Prospective, long-term data on efficacy and safety outcomes following CSW versus corticosteroid continuation (CSC) in kidney transplant patients during routine clinical practice are largely unavailable.

Methods: MORE is a prospective, observational, 4-year study of de novo adult kidney transplant patients receiving mycophenolic acid (MPA) according to local practice at 40 US centers. CSW was defined as steroid withdrawal by month 3 post-transplant.

Results: 872 tacrolimus-treated patients were analyzed (CSW 363, CSC 509). CSW patients more frequently had panel reactive antibodies <30% (89.9% vs 77.0% for CSC, p<0.01) with a trend to more living donors (46.3% vs 40.7%, p=0.09). Induction with Thymoglobulin (62.3% vs 58.6%, p=0.02) or alemtuzumab (23.7% vs 4.7%, p<0.01) was more widely used with CSW than CSC. Tacrolimus trough levels were similar. For CSW vs CSC patients at 4 years post-transplant, biopsy-proven acute rejection (BPAR) was similar (10.1% vs 14.3%; log rank p=0.12), graft survival was higher (96.9% vs 93.7%; log rank p=0.03) and patient survival was similar (95.6% vs 95.0%; log rank p=0.65). Cox regression analysis confirmed the univariate findings for CSW vs CSC patients: the risk of BPAR was not significantly different (hazard ratio 0.76; 95% CI 0.47, 1.22; p=0.27), risk of graft loss was significantly lower (0.36; 0.13, 0.87; p=0.03) and risk of death was similar (0.87; 0.33, 2.15; p=0.76). Mean estimated GFR (eGFR, CKD-EPI formula) was CSW 59.5 vs CSC 57.5mL/min/1.73m² (p=0.84) at 1 year and 57.7 vs 58.1mL/min/1.73m² (p=0.44) at 3 years. Hematological adverse events were more frequent in the CSW group (64.2% vs 34.2%, p<0.01). Infections occurred in 24.8% CSW patients vs 30.8% CSC patients (p=0.06). Other adverse events by organ system were similar between groups.

Conclusion: Results at 4 years post-transplant confirm a lower risk of graft loss for CSW patients in routine practice, possibly due to lower immunological risk and a trend to more living donors. In routine practice, increased use of lymphocyte-depleting induction when CSW is planned may account for the observed increase of hematological adverse events in CSW patients.

Ueda, K.: Grant/Research Support, Novartis, Other, Novartis, Consultant. Wiland, A.: Employee, Novartis. McCague, K.: Employee, Novartis. Ram Peddi, V.: Grant/Research Support, Novartis, Quark, Pfizer, Astellas, Chimerix, Speaker’s Bureau, Gentech, Novartis, Other, Novartis, Consultant, Genzyme, Consultant.

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