Journal Article

Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients

Tönshoff, Burkhard, Brunkhorst, Lena Caroline, Fichtner, Alexander, Pape, Lars, Höcker, Britta, Zapf, Antonia, Krupka, Kai, Bald, Martin, Burmeister, Greta, Ahlenstiel-Grunow, Thurid

2015

Overview

Data on the efficacy and safety of everolimus in pediatric renal transplantation compared to other immunosuppressive regimens are scarce. 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. Corticosteroids were withdrawn in 83% in the everolimus vs. 39% in the control group (p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). 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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adolescent / Anti-Inflammatory Agents, Non-Steroidal - administration & dosage / Anti-Inflammatory Agents, Non-Steroidal - adverse effects / Anti-Inflammatory Agents, Non-Steroidal - therapeutic use / Antibodies / Biomarkers / Biopsy / Calcineurin / Child / Child, Preschool / Children / Children & youth / Cohort Studies / Corticoids / Corticosteroids / Cyclosporins / Cytomegalovirus / Drug Therapy, Combination / Epidermal growth factor receptors / Everolimus - administration & dosage / Everolimus - adverse effects / Female / Graft rejection / Graft Rejection - drug therapy / Graft Rejection - immunology / Graft Survival - drug effects / Graft Survival - immunology / Health risk assessment / Histocompatibility antigen HLA / HLA Antigens - immunology / Hospitalization / Hospitals / Humans / Hyperlipidemia / Hypertension / Immunosuppressive agents / Immunosuppressive Agents - administration & dosage / Immunosuppressive Agents - adverse effects / Immunosuppressive Agents - therapeutic use / Inhibitor drugs / Isoantibodies - immunology / Kidney Function Tests / Kidney transplantation / Kidney Transplantation - adverse effects / Male / Medical schools / Mycophenolate mofetil / Mycophenolic acid / Mycophenolic Acid - administration & dosage / Mycophenolic Acid - adverse effects / Mycophenolic Acid - analogs & derivatives / Mycophenolic Acid - therapeutic use / Nephrology / Opportunistic Infections - etiology / Patients / Pediatrics / Retrospective Studies / Safety / Systematic review / Tissue Donors / Transplant Recipients / Transplantation / Transplants & implants / Treatment Outcome