Mycophenolate sodium for subacute cutaneous lupus erythematosus resistant to standard therapy

Br J Dermatol. 2007 Jun;156(6):1321-7. doi: 10.1111/j.1365-2133.2007.07826.x. Epub 2007 Apr 4.


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.

Objectives: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Drug Resistance
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Lupus Erythematosus, Cutaneous / complications
  • Lupus Erythematosus, Cutaneous / drug therapy*
  • Lupus Erythematosus, Cutaneous / immunology
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage*
  • Pilot Projects
  • Prospective Studies
  • Severity of Illness Index
  • Treatment Outcome


  • Immunosuppressive Agents
  • Mycophenolic Acid