Clinical assessment of tacrolimus therapy in lupus nephritis: one-year follow-up study in a single center.

BACKGROUND/AIMS: The purpose of this study was to examine whether tacrolimus is effective and safe, and to determine the optimal dose of tacrolimus for maintenance treatment in patients with lupus nephritis (LN).

METHODS

A total of 17 adult patients (1 man and 16 women) with LN were enrolled. Tacrolimus was initiated at a dose of 3 mg/day which was administered once per day after the evening meal. Prospective data on renal response and serologic lupus activity were collected and followed for a year.

RESULTS

Mean age at baseline was 48.8 +/- 12.6 years (range 31-72 years). The mean urinary protein/creatinine ratio significantly decreased from 1.14 +/- 1.74 at baseline to 0.23 +/- 0.47 at 1 year (p < 0.05). Mean serum C3 significantly increased from 73.0 +/- 12.3 mg/dl at baseline to 84.7 +/- 12.2 mg/dl at 1 year (p < 0.01). Mean serum creatinine levels were unchanged after tacrolimus treatment. The mean blood concentration of tacrolimus was 3.9 +/- 2.1 ng/ml. There was no relationship between the incidence of adverse effects and blood tacrolimus level.

CONCLUSION

Our results suggest tacrolimus to be potentially effective and safe for maintenance treatment in patients with LN.