Abstract
BACKGROUND/AIMS: We evaluated the efficacy and safety of tacrolimus as maintenance therapy in Korean patients with lupus nephritis (LN). METHODS: A total of 179 patients with biopsy-proven LN were included, of whom 92 received tacrolimus and 87 did not. Clinical parameters were assessed at six months and at one, two, three, and five years. Complete renal response (CR) and partial response (PR) were defined based on established criteria. Adverse events, renal flares, and poor outcomes have been reported. RESULTS: Baseline characteristics were similar, except for a higher prevalence of class V LN in the tacrolimus group. At six months, the CR rate was 49.5% in the tacrolimus group and 56.6% in the non-tacrolimus group (p = 0.308), with PR rates of 33.0% and 24.1% (p = 0.213). At one year, the non-tacrolimus group had a significantly higher CR rate (73.1% vs. 52.3%, p = 0.006), whereas the overall response rates were similar (p = 0.15). By two years, the CR rates were 71.8% in the non-tacrolimus group and 58.2% in the tacrolimus group (p = 0.031). At three years, the overall response was found 75.4% with tacrolimus and 83.1% without (p = 0.252); and at five years, these rates were 72.9% and 87.3% (p = 0.1). No significant differences in renal flares, poor outcomes, or adverse events were observed. CONCLUSION: This study has demonstrated that tacrolimus is an effective and safe maintenance therapy for achieving renal response and slowing disease progression in patients with LN who have not achieved remission.