Experience with low-dose thalidomide therapy in chronic discoid lupus erythematosus

Int J Dermatol. 2000 Mar;39(3):218-22. doi: 10.1046/j.1365-4362.2000.00953.x.


Background: Low-dose thalidomide therapy (median dose 100 mg/day, 50-200 mg/day) in chronic discoid lupus erythematosus was studied with regard to efficacy, tolerance, and toxicity in 22 patients. Intense contraceptive precautions were taken in women patients of childbearing age.

Methods: An open uncontrolled trial was conducted. Age, the total drug intake, disease duration, extent/severity, and adverse reactions were studied with regard to the final clinical outcome. The follow-up duration was 1.8 years (range 1 month to 3 years).

Results: With the exception of age (inverse correlation, P < 0.01), the parameters studied did not influence the final clinical amelioration: complete responders numbered 54.5%, partial responders 22.7%, and 13.6% were withdrawn from the trial with complaints of intolerance. The initial (first month) clinical response correlated significantly with the final one (P < 0.01). Drowsiness (40.9%) and somnolence (18.2%) were the most common side-effects, without affecting seriously the daily life of the participants. No case of real neurotoxicity was confirmed. Relapses occurred within 39.4 +/- 21.4 days after drug withdrawal, presenting a milder clinical picture.

Conclusions: In the context of a predictable final outcome, low-dose thalidomide therapy is effective as an alternative choice in cases resistant to the usual treatment.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Appetite / drug effects
  • Constipation / chemically induced
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Lupus Erythematosus, Discoid / drug therapy*
  • Male
  • Menstruation Disturbances / chemically induced
  • Middle Aged
  • Paresthesia / chemically induced
  • Patient Dropouts
  • Recurrence
  • Remission Induction
  • Skin / drug effects
  • Skin / pathology
  • Sleep Stages / drug effects
  • Thalidomide / adverse effects
  • Thalidomide / therapeutic use*
  • Treatment Outcome


  • Immunosuppressive Agents
  • Thalidomide