Assessment of the therapeutic benefit of oral prednisolone and common adjuvant therapy in stage II of randomized controlled trial study for management of pemphigus vulgaris.

Abstract

Pemphigus is an autoimmune blistering mucocutaneous disorder. Common treatments include corticosteroids and immunosuppressive drugs. This study aimed to assess the therapeutic effects of oral prednisolone along with the common adjuvant therapy in pemphigus vulgaris. Eighty-seven patients with pemphigus vulgaris from the first stage of a previously randomized clinical trial were enrolled in the present non-blinded clinical trial. The patients were divided into four groups and treated accordingly with prednisolone alone (P; N = 23), prednisolone and azathioprine (P/A; N = 23), prednisolone and mycophenolate mofetil (P/M; N = 21), and prednisolone and cyclophosphamide (P/C; N = 20). These patients were followed-up for an extended one-year period. The primary localization of the recurrence occurred in the oral cavity of 7, 6, 2, and 5 patients in the P, P/A, P/M, and P/C groups, respectively. There was no significant difference between them (P = 0.40). The mean total dose of prednisolone administered in groups P, P/A, P/M, and P/C was accordingly 7.5, 8.4, 9.2, and 8.6 mg/day. Minor recurrence of the disease in the above-mentioned groups was observed in 7 (30.4%), 5 (21.7%), 6 (28.6%), and 7 (35.0%) of the patients, respectively. With regard to the minor recurrence of the disease, there was no significant difference among the four treatment groups (P = 0.80). Since in this follow-up study no therapeutic benefit of oral prednisolone and common adjuvant therapy was found in terms of the number of minor and major recurrences, the extent to which treatment of PV can be improved upon treatment with these agents remains to be elucidated.