Low-dose tacrolimus therapy for patients with refractory lupus nephritis who were resistant to cyclophosphamide was effective and safe, according to study results.
Researchers in China evaluated 26 patients with lupus nephritis (LN; mean age, 29.36 years; 22 women) with persistent proteinuria who were resistant to cyclophosphamide (CYC) treatment (>8 g in less than 6 months). Patients had a mean duration of systemic lupus erythematosus (SLE) of 5.20 years and a mean duration of LN of 2.91 years.
Tacrolimus was weight based and initiated at 2 mg/day (<60 kg) or at 3 mg/day (≥60 kg), and administered in two divided doses. Tacrolimus serum levels were monitored at 2 weeks and 1, 2, 4 and 6 months. Data on daily proteinuria, serum albumin level and serologic lupus activity were collected.
At 6 months, mean daily proteinuria significantly decreased from 6.91 g ± 4.50 g (baseline) to 1.11 g ± 1.10 g, while mean serum albumin significantly increased from 25.56 g/L ± 7.94 g/L to 38.12 g/L ± 2.42 g/L. Patients also displayed a decrease in their mean SLE disease activity index from 11.42 ± 6.74 to 3.61 ± 2.73 (P<.001 for all).
Complete or partial response was observed in 23 (88.46%) patients at 6 months. At 2 months, 21 patients had achieved partial or complete remission. Whether patients had complete, partial or no response, there was no significant difference between tacrolimus levels. Tacrolimus was well tolerated, but one patient developed severe pulmonary infection at 4 months.
“These results suggested that tacrolimus therapy was associated with a rapid improvement of daily proteinuria and serum album level in treating LN resistant to CYC treatment,” the researchers reported. “In general, tacrolimus therapy … was well tolerated. Unlike CYC, prolonged amenorrhea or hemorrhagic cystitis was not observed. This lower incidence of side effects is the major advantage of tacrolimus use in SLE patients.”