title: Efficacy and Safety of an Everolimus- vs. a Mycophenolate Mofetil-Based Regimen in Pediatric Renal Transplant Recipients.
abstract: BACKGROUND
  Data on the efficacy and safety of everolimus in pediatric renal transplantation compared to other immunosuppressive regimens are scarce.
  
  
  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  Corticosteroids were withdrawn in 83% in the everolimus vs. 39% in the control group (p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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.
authors.forename: Lena Caroline
authors.initials: LC
authors.lastname: Brunkhorst
authors.affiliation: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Fichtner
authors.affiliation: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Britta
authors.initials: B
authors.lastname: Höcker
authors.affiliation: Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany; Department of Visceral and Transplant Surgery, University Hospital of Schleswig-Holstein, Kiel, Germany.
authors.forename: Greta
authors.initials: G
authors.lastname: Burmeister
authors.affiliation: Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.
authors.forename: Thurid
authors.initials: T
authors.lastname: Ahlenstiel-Grunow
authors.affiliation: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Kai
authors.initials: K
authors.lastname: Krupka
authors.affiliation: Department of Pediatric Nephrology, Olgahospital, Stuttgart, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Bald
authors.affiliation: Department of Biostatistics, University Clinic of Göttingen, Göttingen, Germany.
authors.forename: Antonia
authors.initials: A
authors.lastname: Zapf
authors.affiliation: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Tönshoff
authors.affiliation: Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Pape
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D000068338:Everolimus / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy / Q000276:immunology; D006085:Graft Survival / Q000187:drug effects / Q000276:immunology; D006680:HLA Antigens / Q000276:immunology; D006760:Hospitalization; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007518:Isoantibodies / Q000276:immunology; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009894:Opportunistic Infections / Q000209:etiology; D012189:Retrospective Studies; D014019:Tissue Donors; D066027:Transplant Recipients; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D015415:Biomarkers; D006680:HLA Antigens; D007166:Immunosuppressive Agents; D007518:Isoantibodies; D000068338:Everolimus; D009173:Mycophenolic Acid