Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients
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Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients. / Brunkhorst, Lena Caroline; Fichtner, Alexander; Höcker, Britta; Burmeister, Greta; Ahlenstiel-Grunow, Thurid; Krupka, Kai; Bald, Martin; Zapf, Antonia; Tönshoff, Burkhard; Pape, Lars.
In: PLOS ONE, Vol. 10, No. 9, 2015, p. e0135439.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients
AU - Brunkhorst, Lena Caroline
AU - Fichtner, Alexander
AU - Höcker, Britta
AU - Burmeister, Greta
AU - Ahlenstiel-Grunow, Thurid
AU - Krupka, Kai
AU - Bald, Martin
AU - Zapf, Antonia
AU - Tönshoff, Burkhard
AU - Pape, Lars
PY - 2015
Y1 - 2015
N2 - INTRODUCTION: Data on the efficacy and safety of everolimus in pediatric renal transplantation compared to other immunosuppressive regimens are scarce.PATIENTS/METHODS: We therefore performed a multicenter, observational, matched cohort study over 4 years post-transplant in 35 patients on everolimus plus low-dose cyclosporine, who were matched (1:2) with a control group of 70 children receiving a standard-dose calcineurin-inhibitor- and mycophenolate mofetil-based regimen.RESULTS: Corticosteroids were withdrawn in 83% in the everolimus vs. 39% in the control group (p<0.001). Patient and graft survival were comparable. The rate of biopsy-proven acute rejection episodes Banff score ≥ IA during the first year post-transplant was 6% in the everolimus vs. 13% in the control group (p = 0.23). The rate of de novo donor-specific HLA antibodies (11% in everolimus, 18% in controls) was comparable (p = 0.55). At 4 years post-transplant, mean eGFR in the everolimus group was 56±33 ml/min per 1.73 m² vs. 63±22 ml/min per 1.73 m² in the control group (p = 0.14). Everolimus therapy was associated with less BK polyomavirus replication (3% vs. 17% in controls; p = 0.04), but with a higher percentage of arterial hypertension and more hyperlipidemia (p<0.001).CONCLUSION: In pediatric renal transplantation, an everolimus-based regimen with low-dose cyclosporine yields comparable four year results as a standard regimen, but with a different side effect profile.
AB - INTRODUCTION: Data on the efficacy and safety of everolimus in pediatric renal transplantation compared to other immunosuppressive regimens are scarce.PATIENTS/METHODS: We therefore performed a multicenter, observational, matched cohort study over 4 years post-transplant in 35 patients on everolimus plus low-dose cyclosporine, who were matched (1:2) with a control group of 70 children receiving a standard-dose calcineurin-inhibitor- and mycophenolate mofetil-based regimen.RESULTS: Corticosteroids were withdrawn in 83% in the everolimus vs. 39% in the control group (p<0.001). Patient and graft survival were comparable. The rate of biopsy-proven acute rejection episodes Banff score ≥ IA during the first year post-transplant was 6% in the everolimus vs. 13% in the control group (p = 0.23). The rate of de novo donor-specific HLA antibodies (11% in everolimus, 18% in controls) was comparable (p = 0.55). At 4 years post-transplant, mean eGFR in the everolimus group was 56±33 ml/min per 1.73 m² vs. 63±22 ml/min per 1.73 m² in the control group (p = 0.14). Everolimus therapy was associated with less BK polyomavirus replication (3% vs. 17% in controls; p = 0.04), but with a higher percentage of arterial hypertension and more hyperlipidemia (p<0.001).CONCLUSION: In pediatric renal transplantation, an everolimus-based regimen with low-dose cyclosporine yields comparable four year results as a standard regimen, but with a different side effect profile.
KW - Adolescent
KW - Anti-Inflammatory Agents, Non-Steroidal
KW - Biomarkers
KW - Child
KW - Child, Preschool
KW - Cohort Studies
KW - Drug Therapy, Combination
KW - Everolimus
KW - Female
KW - Graft Rejection
KW - Graft Survival
KW - HLA Antigens
KW - Hospitalization
KW - Humans
KW - Immunosuppressive Agents
KW - Isoantibodies
KW - Kidney Function Tests
KW - Kidney Transplantation
KW - Male
KW - Mycophenolic Acid
KW - Opportunistic Infections
KW - Retrospective Studies
KW - Tissue Donors
KW - Transplant Recipients
KW - Treatment Outcome
KW - Journal Article
KW - Multicenter Study
KW - Research Support, Non-U.S. Gov't
U2 - 10.1371/journal.pone.0135439
DO - 10.1371/journal.pone.0135439
M3 - SCORING: Journal article
C2 - 26407177
VL - 10
SP - e0135439
JO - PLOS ONE
JF - PLOS ONE
SN - 1932-6203
IS - 9
ER -