title: Mycophenolate sodium for subacute cutaneous lupus erythematosus resistant to standard therapy.
abstract: BACKGROUND
  Approximately 75-95% of patients with cutaneous lupus erythematosus respond to antimalarial therapy and/or topical glucocorticosteroids. Immunosuppressive agents are usually considered a second-line approach in patients with resistant disease.
  
  
  OBJECTIVE
  This was a prospective, nonrandomized, open pilot study to evaluate the efficacy of mycophenolate sodium monotherapy in patients with recalcitrant subacute cutaneous lupus erythematosus (SCLE).
  
  
  METHODS
  Monotherapy with oral enteric-coated mycophenolate sodium 1440 mg daily was given for a total of 3 months. Treatment outcome was evaluated by means of a validated clinical score for cutaneous lupus erythematosus, the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), as well as 20-MHz ultrasound measurements and colorimetry. Safety assessment included the monitoring of adverse effects and clinical laboratory parameters.
  
  
  RESULTS
  Ten patients with active SCLE resistant to at least one standard therapy were included in the trial. Mycophenolate sodium led to a remarkable improvement of skin lesions, resulting in a significant decrease of the mean +/- SD CLASI from 10.8 +/- 6.0 at the beginning to 2.9 +/- 2.6 at the end of therapy. Clinical improvement was confirmed by ultrasonographic assessments and colorimetry. No serious side-effects were noted.
  
  
  CONCLUSIONS
  Mycophenolate sodium is beneficial and safe in the treatment of patients with SCLE that failed standard therapy. However, these preliminary data must be confirmed by randomized controlled trials including a larger sample size.
authors.affiliation: Connective Tissue Disease Research Unit, Department of Dermatology and Allergology, Ruhr University Bochum, Bochum, Germany. a.kreuter@derma.de
authors.forename: A
authors.initials: A
authors.lastname: Kreuter
authors.forename: N S
authors.initials: NS
authors.lastname: Tomi
authors.forename: S M
authors.initials: SM
authors.lastname: Weiner
authors.forename: M
authors.initials: M
authors.lastname: Huger
authors.forename: P
authors.initials: P
authors.lastname: Altmeyer
authors.forename: T
authors.initials: T
authors.lastname: Gambichler
mesh_terms: D000328:Adult; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008178:Lupus Erythematosus, Cutaneous / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage*; D010865:Pilot Projects; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid