Ineffectiveness of cyclosporine as an adjuvant to corticosteroids in the treatment of pemphigus

Objective: To compare the effectiveness and the adverse effects of 2 differ ent regimens for the treatment of pemphigus: corticosteroids alone compared with a combination of corticosteroids and cyclosporine. Design: Concurrently randomized trial. Setting: Tertiary care medical center. Patients and Methods: We studied 33 sequential hospitalized patients with n ewly diagnosed pemphigus vulgaris (n=29) or pemphigus foliaceous (n=4) base d on clinical, histological, and immunofluorescence criteria who had not pr eviously been treated with systemic corticosteroids or immununosuppressive drugs. Patients were randomly assigned to treatment with methylprednisolone or prednisolone plus cyclosporine. Intervention: Both groups were treated with similar initial doses of predni solone (prednisone equivalent, 1 mg/kg), which were increased 50% every 5 t o 10 days based on persistence of disease activity. One group was treated i n addition with cyclosporine (5 mg/kg). Main Outcome Measures: Patients were followed up closely for clinical outco me based on time required to control active manifestations of the disease, induction of partial and complete remissions, total amount of corticosteroi ds administered, frequency of relapses, and development of complications. Results: The 2 groups were similar in terms of demographics and baseline di sease severity. There was no difference between groups in any of the variab les used to measure response to treatment or total amount of corticosteroid s administered. Complications were more common in patients who received com bination therapy. Conclusion: Combination treatment with corticosteroids and cyclosporine, 5 mg/kg, offers no advantage over treatment with corticosteroids alone in pat ients with pemphigus.