New data from the Harmony trial show that in renal transplant recipients with a low immunological risk profile, rapid corticosteroid withdrawal after rabbit anti-thymocyte globulin (ATG) or basiliximab induction therapy can be achieved without compromising the efficacy of standard low-dose tacrolimus and mycophenolate mofetil (MMF)-based immunotherapy.

Long-term administration of steroids markedly increases the risk of cardiovascular events and post-transplant diabetes mellitus (PTDM) and their associated mortality. Although previous studies had shown that rabbit ATG induction was superior to basiliximab for prevention of biopsy-proven acute rejection (BPAR), these therapies had not previously been tested in a rapid corticosteroid withdrawal protocol.

rapid steroid withdrawal can be safely performed without compromising efficacy in a tacrolimus and MMF-based regimen

In this trial, the rate of BPAR at 1 year after transplantation with rabbit ATG treatment and rapid corticosteroid withdrawal at day 8 (9.9%) was similar to that with basiliximab and rapid steroid withdrawal at day 8 (10.6%) or with basiliximab and corticosteroid maintenance (11.2%). Patients who underwent rapid steroid withdrawal did, however, have a lower incidence of PTDM (24% with basiliximab; 23% with rabbit ATG) than those in the steroid maintenance group (39%). Graft survival was similar in all groups.

“This is the first multicentre, randomized study showing that rapid steroid withdrawal can be safely performed without compromising efficacy in a tacrolimus and MMF-based regimen,” notes Hugo. Whether low tacrolimus, MMF, induction therapy and rapid steroid withdrawal could be applied to patients with higher immunological risk and become the new standard therapy, remains to be determined.