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Purpose: To provide long-term data following post-transplant corticosteroid withdrawal (CSW) versus corticosteroid continuation (CSC).
Methods: The Mycophenolic Acid Observational Renal Transplant (MORE) registry is a prospective, observational 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). Groups were similar except for panel reactive antibodies <30% (CSW 90%, CSC 77%; p<0.01) and living donors (CSW 46%, CSC 41%; p=0.09), rabbit ATG induction (CSW 62%, CSC 59%; p=0.02) and alemtuzumab induction (CSW 24%, CSC 55%; p<0.01). Tacrolimus trough levels were similar. Full recommended MPA dose (1.44g EC-MPS, 2.0g MMF) was administered in fewer CSW versus CSC patients at all timepoints (all p<0.01). In the CSC group, more patients received the full MPA dose with EC-MPS versus MMF at months 1 (p=0.05), 3 (p=0.03), 6 (p=0.03) and 12 (p=0.03); there were no differences within the CSW group. Biopsy-proven acute rejection (BPAR) was similar (CSW 10%, CSC 14%; p=0.12), graft survival was higher in CSW patients (97% versus CSC 94%; p=0.03) and patient survival was similar (CSW 96%, CSC 95%; p=0.65). Final mean serum creatinine was similar (CSW 1.6g/dL, CSC 1.5g/dL; p=0.38). Neutropenia (CSW 17%, CSC 11%; p=0.01) and leukopenia (CSW 61%, CSC 30%; p<0.01) were more frequent following CSW, with a trend to fewer infections (25% versus CSC 31%; p=0.06).
Conclusion: Improved four-year graft survival in CSW patients despite a similar rate of BPAR to CSC patients may be due to lower immunological risk and a trend to more living donors. CSW patients were more likely to receive lymphocyte-depleting induction, which may have accounted for the higher rate of hematological adverse events and lower use of full MPA dosing versus CSC patients.