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Published on: November 8, 2015
Management of young patients with lupus nephritis using tacrolimus administered as a single daily dose
1Department of Pediatrics, Hirosaki University School of Medicine, 5 Zaifu-cho, Hirosaki, 036-8562, Japan. hirotana@cc.hirosaki-u.ac.jp
Insights
Low-dose tacrolimus (Tac) effectively manages pediatric lupus nephritis (LN) in young patients. This immunosuppressive therapy showed significant clinical and serological improvements with minimal adverse effects, suggesting a safe treatment option.
Area of Science:
- Nephrology
- Immunology
- Pediatric Rheumatology
Background:
- Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE).
- Limited studies exist on tacrolimus (Tac) for immunosuppressive maintenance therapy in pediatric LN.
- Long-standing pediatric-onset LN requires effective and safe long-term management strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of low-dose, once-daily tacrolimus (Tac) as maintenance therapy for pediatric-onset, long-standing lupus nephritis (LN).
- To assess clinical and serological responses in young patients receiving Tac and prednisolone (PDN).
Main Methods:
- An open-label trial involving 11 consecutive patients with biopsy-proven, long-standing LN.
- Patients received daily single-dose tacrolimus (3 mg/day) for 6-24 months without increased prednisolone doses.
- Prospective collection of clinical parameters and serologic lupus activity data.
Main Results:
- Significant improvement in European Consensus Lupus Activity Measurement (ECLAM) index at 1 month and serological markers at 3 months.
- Marked reduction in urinary protein/creatinine ratio (Up/cr) by 24 months.
- Complete response in 73% of patients (8/11) and partial response in 2 patients (18%) after a mean of 18 months, with no serious adverse effects.
Conclusions:
- Low-dose, once-daily tacrolimus (Tac) is an effective and safe maintenance therapy for selected young patients with pediatric-onset, long-standing lupus nephritis (LN).
- Further larger-scale studies are warranted to confirm these promising findings.
Aims:
Studies on immunosuppressive treatment with tacrolimus (Tac) in subjects with lupus nephritis (LN) are limited. Here, we report our experience with Tac administered daily as a single-dose for maintenance therapy in young patients with pediatric-onset, long-standing LN.
Methods:
Eleven consecutive patients with long-standing biopsy-proven LN were recruited for at least 6 months or longer (6 - 24 months) as part of an open-label trial for the single-daily-dose administration of Tac (3 mg/day, 0.04 - 0.075 mg/kg) without dose increases of concomitantly administered prednisolone (PDN). Tac treatment was started at the time of the most recent flare. Data on clinical parameters and serologic lupus activity were collected prospectively.
Results:
The baseline characteristics of the patients were as follows: mean age, 18 years; urinary protein/creatinine ratio (Up/cr), 0.74 +/- 1.49; serum C3 level, 69.5 +/- 26.5 mg/dl (normal 79 - 152 mg/dl); serum complement hemolytic activity (CH50), 23.0 +/- 8.9 U/ml (normal 23 - 46 U/ml); serum anti-dsDNA antibody titer, 58.9 +/- 54.2 IU/ml (normal < 12.0 IU/ml); serum creatinine, 0.54 +/- 0.13 mg/dl; and European Consensus Lupus Activity Measurement (ECLAM) index, 4.4 +/- 2.2. Despite the gradual tapering of the PDN dose, a marked improvement, compared with the baseline values was observed in the ECLAM index even at 1 month and in the serological parameters at 3 months after the start of treatment. These favorable results persisted until the end of the study. The Up/cre ratio gradually decreased and had dropped significantly at 24 months after the start of treatment. After a mean of 18 months of treatment, complete responses were achieved in 8 patients (73%) and a partial response was achieved in 2 patients. The remaining one patient showed no response. No serious adverse effects were observed.
Conclusion:
These data suggest that low-dose Tac treatment, administered once daily, is an effective and safe method for managing selected young patients with pediatric-onset, long-standing LN. However, further studies involving a larger number of patients are needed to confirm these results.
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