Maral Baghai Arassi , Manuel Feißt , Kai Krupka , Atif Awan , Elisa Benetti , Ali Düzova , Isabella Guzzo , Jon Jin Kim , Birgitta Kranz , Mieczysław Litwin , Jun Oh , Anja Büscher , Lars Pape , Licia Peruzzi , Mohan Shenoy , Sara Testa , Lutz T. Weber , Jakub Zieg , Britta Höcker , Alexander Fichtner , Burkhard Tönshoff
{"title":"CERTAIN 登记处小儿肾移植受者排斥率、感染和他克莫司暴露的年龄差异","authors":"Maral Baghai Arassi , Manuel Feißt , Kai Krupka , Atif Awan , Elisa Benetti , Ali Düzova , Isabella Guzzo , Jon Jin Kim , Birgitta Kranz , Mieczysław Litwin , Jun Oh , Anja Büscher , Lars Pape , Licia Peruzzi , Mohan Shenoy , Sara Testa , Lutz T. Weber , Jakub Zieg , Britta Höcker , Alexander Fichtner , Burkhard Tönshoff","doi":"10.1016/j.ekir.2024.08.025","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Data on age-related differences in rejection rates, infectious episodes, and tacrolimus exposure in pediatric kidney transplant recipients (pKTRs) on a tacrolimus-based immunosuppressive regimen are scarce.</div></div><div><h3>Methods</h3><div>We performed a large-scale analysis of 802 pKTRs from the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN) registry from 40 centers in 14 countries. The inclusion criteria were a tacrolimus-based immunosuppressive regimen and at least 2 years of follow-up. The patient population was divided into 3 age groups (infants and young children aged <6 years, school-aged children 6–12 years, and adolescents aged >12 years) to assess age-related differences in outcome.</div></div><div><h3>Results</h3><div>Median follow-up was 48 months (interquartile range [IQR], 36–72). Within the first 2 years posttransplant, infants, and young children had a significantly higher incidence of infections (80.6% vs. 55.0% in adolescents, <em>P</em> < 0.001) and a significantly higher number of cumulative hospital days (median 13 days vs. 7 days in adolescents, <em>P</em> < 0.001). Adolescents had a significantly higher rate of biopsy-proven acute rejection episodes in the first-year posttransplant (21.7%) than infants and young children (12.6%, <em>P</em> = 0.007). Infants and young children had significantly lower tacrolimus trough levels, lower tacrolimus concentration-to-dose (C/D) ratios as an approximation for higher tacrolimus clearance, and higher tacrolimus interpatient variability (TacIPV) (all <em>P</em> < 0.01) than adolescents.</div></div><div><h3>Conclusion</h3><div>This is the largest study to date in European pKTRs on a tacrolimus-based immunosuppressive regimen, and it shows important age-related differences in rejection rates, infection episodes, as well as tacrolimus exposure and clearance. This data suggests that immunosuppressive therapy in pKTRs should be tailored and personalized according to the age-specific risk profiles of this heterogeneous patient population. The data may serve as a benchmark for future studies with novel immunosuppressive drugs.</div></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Age-Related Differences in Rejection Rates, Infections, and Tacrolimus Exposure in Pediatric Kidney Transplant Recipients in the CERTAIN Registry\",\"authors\":\"Maral Baghai Arassi , Manuel Feißt , Kai Krupka , Atif Awan , Elisa Benetti , Ali Düzova , Isabella Guzzo , Jon Jin Kim , Birgitta Kranz , Mieczysław Litwin , Jun Oh , Anja Büscher , Lars Pape , Licia Peruzzi , Mohan Shenoy , Sara Testa , Lutz T. Weber , Jakub Zieg , Britta Höcker , Alexander Fichtner , Burkhard Tönshoff\",\"doi\":\"10.1016/j.ekir.2024.08.025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>Data on age-related differences in rejection rates, infectious episodes, and tacrolimus exposure in pediatric kidney transplant recipients (pKTRs) on a tacrolimus-based immunosuppressive regimen are scarce.</div></div><div><h3>Methods</h3><div>We performed a large-scale analysis of 802 pKTRs from the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN) registry from 40 centers in 14 countries. The inclusion criteria were a tacrolimus-based immunosuppressive regimen and at least 2 years of follow-up. The patient population was divided into 3 age groups (infants and young children aged <6 years, school-aged children 6–12 years, and adolescents aged >12 years) to assess age-related differences in outcome.</div></div><div><h3>Results</h3><div>Median follow-up was 48 months (interquartile range [IQR], 36–72). Within the first 2 years posttransplant, infants, and young children had a significantly higher incidence of infections (80.6% vs. 55.0% in adolescents, <em>P</em> < 0.001) and a significantly higher number of cumulative hospital days (median 13 days vs. 7 days in adolescents, <em>P</em> < 0.001). Adolescents had a significantly higher rate of biopsy-proven acute rejection episodes in the first-year posttransplant (21.7%) than infants and young children (12.6%, <em>P</em> = 0.007). Infants and young children had significantly lower tacrolimus trough levels, lower tacrolimus concentration-to-dose (C/D) ratios as an approximation for higher tacrolimus clearance, and higher tacrolimus interpatient variability (TacIPV) (all <em>P</em> < 0.01) than adolescents.</div></div><div><h3>Conclusion</h3><div>This is the largest study to date in European pKTRs on a tacrolimus-based immunosuppressive regimen, and it shows important age-related differences in rejection rates, infection episodes, as well as tacrolimus exposure and clearance. This data suggests that immunosuppressive therapy in pKTRs should be tailored and personalized according to the age-specific risk profiles of this heterogeneous patient population. 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Age-Related Differences in Rejection Rates, Infections, and Tacrolimus Exposure in Pediatric Kidney Transplant Recipients in the CERTAIN Registry
Introduction
Data on age-related differences in rejection rates, infectious episodes, and tacrolimus exposure in pediatric kidney transplant recipients (pKTRs) on a tacrolimus-based immunosuppressive regimen are scarce.
Methods
We performed a large-scale analysis of 802 pKTRs from the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN) registry from 40 centers in 14 countries. The inclusion criteria were a tacrolimus-based immunosuppressive regimen and at least 2 years of follow-up. The patient population was divided into 3 age groups (infants and young children aged <6 years, school-aged children 6–12 years, and adolescents aged >12 years) to assess age-related differences in outcome.
Results
Median follow-up was 48 months (interquartile range [IQR], 36–72). Within the first 2 years posttransplant, infants, and young children had a significantly higher incidence of infections (80.6% vs. 55.0% in adolescents, P < 0.001) and a significantly higher number of cumulative hospital days (median 13 days vs. 7 days in adolescents, P < 0.001). Adolescents had a significantly higher rate of biopsy-proven acute rejection episodes in the first-year posttransplant (21.7%) than infants and young children (12.6%, P = 0.007). Infants and young children had significantly lower tacrolimus trough levels, lower tacrolimus concentration-to-dose (C/D) ratios as an approximation for higher tacrolimus clearance, and higher tacrolimus interpatient variability (TacIPV) (all P < 0.01) than adolescents.
Conclusion
This is the largest study to date in European pKTRs on a tacrolimus-based immunosuppressive regimen, and it shows important age-related differences in rejection rates, infection episodes, as well as tacrolimus exposure and clearance. This data suggests that immunosuppressive therapy in pKTRs should be tailored and personalized according to the age-specific risk profiles of this heterogeneous patient population. The data may serve as a benchmark for future studies with novel immunosuppressive drugs.
期刊介绍：
Kidney International Reports, an official journal of the International Society of Nephrology, is a peer-reviewed, open access journal devoted to the publication of leading research and developments related to kidney disease. With the primary aim of contributing to improved care of patients with kidney disease, the journal will publish original clinical and select translational articles and educational content related to the pathogenesis, evaluation and management of acute and chronic kidney disease, end stage renal disease (including transplantation), acid-base, fluid and electrolyte disturbances and hypertension. Of particular interest are submissions related to clinical trials, epidemiology, systematic reviews (including meta-analyses) and outcomes research. The journal will also provide a platform for wider dissemination of national and regional guidelines as well as consensus meeting reports.
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