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.
To cite this abstract in AMA style:Thierry A, Mourad G, Büchler M, Kamar N, Villemain F, Heng A, Le Y, Choukroun G, Toupance O, Legendre C, Le P, Kessler M, Merville P, Moulin B, Quéré S, Lécuyer A, Di F, Touchard G. Three-Year Safety and Efficacy Outcomes in Kidney Transplant Patients Randomized to Steroid Avoidance or Maintenance Steroids with Early Intensified Dosing of Enteric-Coated Mycophenolate Sodium: The INFINITY Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/three-year-safety-and-efficacy-outcomes-in-kidney-transplant-patients-randomized-to-steroid-avoidance-or-maintenance-steroids-with-early-intensified-dosing-of-enteric-coated-mycophenolate-sodium-the/. Accessed September 23, 2017.
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