Steroid avoidance or withdrawal for kidney transplant recipients.
In this updated Cochrane review of 53 randomised trials (8317 kidney transplant recipients), steroid avoidance or withdrawal showed no difference in death or graft loss up to one year versus steroid maintenance; steroid avoidance may reduce death at one to five years and post-transplant diabetes, but may increase biopsy-proven acute rejection — although not when combined with tacrolimus, an antimetabolite and induction therapy.
Background
Steroid-sparing strategies aim to reduce the adverse effects of long-term corticosteroids after kidney transplantation, but earlier systematic reviews raised concern about a higher risk of rejection. With modern immunosuppression and falling acute rejection rates, this update (previous versions 2009 and 2016) re-evaluated the benefits and harms of steroid avoidance or withdrawal.
Study design
Cochrane systematic review and meta-analysis of randomised and quasi-randomised controlled trials, with searches to 29 April 2025. It included 53 studies (8317 randomised kidney transplant recipients), three of them in children (204 participants). Random-effects models were used and certainty of evidence was graded with GRADE; overall certainty was low (moderate to very low), mainly because of risk of bias and imprecision — only five of the 53 studies blinded participants and investigators.
Key findings
Steroid avoidance versus maintenance (adults): very uncertain effect on death up to one year (RR 0.84, 95% CI 0.51 to 1.39); may reduce death at one to five years (RR 0.61, 95% CI 0.39 to 0.96; low certainty); little to no effect on death-censored graft loss up to one year (RR 0.95, 95% CI 0.62 to 1.46; moderate certainty); may increase biopsy-proven acute rejection up to one year (RR 1.58, 95% CI 1.11 to 2.25; low certainty), though subgroup analysis showed no increase when combined with tacrolimus, an antimetabolite and induction; may reduce post-transplant diabetes up to five years (RR 0.70, 95% CI 0.59 to 0.84). Steroid withdrawal versus maintenance showed little to no effect on death, graft loss, acute rejection (RR 1.41, 95% CI 0.89 to 2.23) or post-transplant diabetes (RR 0.82, 95% CI 0.55 to 1.21). Evidence comparing avoidance with withdrawal, and evidence in children, was very uncertain.
Safety
Neither strategy showed a clear difference in cardiovascular events (avoidance RR 0.73, 95% CI 0.46 to 1.18; withdrawal RR 0.91, 95% CI 0.42 to 1.97), all infections (avoidance RR 0.96; withdrawal RR 1.06) or cytomegalovirus infection (avoidance RR 1.01; withdrawal RR 1.10) compared with steroid maintenance. The main safety trade-off is the possible increase in acute rejection with steroid avoidance outside a tacrolimus-antimetabolite-induction regimen.
Category
Transplant
Source
Cochrane Database Syst Rev
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