We found no RCTs or controlled trials. The evidence for efficacy relies on a number of observational studies and a large number of case reports. The open trials, in general (but not universally), have included patients resistant to the conventional therapies of antimalarials and topical steroids.
Knop et al. reported an observational study of 60 patients with DLE resistant to conventional therapy.100 Sixty-five per cent showed complete clearing, with a further 25% having some response with 3-5 months' treatment. When treatment was stopped, 50% relapsed. Stevens et al. reported similar results in 16 patients with a variety of lesions including DLE, SCLE, and malar rash; half the patients had SLE.101 Thirteen (71%) experienced complete clearing. Similar results have been reported by Samsoen etal.,102 Atra and Sato,103 Ordi-ros etal.,104 Duong et al.,105 Hasper106 and Naas and Faber.107 The number of patients in these trials ranged from seven to 23 and the period of completed treatment varied from weeks to years. Duong et al. reported on patients who had been on treatment for 8-9 years. Low-dose maintenance therapy (50-100 mg/day) successfully controlled disease in the majority of cases.
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