Long-term corticosteroid therapy may not be necessary in kidney transplant recipients receiving calcineurin-based immunosuppressive therapy, according to a clinical trial report in JAMA Surgery.
The researchers analyzed long-term follow-up data from a previous multi-center, randomized, double-blind trial including 385 adult patients undergoing living or deceased kidney transplantation between 1999 and 2002. All patients were classified at low-to-moderate immune risk and were free of delayed graft function or short-term rejection within the first week.
Patients were assigned to tacrolimus and mycophenolate mofetil, with or without corticosteroids, 7 days after transplantation. Outcomes were assessed via linkage to the national Organ Procurement and Transplantation Network (OPTN) registry up to 2018−2019; median follow-up was 15.8 years. The primary outcome was all-cause kidney allograft failure including death, accounting for the need for long-term dialysis or repeat transplantation.
On intention-to-treat analysis, there was no significant difference in time-to-allograft failure from any cause, or in allograft failure censored for death, for patients assigned to corticosteroid withdrawal versus continuation. Similar patterns were seen in subgroup analyses, as well as on per-protocol analysis of 223 patients who stayed on their assigned treatment for at least 5 years. Outcomes were also comparable to those of 3540 patients from the OPTN registry who met the study eligibility criteria and received the same immunosuppressive drugs.
To avoid adverse effects, several studies have evaluated the effects of eliminating corticosteroids from immunosuppressive regimens after kidney transplantation. Despite positive results of clinical trials, only 30% of recipients are managed with corticosteroid withdrawal.
The new analysis supports the long-term safety of corticosteroid withdrawal in low-to-moderate immune-risk transplant recipients receiving calcineurin-based immunosuppression. At 15 years’ follow-up, patients assigned to corticosteroid withdrawal versus continuation show no significant difference in outcomes. The authors note that the original trial showed no increase in moderate-to-severe short-term rejection events in the corticosteroid withdrawal group [Woodle ES, et al. Early corticosteroid cessation vs. long-term corticosteroid therapy in kidney transplant recipients. Long-term outcomes of a randomized clinical trial. JAMA Surg, published online ahead of print February 3, 2021. doi: 10.1001/jamasurg.2020.6929; https://jamanetwork.com/journals/jamasurgery/article-abstract/2775940].