Goal-Oriented Monitoring of Cyclosporine Is Effective for Graft-versus-Host Disease Prevention after Hematopoietic Stem Cell Transplantation in Sickle Cell Disease and Thalassemia Major

Gauthier, Alexandra; Bleyzac, Nathalie; Garnier, Nathalie; Kébaïli, Kamila; Joly, Philippe; Goutagny, Marie-Pierre; Mollet, Isabelle; Goutelle, Sylvain; Rénard, C.; Bertrand, Yves

doi:10.1016/j.bbmt.2020.01.016

Cited by 3 publications

(4 citation statements)

References 37 publications

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“…The comparison of CsA concentrations in these studies is difficult because different CsA assays are used. C trough targets vary from 150 µg/L to more than 350 µg/L 19,20 …”

Section: Discussionmentioning

confidence: 99%

TRough versus AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in adult allogeneic stem cell recipients (TRAM study)

Kuijvenhoven

Wilhelm

Meijer

et al. 2021

European J of Haematology

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Objective To investigate the incidence and severity of adverse drug reactions of cyclosporine using AUC‐targeted therapeutic drug monitoring (TDM) compared to trough level (Ctrough)‐targeted TDM in adult allogeneic stem cell recipients. Methods Blind, monocenter, intervention study. Subjects were 1:1 randomized into either an AUC group or a Ctrough group. Adverse drug reactions were accessed two and four weeks after start of treatment. Results Forty patients were included, resulting in 15 evaluable subjects (AUC group) and 13 evaluable subjects (Ctrough group). Grade two/three toxicity was observed in 46% (Ctrough group) versus 60% of subjects (AUC group) (P = .463). There was no significant difference between two and four weeks after start of cyclosporine for nausea (P = .142 resp. P = .122), renal dysfunction (P = .464 resp. P = 1.000), and hypomagnesemia (P = 1.000 resp. P = .411). Subjects in the AUC group reached the therapeutic goal earlier (72,7% versus 43,0% at third sampling point, P = .332) and were within the target range more consistently. Conclusion This study showed no reduction in incidence and severity of cyclosporine‐induced toxicity with AUC‐ versus trough level‐targeted TDM. Although modeled dosing based on AUC led to faster optimal target attainment, this did not result in less toxicity in the early days after transplantation.

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“…The comparison of CsA concentrations in these studies is difficult because different CsA assays are used. C trough targets vary from 150 µg/L to more than 350 µg/L 19,20 …”

Section: Discussionmentioning

confidence: 99%

TRough versus AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in adult allogeneic stem cell recipients (TRAM study)

Kuijvenhoven

Wilhelm

Meijer

et al. 2021

European J of Haematology

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“…The retrospective aspect of the study did not allow us to assess outcomes per quality-adjusted life year, as recommended by the French National Authority for Health. 30 However, as we have previously published the clinical benefits of our CsA TDM, 16,20 it was difficult to perform a randomized prospective study for ethical reasons.…”

Section: Discussionmentioning

confidence: 99%

“…17,19 We recently published our strategy regarding the target exposure of CsA and the method of therapeutic drug monitoring (TDM) of CsA TBC, combined with Bayesian dose adjustment, in a large cohort of children who underwent transplantation for highrisk acute leukemia or hemoglobinopathies. 16,20 In addition to complications, HSCT costs must also be considered. Indeed, HSCT is a costly medical procedure, with costs varying between $80 000 and $140 000.…”

Section: Introductionmentioning

confidence: 99%

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Impact of a Bayesian Individualization of Cyclosporine Dosage Regimen for Children Undergoing Allogeneic Hematopoietic Cell Transplantation: A Cost-Effectiveness Analysis

Beyron

Ceraulo

Bertrand

et al. 2021

Therapeutic Drug Monitoring

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Background: Cyclosporine A (CsA) is the main drug used to prevent graft-versus-host disease in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). CsA therapeutic drug monitoring (TDM) has been performed for ages, with studies revealing clinical benefits, but failing to examine its economic impact. In this article, the main objective was to evaluate the economic impact of the CsA TDM strategy, based on a Bayesian approach, by assessing costs related to its clinical impact. Furthermore, TDM effectiveness was analyzed for pharmacokinetics and clinical outcomes.Methods: A cost-effective, nonrandomized, retrospective, singlecenter study compared 2 CsA monitoring and dose adaptation strategies in pediatric patients undergoing HSCT. From 2014 to 2016, CsA TDM was performed using a population pharmacokinetics model-coupled Bayesian approach by a pharmacist ["pharmacist-assisted individualization" (PAI)]. From 2017 to 2018, CsA TDM was performed by the clinician without a Bayesian approach (non-PAI group). HSCT costs were evaluated from the French National Insurance perspective. Economic and clinical outcomes were assessed by measuring incremental costeffectiveness ratios. Results:The study included 144 patients: 90 and 54 patients in PAI and non-PAI groups, respectively. Both groups were comparable for sociodemographic and clinical characteristics. The mean total cost per patient was significantly lower (P , 0.01) in the PAI group (€85,947) than in the non-PAI group (€100,435). Multivariate analysis revealed that TDM based on the Bayesian approach was a protective factor (odds ratio = 0.86) for severe acute graft-versus-host disease. We noted that pharmacist-based TDM was the dominant strategy. Bayesian method-based TDM allowed an increase in the percentage of target attainment at any period post-HSCT. Conclusions:CsA TDM with a Bayesian approach is a costeffective procedure, and highlighted clinical benefits encourage the development of new TDM strategies for HSCT.

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Recent results of hematopoietic stem cell transplantation for thalassemia with busulfan-based conditioning regimen in France: improved thalassemia free survival despite frequent mixed chimerism. A retrospective study from the Francophone Society of Stem Cell Transplantation and Cellular Therapy (SFGM-TC)

Rossi

Szepetowski

Yakouben

et al. 2023

Bone Marrow Transplant

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Goal-Oriented Monitoring of Cyclosporine Is Effective for Graft-versus-Host Disease Prevention after Hematopoietic Stem Cell Transplantation in Sickle Cell Disease and Thalassemia Major

Cited by 3 publications

References 37 publications

TRough versus AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in adult allogeneic stem cell recipients (TRAM study)

TRough versus AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in adult allogeneic stem cell recipients (TRAM study)

Impact of a Bayesian Individualization of Cyclosporine Dosage Regimen for Children Undergoing Allogeneic Hematopoietic Cell Transplantation: A Cost-Effectiveness Analysis

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