Thalidomide: new preparation. For well-defined indications.

(1) Thalidomide is highly teratogenic. It can also cause irreversible neuropathy. (2) In type II lepra reactions evidence of efficacy at a dose of 400 mg/day is based on a few relatively old comparative trials and above all a review of more than 4,500 cases. Most patients feel a benefit within 24-48 hours after beginning the treatment, but most also require lengthy treatment at a reduced dose (25-100 mg/day) to avoid relapses. (3) Two placebo-controlled trials involving a total of 130 patients have shown the efficacy of thalidomide in the treatment of severe recurrent aphthous disease. (4) In Jessner-Kanoff disease, a mild condition, the efficacy of thalidomide has been shown in a single placebo-controlled trial. (5) In chronic lupus erythematosus, non comparative trials have shown remission from skin lesions in patients resistant to previous treatments. (6) In the curative treatment of chronic graft-versus-host disease in bone marrow graft recipients, thalidomide has been assessed only in non comparative trials involving a few dozens of patients.