Danazol for the treatment of refractory autoimmune thrombocytopenia in systemic lupus erythematosus

Ann Intern Med. 1988 May;108(5):703-6. doi: 10.7326/0003-4819-108-5-703.


Study objective: to determine the efficacy of danazol therapy in patients with systemic lupus erythematosus with severe autoimmune thrombocytopenia refractory to other therapies.

Design: noncontrolled clinical trial, with a minimum of 8 weeks of therapy, the maximum determined by clinical response.

Setting: referral-based rheumatology clinic at an army medical center.

Patients: sequential sample of six patients with systemic lupus erythematosus with severe autoimmune thrombocytopenia refractory to high-dose glucocorticoids. Four patients also failed splenectomy, or cytotoxic drugs, or both.

Interventions: danazol, 200 mg four times per day, was added to the previous therapeutic regimen for at least 2 months.

Measurements and main results: all six patients had normal platelet counts within 6 weeks of starting danazol treatment. After resolution of thrombocytopenia for at least 1 month, immunosuppressive medications were tapered; one patient had a relapse. During an average follow-up of 12 months, the danazol dose was lowered in the five remaining patients but could not be discontinued without recurrence of thrombocytopenia. During danazol therapy, platelet-bound IgG antibodies and circulating immune complexes did not decrease significantly. Danazol was well tolerated.

Conclusions: danazol appears to be a useful adjunctive treatment for refractory autoimmune thrombocytopenia associated with systemic lupus erythematosus.

MeSH terms

  • Adult
  • Aged
  • Antigen-Antibody Complex / metabolism
  • Autoimmune Diseases / drug therapy*
  • Autoimmune Diseases / etiology
  • Azathioprine / therapeutic use
  • Blood Platelets / immunology
  • Combined Modality Therapy
  • Danazol / therapeutic use*
  • Drug Resistance
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunoglobulin G / metabolism
  • Lupus Erythematosus, Systemic / complications*
  • Male
  • Middle Aged
  • Pregnadienes / therapeutic use*
  • Splenectomy
  • Thrombocytopenia / drug therapy*
  • Thrombocytopenia / etiology
  • Thrombocytopenia / immunology


  • Antigen-Antibody Complex
  • Glucocorticoids
  • Immunoglobulin G
  • Pregnadienes
  • Azathioprine
  • Danazol