Steroid Avoidance With Low-Dose Tacrolimus is Safe and Effective in the Long-Term for Kidney Transplant Recipients

In our previous multicenter, open-label, randomized controlled trial (RCT), the SAILOR study, we reported good feasibility, safety, and efficacy of steroid avoidance (SA) at 2 years in immunologically low-risk kidney transplant recipients. A total of 222 participants were randomized to either antithymocyte globulin (ATG) induction + low-dose tacrolimus + mycophenolate mofetil (MMF) or basiliximab induction + low-dose tacrolimus + MMF + prednisolone. Long-term results are needed to confirm the extended safety and efficacy of the SA protocol beyond the short- to medium-term follow-up seen in current reports using low-dose tacrolimus.

In the SAILOR follow-up observational study, we collected clinical data of 215 participants of the original SAILOR trial at 1, 2, 5 years, and at the last follow-up.

The mean follow-up time postrandomization was 7.3 years. Death-censored graft survival (91.8 vs. 93.1%, P = 0.88), patient survival (88 vs. 93%, P = 0.32), cumulative incidence of biopsy-proven rejection (19.8% vs. 16.3%, P = 0.6), and kidney function (estimated glomerular filtration rate [eGFR]: 50.8 vs. 54 ml/min per 1.73 m², P = 0.27) were similar in the 2 arms. Cumulative incidence of posttransplantation diabetes mellitus in per-protocol population was significantly lower in the steroid-avoidance arm. Serious infections requiring hospitalization, and malignancies did not differ significantly. Two-thirds of participants in the SA arm remained on the steroid-free protocol at the end of follow-up.

SA proved to be safe and effective in patients with low immunological risk for up to 7 years following kidney transplantation. Our findings provide robust evidence supporting SA strategy with low-dose tacrolimus without compromising outcomes even at the extended 7-years follow up.