THE EFFICACY OF COMBINED TREATMENT WITH PREDNISONE AND CYCLOSPORINE IN PATIENTS WITH PEMPHIGUS - PRELIMINARY-STUDY

Background: Cyclosporine, a potent immunosuppressive drug, has been suggested to be beneficial in the treatment of some immune-mediated dermatoses, including pemghigus. Objective: The aim of the present study was to evaluate the efficacy and safety of combined treatment with prednisone and cyclosporine compared with prednisone alone in patients with pemphigus. Methods: Sixteen hospitalized patients with pemphigus vulgaris received combined treatment with cyclosporine and prednisone for 12 months. Cyclosporine and prednisone were given orally at an initial dose of 5 mg/kg/day and 60 to 80 mg/day, respectively. The cyclosporine dose was adjusted to obtain plasma levels of 100 to 150 ng/L. A historical control group was composed of 15 patients with pemphigus who received prednisone at an initial dose of 120 mg/day, which was decreased according to clinical response. The clinical response, serum titer of autoantibodies, and frequency of side effects during a 1-year follow-up period were evaluated and compared. Results: The 16 patients in the combined therapy group achieved clinical remission within 25 days or less, a shorter period than for the control group, although the difference was not statistically significant. New blister formation ceased after a mean of 11.1 +/- 7.9 days of onset of treatment in the combined treatment group versus 20.5 +/- 12 days in the control group (p = 0.004). Hospital stay was shorter in the combined treatment group (mean, 32.6 +/- 12.5 days) than in the control group (mean, 50.7 +/- 17.1 days; p = 0.003). The mean total cumulative prednisone dosage during hospitalization and follow-up was 8853 +/- 1915 mg in the combined treatment group versus 12,977 +/- 2093 mg in the control group (p = 0.008). Conclusion: The combined use of prednisone and cyclosporine proved to be more effective than prednisone alone in the treatment of pemphigus vulgaris, and the cyclosporine was found to have a corticosteroid-sparing effect.