Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial

Abstract

Both patient and allograft survival proved to be excellent in paediatric patients (98.4% and 90.3%) and adults (96.8% and 95.0%). The rates of biopsy-proven acute rejections (BPAR) and treated acute rejection episodes (ARE) were comparable between paediatric (12.9% and 17.7%) and adult patients (15.5% and 20.7%). Transplant function at 12 months post-transplant was similar in paediatric (67.8 ± 45.6 mL/min/1.73 m2;) and adult recipients (64.7 ± 23.3 mL/min/1.73 m2;). Children < 6 years (n = 10) exhibited a numerically higher frequency of leucocytopaenia (20%), diarrhoea (40%) and weight loss (10%) than older children (6-18 years; 5.8%, 28.8% and 1.9%) and adults (16.1%, 24.7% and 1.5%). On the whole, the percentage of patients who experienced adverse events causing interruption of MMF therapy were numerically lower in children (4.8%) than in adults (12.5%). Conclusions. The overall efficacy and tolerability of MMF appear to be comparable between paediatric and adult patients. Further studies are needed to validate these results.

Inosine monophosphate dehydrogenase activity in paediatrics: age-related regulation and response to mycophenolic acid

“…This observation is also consistent with data from clinical studies, which demonstrated comparable efficacy of MMF regarding the prevention of acute rejection episodes in paediatric renal transplant recipients [2,4]. Data from this and previous studies in paediatric [11] and adult renal transplant recipients [13] also show that IMPDH activity returns to baseline within 4-8 h of administration of MMF.…”

“…The overall efficacy and safety of MMF appear to be similar in paediatric and adult renal transplant recipients [3,4].…”

Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

“…The recommended MMF dosage in conjunction with tacrolimus or without a concurrent CNI is 900 mg/m 2 per d in two divided doses (92); however, recent data indicate that the recommended MMF dosage of 1200 mg/m 2 per d in conjunction with CsA leads to MPA underexposure early after transplantation in approximately 60% of patients, indicating a need for a higher initial MMF dosage for optimal immunosuppressive activity (14). For achieving adequate MPA exposure in the majority of patients, an initial MMF dosage of 1800 mg/m 2 per d in conjunction with CsA and 1200 mg/m 2 per d in conjunction with tacrolimus for the first 2 to 4 weeks after transplantation has been suggested (14,93).…”

Paediatric use of mycophenolate mofetil

“…A limitation, however, was that trough‐level data were not available for all patients who relapsed, with one child who had the lowest AUC relapsing several times. In a recent RCT, which analysed paediatric data separately, it was demonstrated that ‘overall efficacy and tolerability of MMF in paediatrics appear to be comparable with that in adults’[39].…”