April 24, 2017
The US Food and Drug Administration (FDA) has approved a medication for the prophylaxis of acute rejection in patients receiving a kidney transplant.
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Kidney transplantation is accompanied with a risk of acute rejection, which can subsequently result in graft complications and potential loss of the transplanted kidney. Thymoglobulin (anti-thymocyte globulin [rabbit], Sanofi Genzyme) is indicated in conjunction with concomitant immunosuppression for the prophylaxis of acute rejection after kidney transplant.
The FDA approval of Thymoglobulin came following the results of 2 randomized multicenter studies comparing the medicine to interleukin-2 receptor antagonists – basiliximab and daclizumab – in deceased donor kidney transplant recipients. In the first study, patients with an increased risk of acute rejection or delayed graft function (n = 278) exhibited significantly lower incidence of treatment failure within 12 months following transplantation in a Thymoglobulin cohort (25%) compared with a basiliximab cohort (38%). In the second study, patients with a high immunological risk of rejection (n = 230) demonstrated a lower incidence of treatment failure within 12 months following transplantation in a Thymoglobulin cohort (25%) compared with daclizumab (34%).
Combined analysis of both studies (n = 508) showed a composite endpoint rate within 12 months of transplantation of 25.1% in the Thymoglobulin cohort compared with 36.0% in the interleukin-2 receptor antagonist cohorts.
Adverse events associated with Thymoglobulin include leukopenia, hyperkalemia, urinary tract infection, and pyrexia.
"Thymoglobulin has been a well-established medication used in kidney transplantation for nearly 20 years, and this FDA approval is an important milestone for the transplant community," said Daniel Brennan, MD, professor of medicine, director of transplant nephrology, Barnes-Jewish Hospital, Washington University School of Medicine (St Louis, MO) in a press release (April 24, 2017). "Transplant rejection can be particularly discouraging for patients. The use of Thymoglobulin beginning just prior to transplantation may be an important step to ensuring a successful kidney implantation." – Zachary Bessette