Short-term intensified enteric-coated mycophenolate sodium (EC-MPS) dosing may facilitate steroid avoidance (SA) after kidney transplantation.

Methods. De novo kidney transplant recipients at low immunological risk (PRA ≤20%, cold ischemia time ≤36 hours) were randomized in a 6-month, multicenter, open-label trial to SA or maintenance steroids, all with intensified EC-MPS (2160mg/day to week 6, 1440mg/day thereafter), cyclosporine and IL-2RA induction. At month 6, patients who completed the study on-treatment could enter a further 30-month observational study.

Results. Of the 131/166 patients (78.9%; 70 SA, 61 controls) who completed the 6-month study on-treatment and were eligible for analysis in the follow-up study, 126 completed the 36-month study visit (68 SA, 58 controls). By month 36, 32.4% of SA patients and 51.7% of controls were receiving steroids. At the same time, the proportion of patients receiving cyclosporine plus EC-MPS was 83.6% in the SA group vs 70.2% of controls. The primary endpoint of treatment failure (biopsy-proven acute rejection [BPAR], graft loss, death or loss to follow-up) occurred in 21.4% (15/70) SA patients vs 16.4% (10/61) controls (p=0.46) by month 36. The incidence of BPAR was 20.0% and 11.5%, respectively (p=0.19), with all episodes graded IA or IB except for grade IIA in 1 SA and 3 control patients. Graft and patient survival were similar between groups. Mean creatinine clearance (MDRD4) was similar at month 36 (SA 50±19mL/min/1.73m², controls 55±20mL/min/1.73m², p=0.10). From month 6 to 36, the incidence of adverse events with a suspected relation to steroids was 22.9% with SA vs 37.1% controls (p=0.06) (infections 17.1% vs 16.1% [no CMV infection], dyslipidemia 2.9% vs 6.5%, diabetes 2.9% vs 4.8%, gastrointestinal complications 0.0% vs 4.8% and proteinuria 0% vs 1.6%).

Conclusions. Steroid avoidance is possible with early intensified EC-MPS dosing, calcineurin inhibition and IL-2RA induction in low-risk kidney transplant recipients without compromising efficacy at 3 years post-transplant, with a numerical reduction in steroid-related adverse events.

Kamar, N.: Grant/Research Support, Novartis (Myfortic), Speaker’s Bureau, Novartis (Myfortic), Other, Novartis (Myfortic), Consultant. Le Meur, Y.: Grant/Research Support, Novartis, Speaker’s Bureau, Novartis. Choukroun, G.: Grant/Research Support, Novartis. Legendre, C.: Speaker’s Bureau, Roche, Novartis, Astellas, Alexion. Merville, P.: Grant/Research Support, Novartis, Speaker’s Bureau, Novartis, BMS, Astellas. QuÉrÉ, S.: Employee, Novartis. LÉcuyer, A.: Employee, Novartis. Di Giambattista, F.: Employee, Novartis.

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