Excellent efficacy and beneficial safety during observational five year follow-up of Rapid Steroid withdrawal after renal transplantation (Harmony FU study).

BACKGROUND: We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal in the randomized controlled one year 'Harmony' trial with 587 predominantly deceased-donor kidney transplant recipients randomized either to basiliximab or rabbit antithymocyte globulin induction therapy and compared to standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil, and corticosteroids.

METHODS: The five-year post-trial follow-up data were obtained in an observational manner at a three and a five-year visit only for those Harmony patients who consented to participate and covered clinical events that occurred from the second year onwards.

RESULTS: Biopsy-proven acute rejection and death-censored graft loss rates remained low and independent of rapid steroid withdrawal. Rapid steroid withdrawal was an independent positive factor for patient survival (adjusted hazard ratio 0.554, 95% confidence interval 0.314 to 0.976; P = 0.041).The reduced incidence of post-transplantation diabetes mellitus in rapid steroid withdrawal patients during the original one-year study period was not compensated by later incidences during follow-up. Incidences of other important outcome parameters such as opportunistic infections, malignancies, cardiovascular morbidity/risk factors, donor specific antibody formation, or kidney function did not differ during follow-up period.

CONCLUSIONS: With all limitations of a post-trial follow up study, the Harmony follow-up data confirms excellent efficacy and beneficial safety aspects of rapid steroid withdrawal under modern immunosuppressive therapy over the course of 5 years after kidney transplantation in an immunologically low-risk, elderly population of Caucasian kidney transplant recipients.(Clinical trial registration number: Investigator Initiated Trial (NCT00724022, follow-up study DRKS00005786).