Abstract
In a six-month, multicenter, open-label trial, de novo kidney transplant recipients at low immunological risk were randomized to steroid avoidance or steroid withdrawal with IL-2 receptor antibody (IL-2RA) induction, enteric-coated mycophenolate sodium (EC-MPS: 2160 mg/day to week 6, 1440 mg/day thereafter), and cyclosporine. Results from a 30-month observational follow-up study are presented. Of 166 patients who completed the core study on treatment, 131 entered the follow-up study (70 steroid avoidance, 61 steroid withdrawal). The primary efficacy endpoint of treatment failure (clinical biopsy-proven acute rejection (BPAR) graft loss, death, or loss to follow-up) occurred in 21.4% (95% CI 11.8–31.0%) of steroid avoidance patients and 16.4% (95% CI 7.1–25.7%) of steroid withdrawal patients by month 36 (P = 0.46). BPAR had occurred in 20.0% and 11.5%, respectively (P = 0.19). The incidence of adverse events with a suspected relation to steroids during months 6–36 was 22.9% versus 37.1% (P = 0.062). By month 36, 32.4% and 51.7% of patients in the steroid avoidance and steroid withdrawal groups, respectively, were receiving oral steroids. In conclusion, IL-2RA induction with early intensified EC-MPS dosing and CNI therapy in de novo kidney transplant patients at low immunological risk may achieve similar three-year efficacy regardless of whether oral steroids are withheld for at least three months.
Highlights
Steroid avoidance is frequently attempted in de novo kidney transplant recipients at low immunological risk [1] to prevent the long-term complications associated with maintenance steroid therapy
The randomized, multicenter DOMINOS study compared a regimen in which patients were given no oral steroids versus a regimen of standard oral steroids for at least three months, followed by steroid withdrawal where appropriate, in de novo low-risk kidney transplant patients receiving an induction by interleukin 2 receptor (IL-2R) inhibitor, cyclosporine (CsA), and early intensified enteric-coated mycophenolate sodium (EC-MPS) dosing to week 6 after transplant [9]
One additional patient who had been randomized to the steroid withdrawal group was included inadvertently despite not receiving EC-MPS and CsA at completion of the DOMINOS study and was included only in the safety analyses
Summary
Steroid avoidance is frequently attempted in de novo kidney transplant recipients at low immunological risk [1] to prevent the long-term complications associated with maintenance steroid therapy. The randomized, multicenter DOMINOS study compared a regimen in which patients were given no oral steroids versus a regimen of standard oral steroids for at least three months, followed by steroid withdrawal where appropriate, in de novo low-risk kidney transplant patients receiving an induction by interleukin 2 receptor (IL-2R) inhibitor, cyclosporine (CsA), and early intensified enteric-coated mycophenolate sodium (EC-MPS) dosing to week 6 after transplant [9]. The major randomized trials of steroid avoidance in patients receiving CNI therapy with MPA have followed patients to only six [4], 12 [2, 3, 6] or 24 months [5] after transplant and have reported mixed results concerning the effect of a steroid avoidance regimen on metabolic complications. Longer-term data on the efficacy and safety implications of a steroid avoidance MPA-based immunosuppressive strategy in this setting are of key clinical interest
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