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An article published in Transplantation [83(12): 1571–1576, June 27, 2007] described how twenty-six liver recipients, who had been free of rejection while on immunosuppressive agents for a minimum of 2 years, were randomized to receive either 15 mg/kg of Ursodeoxycholic Acid (UDCA, n=14) or identical placebo (n=12) followed by sequential withdrawal of their immunosuppressive regimen over several months. Endpoints were defined as biochemical and histological evidence of rejection, graft dysfunction without rejection, recurrence of pretransplant disease, or 6 months without immunosuppression and no rejection or dysfunction on repeat liver biopsy.
Rejection occurred in 6 of 14 (43%) of the UDCA group and 9 of 12 (75%) of those receiving placebo (P=0.09). The degree of rejection was mild, moderate, and severe in 73%, 20%, and 7% of patients respectively. All responded to rescue therapy and none developed chronic rejection. Nine of the remaining 11 patients (eight of the UDCA recipients and three of controls) who did not develop rejection developed graft dysfunction which responded to reintroduction of immunosuppressive agents in each case. Disease recurrence was most common in patients with underlying immune-mediated disorders of the liver. One year after withdrawal only two patients were free of immunosuppression, 80% were able to discontinue prednisone therapy (steroid free), and 50% were able to reduce their dose of cyclosporine. Age, underlying cause of liver disease, and regimen of immunosuppression were favorable predictors.The results of this study suggest that total immunosuppression withdrawal (TIW) is frequently associated with subsequent rejection, increases the risk of underlying disease recurrence, and is not facilitated by UDCA use and responds properly to the reintroduction of immunosuppressive therapy.
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