Safety and potential efficacy of tacrolimus for treatment of lupus nephritis with persistent proteinuria

CER140
2010 Vol.28, N°1
PI 0006, PF 0012
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PMID: 20346231 [PubMed]

Received: 10/01/2009
Accepted : 05/10/2009
In Press: 10/03/2010
Published: 15/03/2010

Abstract

OBJECTIVES:
To evaluate the safety and potential efficacy of tacrolimus for the treatment of patients with lupus nephritis and persistent proteinuria.
METHODS:
A total of 23 Japanese patients with lupus nephritis (21 females / 2 males) were enrolled in this study. Patients were administered tacrolimus at a dose of 2-3 mg once daily after the evening meal for 6 months. The dose of tacrolimus was unchanged throughout the study period. Concomitant prednisolone therapy was unchanged or gradually tapered, while other immunosuppressants were stopped at the start of tacrolimus treatment.
RESULTS:
Tacrolimus was well tolerated, and none of the patients developed adverse drug reactions that required discontinuation of the study. Daily urinary protein loss, the U-prot/U-creat ratio, and serum albumin were significantly improved after 4 months, 3 months, and 1 month of treatment with tacrolimus (p<0.05), respectively, and the improvement persisted until 6 months. The serum complement hemolytic activity (CH50), complement C3 level, and CRP level were also significantly improved after treatment with tacrolimus (p<0.05). Improvement of the U-prot/U-creat ratio was most prominent for patients who were in WHO class IV.
CONCLUSIONS:
Tacrolimus is safe and effective as maintenance therapy for patients with lupus nephritis, at least for 6 months. A larger randomised, controlled trial over a longer period is needed to confirm these results.