Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study

J Drugs Dermatol. 2012 Oct;11(10):1224-6.


Background: Discoid lupus erythematosus (DLE) is a chronic inflammatory disorder mediated by Th1 cells. Apremilast is a novel oral PDE4 enzyme inhibitor capable of blocking leukocyte production of IL-12, IL-23, TNF-a, INF- with subsequent suppression of Th1 and Th17-mediated immune responses, and proven clinical efficacy for psoriasis as well as rheumatoid and psoriatic arthritis.

Observations: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) showed a significant (P<0.05) decrease after 85 days of treatment with apremilast 20 mg twice daily in 8 patients with active discoid lupus. The adverse events related to the drug were mild and transient.

Conclusions: This is the first open label study to use apremilast as a treatment modality for discoid lupus. Our observations indicate that apremilast may constitute a safe and effective therapeutic option for DLE.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Diarrhea / chemically induced
  • Female
  • Headache / chemically induced
  • Humans
  • Intention to Treat Analysis
  • Lupus Erythematosus, Discoid / drug therapy*
  • Lupus Erythematosus, Discoid / enzymology
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Phosphodiesterase 4 Inhibitors / adverse effects
  • Phosphodiesterase 4 Inhibitors / therapeutic use*
  • Pilot Projects
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives*
  • Thalidomide / therapeutic use
  • Young Adult


  • Phosphodiesterase 4 Inhibitors
  • Thalidomide
  • apremilast