Rheumatology Medical News about Tacrolimus, Lupus nephritis, Glucocorticoid

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Efficacy and safety of tacrolimus for lupus nephritis: A placebo-controlled double-blind multicenter study
Modern Rheumatology, 08/24/09

Miyasaka N et al. – In patients on glucocorticoid therapy for lupus nephritis, addition of tacrolimus to basal therapy achieved significant improvement; tacrolimus may therefore be a useful alternative treatment for lupus nephritis.

Methods

An evaluation of the efficacy and safety of tacrolimus in pts receiving glucocorticoid therapy for lupus nephritis
Patients with persistent nephritis randomized to receive 28 wks of double-blind treatment with tacrolimus (3 mg/d) or placebo
Primary endpoint: change in the lupus nephritis disease activity index (LNDAI) calculated from scores for-
- Daily urinary protein excretion
- Urinary red cells
- Serum creatinine
- Anti-double-stranded DNA antibody, and
- Serum complement
Statistical analysis was performed using the full analysis set

Results

The LNDAI was decreased by 32.9% in the tacrolimus group (n=28) and was increased by 2.3% in the placebo group (n=35) at final evaluation
There was significant improvement in the tacrolimus group
Daily urinary protein excretion showed a significant decrease in the tacrolimus group
The complement (C3) level showed a significant increase in the tacrolimus group
Treatment-related AEs occurred in 92.9% of the tacrolimus group and 80.0% of the placebo group, but the difference was not significant

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