Tacrolimus therapy for systemic lupus erythematosus without renal involvement: a preliminary retrospective study

Abstract

We conducted a pilot study to investigate whether tacrolimus was effective for treating patients with systemic lupus erythematosus (SLE) without renal involvement. Ten SLE patients with symptoms such as arthritis and erythema, but no active nephritis, were treated with tacrolimus. They included 8 women and 2 men aged from 24 to 62 years [mean +/- standard deviation (SD): 42.1 +/- 11.3 years]. Tacrolimus was administered at doses of 1-3 mg daily, and efficacy was assessed from the SLE Disease Activity Index (SLEDAI) after 1 year. Two patients ceased treatment due to adverse reactions (after 4 days for chest pain and 7 months for recurrent infections). The other 8 patients completed 1 year of treatment, and significant improvement of disease activity was observed in 6 of them. The mean (+/-SD) SLEDAI showed a significant decrease after 1 year of tacrolimus therapy, from 6.8 +/- 3.1 to 3.4 +/- 0.9; p < 0.05 by Student's paired t test. The mean (+/-SD) dose of prednisolone also decreased significantly, from 16.8 +/- 8.6 to 9.3 +/- 4.6 mg/day; p < 0.05. Although a prospective controlled study will be necessary to confirm, tacrolimus might be a treatment option for active SLE without renal involvement.

Efficacy and Safety of Nonbiologic Immunosuppressants in the Treatment of Nonrenal Systemic Lupus Erythematosus: A Systematic Review

“…Two studies assessed the efficacy and/or safety of TAC in the treatment of nonrenal manifestations of SLE; both were cohort studies () that included 31 patients. In the open‐label prospective 24‐week study by Suzuki et al (), 21 patients with mild active SLE treated with oral TAC (1–6 mg/day) were studied.…”

Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real-world study

“…5 Tacrolimus is a medication that induces an immunosuppressive effect, and in recent years, it has been widely used in the treatment of SLE. [6][7][8][9][10][11][12][13][14][15] However, tacrolimus has a narrow therapeutic window and displays considerable interindividual and intra-individual variabilities in its pharmacokinetics, with poor correlation between drug dosage and blood concentrations, making it difficult to define an optimal dose schedule. 16,17 With population pharmacokinetics (PPK), pharmacokinetic information can be acquired from sparse data pooled in a large group of subjects.…”

“…Thus, tacrolimus affects the growth and differentiation of T and B lymphocytes, thereby inhibiting immunity [36][37][38]. So, tacrolimus has been widely used for treating SLE,[6][7][8][9][10][11][12][13][14][15] in which cells are damaged by distinct immunologic abnormalities. I G U R E 2 Goodness-of-fit plots of the base population model.…”

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

“…[17] Subsequently, several reports have noted the efficacy of TAC for nephritis. [18][19] [20] Maintenance therapy of SLE has been reported only in studies of patients with lupus nephritis or without lupus nephritis, [21][22] [23] and in a small group study and a short-duration study. [24][25] Thus, there have been no previous assessments of long-term TAC therapy in a larger group of SLE patients with/without nephropathy, as performed in this study.…”