title: 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.
abstract: OBJECTIVE
  The study investigated whether renal complications affected the efficacy and safety of tacrolimus combination therapy in patients with systemic lupus erythematosus (SLE) during a maintenance phase.
  
  
  METHODS
  Fifty-seven patients with SLE (A: 30 cases with renal complication, B: 27 cases without renal complications) were included. The presence of renal complications was defined as proteinuria ≥0.5 g/day and lupus nephritis on renal biopsy. Major outcome measures included SLE disease activity index (SLEDAI), steroid dose, serum anti-dsDNA Ab, C3 and creatinine (Cr) levels and estimated glomerular filtration rate (eGFR). The patient's background factors included age, gender, disease duration and ACE-I/angiotensin II receptor blocker and statin therapies. We compared these outcome measures pre treatment and after 1 year of treatment.
  
  
  RESULTS
  The SLEDAI and serum C3 levels improved in both groups from pretreatment period to post-treatment period: from 7.2±5.0 to 2.8±2.3 in A and 6.4±3.8 to 2.4±2.2 in B, p<0.001, and from 65.9±24.6 to 77.7±18.2 mg/dL in A and 81.8±23.0 to 90.6±19.4 mg/dL in B, p=0.002, respectively. The anti-dsDNA antibody level was reduced, and the serum Cr and eGFR levels were slightly elevated. No patients developed end-stage renal failure that required artificial dialysis.
  
  
  CONCLUSIONS
  Tacrolimus combination therapy had additive beneficial effects on reduced proteinuria and increased serum C3 levels in patients with SLE with renal complications during a maintenance phase.
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Sho
authors.initials: S
authors.lastname: Ishii
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Miwa
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Kumiko
authors.initials: K
authors.lastname: Otsuka
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Nishimi
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Airi
authors.initials: A
authors.lastname: Nishimi
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Mayu
authors.initials: M
authors.lastname: Saito
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Miura
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Nao
authors.initials: N
authors.lastname: Oguro
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Tokunaga
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Takahashi
authors.affiliation: Division of Rheumatology, Department of Medicine , Showa University School of Medicine , Tokyo , Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Kasama
keywords: Disease Activity; Lupus Nephritis; Outcomes research; Systemic Lupus Erythematosus