibility of Community Pharmacist-Initiated and Point-of-Care CYP2C19 Genotype-Guided De-Escalation of Oral P2Y12 Inhibitors

Levens, Amar D. / den Haan, Melina C. / Jukema, J. Wouter / Heringa, Mette / van den Hout, Wilbert B. / Moes, Dirk Jan A. R. / Swen, Jesse J.

Genes (Basel). 2023 Feb. 25, v. 14, no. 3

2023

Abstract: Tailoring antiplatelet therapy based on CYP2C19 pharmacogenetic (PGx) testing can improve cardiovascular outcomes and potentially reduce healthcare costs in patients on a P2Y₁₂-inhibitor regime with prasugrel or ticagrelor. However, ubiquitous adoption— ... ...

Abstract	Tailoring antiplatelet therapy based on CYP2C19 pharmacogenetic (PGx) testing can improve cardiovascular outcomes and potentially reduce healthcare costs in patients on a P2Y₁₂-inhibitor regime with prasugrel or ticagrelor. However, ubiquitous adoption—particularly in an outpatient setting—remains limited. We conducted a proof-of-concept study to evaluate the feasibility of CYP2C19-guided de-escalation of prasugrel/ticagrelor to clopidogrel through point-of-care (POC) PGx testing in the community pharmacy. Multiple feasibility outcomes were assessed. Overall, 144 patients underwent CYP2C19 PGx testing in 27 community pharmacies. Successful test results were obtained in 142 patients (98.6%). De-escalation to clopidogrel occurred in 19 patients (20%) out of 95 (67%) eligible for therapy de-escalation, which was mainly due to PGx testing not being included in cardiology guidelines. Out of the 119 patients (84%) and 14 pharmacists (100%) surveyed, 109 patients (92%) found the community pharmacy a suitable location for PGx testing, and the majority of pharmacists (86%) thought it has added value. Net costs due to PGx testing were estimated at €43 per patient, which could be reduced by earlier testing and could turn into savings if de-escalation would double to 40%. Although the observed de-escalation rate was low, POC CYP2C19-guided de-escalation to clopidogrel appears feasible in a community pharmacy setting.
Keywords	patients ; point-of-care systems ; therapeutics
Language	English
Dates of publication	2023-0225
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article ; Online
ZDB-ID	2527218-4
ISSN	2073-4425
ISSN	2073-4425
DOI	10.3390/genes14030578
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: The Course of AαVal541 as a Proteinase 3 Specific Neo-Epitope after Alpha-1-Antitrypsin Augmentation in Severe Deficient Patients.

Schouten, Iris G M / Mumford, Richard A / Moes, Dirk Jan A R / Hiemstra, Pieter S / Stolk, Jan

International journal of molecular sciences

2021 Volume 22, Issue 15

Abstract: In alpha-1-antitrypsin deficiency (AATD), neutrophil serine proteases such as elastase and proteinase 3 (PR3) are insufficiently inhibited. A previous study in AATD patients showed a higher plasma level of the specific PR3-generated fibrinogen-derived ... ...

Abstract	In alpha-1-antitrypsin deficiency (AATD), neutrophil serine proteases such as elastase and proteinase 3 (PR3) are insufficiently inhibited. A previous study in AATD patients showed a higher plasma level of the specific PR3-generated fibrinogen-derived peptide AαVal541, compared with healthy controls. Here, we analyzed the course of AαVal541 plasma levels during 4 weeks after a single iv dose of 240 mg/kg AAT in ten patients with genotype Z/Rare or Rare/Rare. To this end, we developed an immunoassay to measure AαVal541 in plasma and applied population pharmacokinetic modeling for AAT. The median AαVal541 plasma level before treatment was 140.2 nM (IQR 51.5-234.8 nM)). In five patients who received AAT for the first time, AαVal541 levels decreased to 20.6 nM (IQR 5.8-88.9 nM), and in five patients who already had received multiple infusions before, it decreased to 26.2 nM (IQR 22.31-35.0 nM). In 9 of 10 patients, AαVal541 levels were reduced to the median level of healthy controls (21.4 nM; IQR 16.7-30.1 nM). At 7-14 days after treatment, AαVal541 levels started to increase again in all patients. Our results show that fibrinopeptide AαVal541 may serve as a biochemical footprint to assess the efficacy of in vivo inhibition of PR3 activity in patients receiving intravenous AAT augmentation therapy.
MeSH term(s)	Adult ; Epitopes/blood ; Female ; Humans ; Male ; Middle Aged ; Myeloblastin/antagonists & inhibitors ; Myeloblastin/blood ; Severity of Illness Index ; alpha 1-Antitrypsin/blood ; alpha 1-Antitrypsin Deficiency/blood ; alpha 1-Antitrypsin Deficiency/drug therapy
Chemical Substances	Epitopes ; SERPINA1 protein, human ; alpha 1-Antitrypsin ; Myeloblastin (EC 3.4.21.76)
Language	English
Publishing date	2021-07-27
Publishing country	Switzerland
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms22158031
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Article ; Online: Anti-cancer treatment schedule optimization based on tumor dynamics modelling incorporating evolving resistance.

Yin, Anyue / van Hasselt, Johan G C / Guchelaar, Henk-Jan / Friberg, Lena E / Moes, Dirk Jan A R

Scientific reports

2022 Volume 12, Issue 1, Page(s) 4206

Abstract: Quantitative characterization of evolving tumor resistance under targeted treatment could help identify novel treatment schedules, which may improve the outcome of anti-cancer treatment. In this study, a mathematical model which considers various clonal ... ...

Abstract	Quantitative characterization of evolving tumor resistance under targeted treatment could help identify novel treatment schedules, which may improve the outcome of anti-cancer treatment. In this study, a mathematical model which considers various clonal populations and evolving treatment resistance was developed. With parameter values fitted to the data or informed by literature data, the model could capture previously reported tumor burden dynamics and mutant KRAS levels in circulating tumor DNA (ctDNA) of patients with metastatic colorectal cancer treated with panitumumab. Treatment schedules, including a continuous schedule, intermittent schedules incorporating treatment holidays, and adaptive schedules guided by ctDNA measurements were evaluated using simulations. Compared with the continuous regimen, the simulated intermittent regimen which consisted of 8-week treatment and 4-week suspension prolonged median progression-free survival (PFS) of the simulated population from 36 to 44 weeks. The median time period in which the tumor size stayed below the baseline level (T
MeSH term(s)	Biomarkers, Tumor/genetics ; Circulating Tumor DNA/genetics ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; Humans ; Mutation ; Prospective Studies ; Treatment Outcome
Chemical Substances	Biomarkers, Tumor ; Circulating Tumor DNA
Language	English
Publishing date	2022-03-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-08012-7
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Article ; Online: Publisher Correction: Anti-cancer treatment schedule optimization based on tumor dynamics modelling incorporating evolving resistance.

Yin, Anyue / van Hasselt, Johan G C / Guchelaar, Henk-Jan / Friberg, Lena E / Moes, Dirk Jan A R

Scientific reports

2022 Volume 12, Issue 1, Page(s) 4879

Language	English
Publishing date	2022-03-22
Publishing country	England
Document type	Published Erratum
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-09014-1
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Article ; Online: Application of machine learning to predict tacrolimus exposure in liver and kidney transplant patients given the MeltDose formulation.

Ponthier, Laure / Marquet, Pierre / Moes, Dirk Jan A R / Rostaing, Lionel / van Hoek, Bart / Monchaud, Caroline / Labriffe, Marc / Woillard, Jean Baptiste

European journal of clinical pharmacology

2022 Volume 79, Issue 2, Page(s) 311–319

Abstract: Purpose: Machine Learning (ML) algorithms represent an interesting alternative to maximum a posteriori Bayesian estimators (MAP-BE) for tacrolimus AUC estimation, but it is not known if training an ML model using a lower number of full pharmacokinetic ( ... ...

Abstract	Purpose: Machine Learning (ML) algorithms represent an interesting alternative to maximum a posteriori Bayesian estimators (MAP-BE) for tacrolimus AUC estimation, but it is not known if training an ML model using a lower number of full pharmacokinetic (PK) profiles (= "true" reference AUC) provides better performances than using a larger dataset of less accurate AUC estimates. The objectives of this study were: to develop and benchmark ML algorithms trained using full PK profiles to estimate MeltDose Methods: Data from liver (n = 113) and kidney (n = 97) transplant recipients involved in MeltDose-tacrolimus PK studies were used for the training and evaluation of ML algorithms. "True" AUC0-24 h was calculated for each patient using the trapezoidal rule on the full PK profile. ML algorithms were trained to estimate tacrolimus true AUC using 2 or 3 blood concentrations. Performances were evaluated in 2 external sets of 16 (renal) and 48 (liver) transplant patients. Results: Best estimation performances were obtained with the MARS algorithm and the following limited sampling strategies (LSS): predose (0), 8, and 12 h post-dose (rMPE = - 1.28%, rRMSE = 7.57%), or 0 and 12 h (rMPE = - 1.9%, rRMSE = 10.06%). In the external dataset, the performances of the final ML algorithms based on two samples in kidney (rMPE = - 3.1%, rRMSE = 11.1%) or liver transplant recipients (rMPE = - 3.4%, rRMSE = 9.86%) were as good as or better than those of MAP-BEs based on three time points. Conclusion: The MARS ML models developed using "true" MeltDose
MeSH term(s)	Humans ; Tacrolimus/pharmacokinetics ; Immunosuppressive Agents/pharmacokinetics ; Kidney Transplantation ; Bayes Theorem ; Area Under Curve ; Liver
Chemical Substances	Tacrolimus (WM0HAQ4WNM) ; Immunosuppressive Agents
Language	English
Publishing date	2022-12-24
Publishing country	Germany
Document type	Journal Article
ZDB-ID	121960-1
ISSN	1432-1041 ; 0031-6970
ISSN (online)	1432-1041
ISSN	0031-6970
DOI	10.1007/s00228-022-03445-5
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Article ; Online: Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology.

Alsoud, Dahham / Moes, Dirk Jan A R / Wang, Zhigang / Soenen, Rani / Layegh, Zohra / Barclay, Murray / Mizuno, Tomoyuki / Minichmayr, Iris K / Keizer, Ron J / Wicha, Sebastian G / Wolbink, Gertjan / Lambert, Jo / Vermeire, Séverine / de Vries, Annick / Papamichael, Konstantinos / Padullés-Zamora, Núria / Dreesen, Erwin

Therapeutic drug monitoring

2024

Abstract: Background: Infliximab, an anti-tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on ... ...

Abstract	Background: Infliximab, an anti-tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on therapeutic drug monitoring (TDM) of infliximab in patients with IMIDs. It provides a practical guide on implementing TDM in current clinical practices and outlines priority areas for future research. Methods: The endorsing TDM of Biologics and Pharmacometrics Committees of the International Association of TDM and Clinical Toxicology collaborated to create this position statement. Results: Accumulating data support the evidence for TDM of infliximab in the treatment of inflammatory bowel diseases, with limited investigation in other IMIDs. A universal approach to TDM may not fully realize the benefits of improving therapeutic outcomes. Patients at risk for increased infliximab clearance, particularly with a proactive strategy, stand to gain the most from TDM. Personalized exposure targets based on therapeutic goals, patient phenotype, and infliximab administration route are recommended. Rapid assays and home sampling strategies offer flexibility for point-of-care TDM. Ongoing studies on model-informed precision dosing in inflammatory bowel disease will help assess the additional value of precision dosing software tools. Patient education and empowerment, and electronic health record-integrated TDM solutions will facilitate routine TDM implementation. Although optimization of therapeutic effectiveness is a primary focus, the cost-reducing potential of TDM also merits consideration. Conclusions: Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.
Language	English
Publishing date	2024-04-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	424443-6
ISSN	1536-3694 ; 0163-4356
ISSN (online)	1536-3694
ISSN	0163-4356
DOI	10.1097/FTD.0000000000001204
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Article ; Online: Unraveling the complexity of therapeutic drug monitoring for monoclonal antibody therapies to individualize dose in oncology.

Chatelut, Etienne / Hendrikx, Jeroen J M A / Martin, Jennifer / Ciccolini, Joseph / Moes, Dirk Jan A R

Pharmacology research & perspectives

2020 Volume 9, Issue 2, Page(s) e00757

Abstract: Monoclonal antibodies (Mabs) have become key drugs in cancer treatment, either as targeted therapies or more recently as immune checkpoint inhibitors (ICIs). The fact that only some patients benefit from these drugs poses the usual question in the field ... ...

Abstract	Monoclonal antibodies (Mabs) have become key drugs in cancer treatment, either as targeted therapies or more recently as immune checkpoint inhibitors (ICIs). The fact that only some patients benefit from these drugs poses the usual question in the field of onco-hematology: that of the benefit of individual dosing and the potential of therapeutic drug monitoring (TDM) to carry out this individualization. However, Mabs present unique pharmacological characteristics for TDM, and the pharmacokinetic-pharmacodynamic relationship observed should be interpreted differently than that observed for conventional drugs and small molecules. This pharmacology practice review has been summarized from a public debate between the authors at the International TDM and Clinical Toxicology meeting in Banff, 2020, regarding the potential roles of TDM in the Mab/ICI setting.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/pharmacokinetics ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/pharmacokinetics ; Dose-Response Relationship, Drug ; Drug Monitoring/methods ; Humans ; Immune Checkpoint Inhibitors/administration & dosage ; Immune Checkpoint Inhibitors/pharmacokinetics ; Medical Oncology/methods ; Molecular Targeted Therapy/methods ; Neoplasms/blood ; Neoplasms/drug therapy ; Neoplasms/immunology
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents, Immunological ; Immune Checkpoint Inhibitors
Language	English
Publishing date	2020-11-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2740389-0
ISSN	2052-1707 ; 2052-1707
ISSN (online)	2052-1707
ISSN	2052-1707
DOI	10.1002/prp2.757
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