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252 The long-term outcomes on leflunomide treatment in patients with lupus nephritis: a twelve-year follow-up study
  1. W Minjun1,
  2. Y Gong2 and
  3. F Xiao2
  1. 1Shanghai, China
  2. 2Cinkate Corp., Medicial and Marketing Department, Shanghai, China

Abstract

Background and aims One phase III study has reported that Leflunomide(LEF) in combination with prednisone was effective in the induction therapy of proliferative lupus nephritis (LN). However, long-term data of LEF in the maintenance treatment of LN are lacking. The aim of this study was to investigate the long-term outcomes of LEF in the maintenance treatment of LN in an open-label extension of a prospective multi-centre observational study.

Methods 70 patients were enrolled into LEF induction group with a loading dose of 50 mg/day for 3 days, followed by 30 mg/day for six months. The partial and complete remission rate was 52% and 21%. Among them, 15 patients voluntarily entered an open labelled extension study. Data for survival and kidney function were prospectively collected during a 12 year period for the 15 patients who were maintained on 20 mg/day LEF.

Results 15 patients (mean age 40.2±7.4 years; 86.6% female) were treated with LEF for >12 months,the mean duration of LEF treatment was 11.8 years. During a median follow-up period of 12.3 years, 1 patient died from sepsis, 4 patients developed renal flare. The 12 year cumulative survival rates for the composite end point of death and chronic renal failure were 93.3% and 100%, respectively. At the final follow-up, the complete remission rate in the remaining patients was 71.43%, the partial remission rate was 28.57%,the mean proteinuria leval was 0.33g/day(range 0.07–1.62 g/day), and the mean serum creatinine leval was 62.3 umol/L.

Conclusions Our data suggest that a remission-inducing regimen of LEF followed by maintenance therapy with LEF resulted in good long-term patient survival and renal preservation.

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