Objective: The purpose of this study was to compare the efficacy of leflunomide in combination with reduced immunosuppression versus reduction of immunosuppression alone for the prevention of BK nephropathy in renal transplant recipients.

Methods: This single-center, retrospective chart review included transplant recipients with a detectable plasma BK viral load between February 2011 and November 2014. All patients at least 18 years of age who received a kidney or kidney-pancreas transplant were included. Patients who developed BK virus nephropathy before any therapeutic intervention was implemented were excluded. The primary outcome was BK virus-induced nephropathy. Secondary outcomes include clearance of BK viremia and patient and graft survival.

Results: A total of 56 patients were included in the analysis: 38 in the leflunomide in combination with reduced immunosuppression group (LEF group) and 18 in the reduction of immunosuppression alone group (IS group). The incidence of BK nephropathy was 24% in the LEF group versus 0% in the IS group (p= 0.05). Over the course of study follow-up, 58% of patients in the LEF group cleared the BK virus versus 83% of the IS group (p= 0.07). The median time to clearance of BK was 308 days in the LEF group and 71 days in the IS group. Overall, patient and graft survival were good in both groups. There was 1 patient death and 2 graft losses in the LEF group and 3 patient deaths in the IS group.

Conclusion: Reduction in immunosuppression remains the gold standard for prevention of BK nephropathy. The results of this study indicate that the addition of leflunomide does not obviate the need to aggressively reduce immunosuppression. Further analysis of the overall level of immunosuppression in both treatment groups and its affect on progression of BK is warranted.

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