Cessation of corticosteroids does not confer excess risk for allograft failure over the long term, according to new data.
In a trial of 385 recipients (mean age 46.5 years) of a living or deceased donor kidney transplant who were at low-to-moderate immune risk (peak panel reactive antibody less than 50% and pretransplant panel reactive antibody less than 25%), investigators randomly assigned 191 patients to withdraw from corticosteroids within 7 days and 194 patients to continue corticosteroids at a dose of 5 mg per day, in addition to taking tacrolimus and mycophenolate mofetil. The study excluded patients who had short-term delayed graft function or rejection in the first week after transplantation (defined by a minimum 30% reduction in pretransplant serum creatinine level within 7 days).
In 2008, the investigators reported no significant differences between groups in 5-year graft loss (composite outcome). In the current study, the investigators provided longer-term follow up data using the Organ Procurement and Transplant Network registry. Over a median 15.8 years, allograft failure from any cause or censored for patient death did not differ significantly between the groups who continued or discontinued corticosteroids, John S. Gill, MD, MS, of St Paul’s Hospital in Vancouver, BC, Canada, and colleagues reported in JAMA Surgery.
“Long-term corticosteroids may not be necessary as part of a calcineurin-based multiple drug immunosuppressive regimen in low-to-moderate immune risk kidney transplant recipients,” Dr Gill’s team concluded.
In an accompanying editorial, Arthur J. Matas, MD, of the University of Minnesota in Minneapolis, Minnesota, reaffirmed this point, noting that the new study “provides convincing long-term data showing that recipients of transplants are not penalized by [early steroid cessation]. Going forward, in contrast with justifying [early steroid cessation], transplant centers using steroids should justify why they are using steroids for their recipients or recipient subpopulations, given that there is no evidence of improved outcomes and steroids have adverse effects.”
Common steroid complications include new-onset diabetes, avascular necrosis of the hip, premature onset of cataracts, mood changes, Cushingoid appearance, and skin changes, Dr Matas noted.
Disclosure: This clinical trial was supported by Astellas. Please see the original reference for a full list of authors’ disclosures.
Woodle ES, Gill JS, Clark S, Stewart D, Alloway R, First R. Early corticosteroid cessation vs long-term corticosteroid therapy in kidney transplant recipients: long-term outcomes of a randomized clinical trial. Published online February 3, 2021. JAMA Surg. doi:10.1001/jamasurg.2020.6929
Matas AJ. Early steroid cessation after kidney transplant. Published online February 3, 2021. JAMA Surg. doi:10.1001/jamasurg.2020.6959
Woodle ES, FirstMR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008;248(4):564-577. doi:10.1097/SLA.0b013e318187d1da