Background In Japan, a placebo-controlled clinical trial was undertaken to investigate the efficacy and safety of tacrolimus (TAC) for lupus nephritis.
To our knowledge, there has been no previous comparison of systemic lupus erythematosus (SLE) with and without renal involvement in the context of TAC treatment.
Objectives The aim of this study was to prospectively evaluate the efficacy and safety of TAC combination therapy for SLE with (Group A) or without (Group B) renal involvement during the maintenance phase.
Methods From 2009 to 2013, 38 patients were examined in a single-hospital, prospective cohort study over a one-year period. If manifestations of mild active SLE, such as arthritis, skin eruptions, or asymptomatic nephritis, worsened and/or decreasing titers of serum complement (C3c) were observed, TAC combination therapy (from 1 mg to 5 mg once daily) was administered (e.g., TAC was added to the patient's existing treatment regimen, and the dosage of prednisolone (PSL) was decreased). Scores on the SLE disease activity index (SLEDAI); PSL dosage; and serum levels of creatinine, C3c, anti-dsDNA titers, and proteinuria were measured. Evidence of renal involvement was detected by laboratory tests: proteinuria was defined as >0.5 g/day, and cellular debris were detected on urinalysis or pathological findings of lupus nephritis by renal biopsy. The main outcome was the efficacy of SLE treatment”. In this study, Welch's t-test, Fisher's exact probability test and repeated measures ANOVA were used for statistical analysis.
Results The dosage of PSL was reduced, the serum concentration of C3c increased, titers of anti-dsDNA antibodies decreased and SLEDAI scores improved in both groups (p<0.05). In particular, the following symptoms improved by the SLEDAI: headache (from 7 patients to 1 patient), arthritis (from 3 patients to 0 patients), rash (from 6 patients to 2 patients), alopecia (from 5 patients to 0 patients), mucosal ulcers (from 2 patients to 0 patients), and fever (from 5 patients to 1 patient). According to an analysis by repeated measures ANOVA, serum C3c levels improved from 66.9±16.7 to 83.5±14.2 mg/dl (p=0.021) in Group A, and proteinuria improved from 0.09±0.25 to 0.0±0.0 g/g Cr in Group B. There were no significant differences between Groups A and B in terms of age, sex, disease duration, rate of ACE/ARB use or the rate of statin use before TAC treatment. Two patients discontinued treatment as a result of an adverse effect: muscle cramp or rhabdomyolysis. No patients experienced complications with adverse effects of abnormal urinalysis, and none progressed to renal failure or became candidates for dialysis.
Conclusions TAC combination therapy is a useful alternative treatment for SLE despite the presence or absence of renal involvement.
Disclosure of Interest K. Otsuka: None declared, Y. Miwa Grant/research support: astellas, N. Oguro: None declared, Y. Miura: None declared, S. Ishii: None declared, S. Seki: None declared, H. Furuya: None declared, R. Yanai: None declared, R. Takahashi: None declared, K. Wakabayashi: None declared, T. Isozaki: None declared, N. Yajima: None declared, T. Kasama Grant/research support: astellas
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