Steroid-sparing effect of tacrolimus in the maintenance phase of systemic lupus erythematosus: a single-center, prospective study

Abstract

76Yusuke Miwa et al. AbstractObjective: The purpose of this study was to prospectively assess the steroid-sparing effect and safety of Tacrolimus (TAC) combination treatment during the maintenance phase of SLE.Methods: Thirty-eight patients were studied over a 1-year period from 2009 to 2012. If manifestations of mild active SLE, such as skin eruptions, arthritis, or asymptomatic nephritis, worsened and/or decreasing levels of serum complement (C3c) were observed, TAC combination treatment (from 1 mg to 5 mg once daily) was carried out. This was accomplished by adding TAC to the patient's existing treatment regimen and decreasing in the usage of prednisolone (PSL). Scores on the SLE Disease Activity Index (SLEDAI), PSL dosage, and proteinuria, serum levels of C3c, anti-dsDNA levels were researched.Results: Twenty-eight patients received to TAC combination therapy. 1) The PSL dose was decreased from 11.7 ± 5.6 to 8.2 ± 4.2 mg/day (P<0.001).2) The serum concentration of C3c increased and levels of anti-dsDNA antibodies decreased 3) Scores on the SLEDAI modified from 6.2 ± 3.7 to 2.6 ± 2.3 (P<0.001). There were no significant differences in proteinuria. In contrast, eight patients did not respond and/or had worsening SLE, and two patients discontinued treatment because of an adverse effect such as rhabdomyolysis or muscle cramps. No patients had complications of an abnormal urinalysis, and none progressed to renal failure with or without requiring dialysis.Conclusions: TAC combination treatment may have a useful steroid-sparing effect, as it does not worsen disease activity and is safe for SLE patients during the maintenance phase.

Influence of renal complications on the efficacy and adverse events of tacrolimus combination therapy in patients with systemic lupus erythematosus (SLE) during a maintenance phase: a single-centre, prospective study

“… 19–21 Maintenance therapy of SLE was previously reported only in studies of patients with or without lupus nephritis, 12 13 22 including one small group study and one short-duration study. 14 15 No previous assessments of long-term TAC therapy were reported in a larger group of patients with SLE with and without renal complications, as performed in this study. We investigated whether renal complication affected the efficacy and safety of TAC combination therapy in patients with SLE during a maintenance phase.…”

“…For example, one small-scale study reported an approximately 6-month observation period, 14 and a clinical practice report of 38 cases used TAC for 1 year. 15 However, there have not been reports of a large-scale clinical practice study, such as the inclusion of more than 50 cases followed up for 1 year. However, one report suggested that the long-term use of TAC caused renal dysfunction.…”