Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN)
Introduction: Patient-Reported Outcomes (PRO) integrate a wide range of holistic dimensions that arenot captured within clinical outcomes. Particularly, from induction treatment to maintenance therapy, patient quality-of-life (QoL) of kidney transplant recipients have been sparsely investigated in i...
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Frontiers Media S.A.
2023-04-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1040584/full |
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| author | François R. Girardin François R. Girardin Anna Nicolet Oriol Bestard Carmen Lefaucheur Carmen Lefaucheur Klemens Budde Fabian Halleck Sophie Brouard Magali Giral Pierre-Antoine Gourraud Béatrice Horcholle Jean Villard Joachim Marti Alexandre Loupy Alexandre Loupy |
| author_facet | François R. Girardin François R. Girardin Anna Nicolet Oriol Bestard Carmen Lefaucheur Carmen Lefaucheur Klemens Budde Fabian Halleck Sophie Brouard Magali Giral Pierre-Antoine Gourraud Béatrice Horcholle Jean Villard Joachim Marti Alexandre Loupy Alexandre Loupy |
| author_sort | François R. Girardin |
| collection | DOAJ |
| description | Introduction: Patient-Reported Outcomes (PRO) integrate a wide range of holistic dimensions that arenot captured within clinical outcomes. Particularly, from induction treatment to maintenance therapy, patient quality-of-life (QoL) of kidney transplant recipients have been sparsely investigated in international settings.Methods: In a prospective, multi-centric cohort study, including nine transplant centers in four countries, we explored the QoL during the year following transplantation using validated elicitation instruments (EQ-5D-3L index with VAS) in a population of kidney transplant patients receiving immunosuppressive therapies. Calcineurin inhibitors (tacrolimus and ciclosporin), IMPD inhibitor (mycophenolate mofetil), and mTOR inhibitors (everolimus and sirolimus) were the standard-of-care (SOC) medications, together with tapering glucocorticoid therapy. We used EQ-5D and VAS data as QoL measures alongside descriptive statistics at inclusion, per country and hospital center. We computed the proportions of patients with different immunosuppressive therapy patterns, and using bivariate and multivariate analyses, assessed the variations of EQ-5D and VAS between baseline (i.e., inclusion Month 0) and follow up visits (Month 12).Results: Among 542 kidney transplant patients included and followed from November 2018 to June 2021, 491 filled at least one QoL questionnaire at least at baseline (Month 0). The majority of patients in all countries received tacrolimus and mycophenolate mofetil, ranging from 90.0% in Switzerland and Spain to 95.8% in Germany. At M12, a significant proportion of patients switched immunosuppressive drugs, with proportion varying from 20% in Germany to 40% in Spain and Switzerland. At visit M12, patients who kept SOC therapy had higher EQ-5D (by 8 percentage points, p < 0.05) and VAS (by 4 percentage points, p < 0.1) scores than switchers. VAS scores were generally lower than EQ-5D (mean 0.68 [0.5–0.8] vs. 0.85 [0.8–1]).Discussion: Although overall a positive trend in QoL was observed, the formal analyses did not show any significant improvements in EQ-5D scores or VAS. Only when the effect of a therapy use was separated from the effect of switching, the VAS score was significantly worse for switchers during the follow up period, irrespective of the therapy type. If adjusted for patient characteristics and medical history (e.g., gender, BMI, eGRF, history of diabetes), VAS and EQ-5D delivered sound PRO measures for QoL assessments during the year following renal transplantation. |
| first_indexed | 2024-04-09T15:43:56Z |
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| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-09T15:43:56Z |
| publishDate | 2023-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-2e6caf2f781240f581c2326e49931e5f2023-04-27T05:27:56ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-04-011410.3389/fphar.2023.10405841040584Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN)François R. Girardin0François R. Girardin1Anna Nicolet2Oriol Bestard3Carmen Lefaucheur4Carmen Lefaucheur5Klemens Budde6Fabian Halleck7Sophie Brouard8Magali Giral9Pierre-Antoine Gourraud10Béatrice Horcholle11Jean Villard12Joachim Marti13Alexandre Loupy14Alexandre Loupy15Division of Clinical Pharmacology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital, Faculty of Medicine, University of Lausanne, Lausanne, SwitzerlandDivision of Clinical Pharmacology and Toxicology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, SwitzerlandCenter for Primary Care and Public Health (UniSanté), University of Lausanne, Lausanne, SwitzerlandDepartment of Nephrology and Kidney Transplantation, Vall d’Hebron Hospital Universitari, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, SpainKidney Transplant Department, Saint Louis Hospital, Unité de Recherche Clinique, Assistance Publique-Hôpitaux de Paris, Paris, FranceParis Translational Research Center for Organ Transplantation, Institut National de la Santé et de la Recherche Médicale UMR-S970, Université de Paris, Paris, FranceDepartment of Nephrology and Intensive Care, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, GermanyDepartment of Nephrology and Intensive Care, Charité Virchow Clinic, University Hospital, Berlin, GermanyNantes Université, INSERM, CRT2I—Center for Research in Transplantation and Translational Immunology, Nantes, FranceNantes Université, INSERM, CRT2I—Center for Research in Transplantation and Translational Immunology, Nantes, FranceNantes Université, INSERM, CRT2I—Center for Research in Transplantation and Translational Immunology, Nantes, FranceKidney Transplant Department, Saint Louis Hospital, Unité de Recherche Clinique, Assistance Publique-Hôpitaux de Paris, Paris, France0Transplantation Immunology Unit, National Reference Laboratory for Histocompatibility, Geneva University Hospitals and University of Geneva, Geneva, SwitzerlandCenter for Primary Care and Public Health (UniSanté), University of Lausanne, Lausanne, SwitzerlandParis Translational Research Center for Organ Transplantation, Institut National de la Santé et de la Recherche Médicale UMR-S970, Université de Paris, Paris, France1Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, FranceIntroduction: Patient-Reported Outcomes (PRO) integrate a wide range of holistic dimensions that arenot captured within clinical outcomes. Particularly, from induction treatment to maintenance therapy, patient quality-of-life (QoL) of kidney transplant recipients have been sparsely investigated in international settings.Methods: In a prospective, multi-centric cohort study, including nine transplant centers in four countries, we explored the QoL during the year following transplantation using validated elicitation instruments (EQ-5D-3L index with VAS) in a population of kidney transplant patients receiving immunosuppressive therapies. Calcineurin inhibitors (tacrolimus and ciclosporin), IMPD inhibitor (mycophenolate mofetil), and mTOR inhibitors (everolimus and sirolimus) were the standard-of-care (SOC) medications, together with tapering glucocorticoid therapy. We used EQ-5D and VAS data as QoL measures alongside descriptive statistics at inclusion, per country and hospital center. We computed the proportions of patients with different immunosuppressive therapy patterns, and using bivariate and multivariate analyses, assessed the variations of EQ-5D and VAS between baseline (i.e., inclusion Month 0) and follow up visits (Month 12).Results: Among 542 kidney transplant patients included and followed from November 2018 to June 2021, 491 filled at least one QoL questionnaire at least at baseline (Month 0). The majority of patients in all countries received tacrolimus and mycophenolate mofetil, ranging from 90.0% in Switzerland and Spain to 95.8% in Germany. At M12, a significant proportion of patients switched immunosuppressive drugs, with proportion varying from 20% in Germany to 40% in Spain and Switzerland. At visit M12, patients who kept SOC therapy had higher EQ-5D (by 8 percentage points, p < 0.05) and VAS (by 4 percentage points, p < 0.1) scores than switchers. VAS scores were generally lower than EQ-5D (mean 0.68 [0.5–0.8] vs. 0.85 [0.8–1]).Discussion: Although overall a positive trend in QoL was observed, the formal analyses did not show any significant improvements in EQ-5D scores or VAS. Only when the effect of a therapy use was separated from the effect of switching, the VAS score was significantly worse for switchers during the follow up period, irrespective of the therapy type. If adjusted for patient characteristics and medical history (e.g., gender, BMI, eGRF, history of diabetes), VAS and EQ-5D delivered sound PRO measures for QoL assessments during the year following renal transplantation.https://www.frontiersin.org/articles/10.3389/fphar.2023.1040584/fullimmunosuppressantkidney transplant patientquality of lifePROMSVAS (analog visual scale)EQ5D 3L |
| spellingShingle | François R. Girardin François R. Girardin Anna Nicolet Oriol Bestard Carmen Lefaucheur Carmen Lefaucheur Klemens Budde Fabian Halleck Sophie Brouard Magali Giral Pierre-Antoine Gourraud Béatrice Horcholle Jean Villard Joachim Marti Alexandre Loupy Alexandre Loupy Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) Frontiers in Pharmacology immunosuppressant kidney transplant patient quality of life PROMS VAS (analog visual scale) EQ5D 3L |
| title | Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) |
| title_full | Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) |
| title_fullStr | Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) |
| title_full_unstemmed | Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) |
| title_short | Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN) |
| title_sort | immunosuppressant drugs and quality of life outcomes in kidney transplant recipients an international cohort study eu train |
| topic | immunosuppressant kidney transplant patient quality of life PROMS VAS (analog visual scale) EQ5D 3L |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1040584/full |
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