Background/Purpose:

Leflunomide(LEF) is an effective immunosuppressant. In China, one phase III study has reported that compared with cyclophosphamide, LEF in combination with prednisone was effective in the induction therapy of proliferative lupus nephritis (LN). In 2009, The China Food and Drug Administration(CFDA) has approved LEF(leflunomide tablets, Cinkate) in the treatment of LN. However, long-term data of LEF in the maintenance treatment of LN are lacking.

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:

As the registration study, 70 patients were enrolled into LEF induction group with a loading dose of 50mg/day for 3 days, followed by 30mg/day for six months. The partial and complete remission rate was 52% and 21%. Among them, 15 patients voluntarily entered an open labeled extension study.

Results:

A total of 15 patients (mean age 39.9±7.7years) were treated with LEF for >12 months,the mean duration of LEF treatment was 11.5 years (range 8.0–13.6 years); 86.6% (13/15) of the patients were female. The mean disease duration was 14.2±3.5 years (range 8.5–23.4 years). During a median follow-up period of 11.9 years, 1 patient died from sepsis, 4 patients developed renal flare, none of patients developed in sustained doubling of serum creatinine or end-stage renal failure. 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 64.28%(9/14), the partial remission rate was 35.72%(5/14),the mean proteinuria leval was 0.47g/day(range 0.09–1.62g/day), and the mean serum creatinine leval was 66.1umol/L(range 46-90umol/L).

Conclusion:

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. LEF can be considered as a option as maintenance therapy for patients with lupus nephritis, but its role as a long-term maintenance agent warrants further investigation.

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-long-term-outcomes-on-leflunomide-treatment-in-patients-with-lupus-nephritis-a-twelve-year-follow-up-study/