S G West1, S C Johnson. 1. Department of Medicine, Fitzsimons Army Medical Center, Aurora, Colorado.
Abstract
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.
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.
Authors: Luis Carreño; Francisco Javier López-Longo; Carlos Manuel González; Indalecio Monteagudo Journal: Paediatr Drugs Date: 2002 Impact factor: 3.022