title: Effective plasma concentrations of mycophenolic acid and its glucuronide in systemic lupus erythematosus patients in the remission-maintenance phase.
abstract: OBJECTIVE
  Mycophenolate mofetil (MMF) has been reported recently to be effective in the treatment of systemic lupus erythematosus (SLE). The therapeutic range of mycophenolic acid (MPA) in SLE in the remission-maintenance phase remains to be clarified. The aim of this study was to evaluate the therapeutic efficacy of MMF and predose plasma concentrations of MPA and its phenolic glucuronide (MPAG) in patients with SLE in the remission-maintenance phase.
  
  
  METHODS
  Thirty-one patients with SLE receiving a fixed dosage regimen of MMF (median and interquartile range, 1500 and 1000-2000mg/day) for at least 1month and who had not experienced any adverse drug reactions for more than 3months were enrolled.
  
  
  RESULTS
  Significant improvement was observed after MMF administration in total haemolytic complement CH(50) and its fractions C3 and C4, immunoglobulins IgG, IgA and IgM, anti-dsDNA antibody, serum concentration of albumin and red blood cell count, even though the mean daily dose of prednisolone was significantly reduced (P=0·02). Median predose plasma concentrations of MPA and MPAG were 1·95 and 26·2μg/mL (interquartile ranges, 0·94-2·96 and 18·6-53·7 μg/mL). Predose plasma concentrations of MPA and MPAG correlated significantly with MMF dose (r=0·64, P<0·01 and r=0·39, P=0·03).
  
  
  CONCLUSIONS
  MMF improved clinical laboratory markers and reduced prednisolone dosage in SLE patients with predose plasma concentration of MPA and MPAG in the interquartile ranges of 0·94-2·96 and 18·6-53·7μg/mL, respectively.
authors.affiliation: Department of Hospital Pharmacy, Hamamatsu University School of Medicine, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Mino
authors.forename: T
authors.initials: T
authors.lastname: Naito
authors.forename: K
authors.initials: K
authors.lastname: Shimoyama
authors.forename: N
authors.initials: N
authors.lastname: Ogawa
authors.forename: J
authors.initials: J
authors.lastname: Kawakami
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D020719:Glucuronides / Q000493:pharmacokinetics; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D020719:Glucuronides; D007166:Immunosuppressive Agents; C113145:mycophenolic acid glucuronide; D011239:Prednisolone; D009173:Mycophenolic Acid