Background: Pemphigus vulgaris is an autoimmune blistering disease in which pathogenic autoantibodies are responsible. The immunosuppressive agents which target autoantibodies production could suppress disease activity. Although corticosteroid is the choice of therapy, the efficacy and safety of other immunosuppressive agents such as rituximab which selectively target CD20 B cells, are under investigation.
Objective and main outcome:To determine the efficacy of rituximab in the reduction of prednisolone dose
Exclusion and inclusion criteria:the patients with refractory and recurrent Pemphigus vulgaris that are candidates for rituximab will be enrolled.Exclusion criterion are pregnancy and breast feeding,history of sensitization to murine protein,hepatitis B cariers,cardiac arrhythmias & angina pectoris,high tumor burden,active infections.
Design, setting and conduct: The enrolled patients will be taken rituximab 500 mg intravenously weekly for 4 weeks in each cycle. In the regular examinations (weekly for 1 month and then monthly after injecting rituximab), the therapeutic effects will be estimated by clinical remission including, new blisters per day, Nikolsky’s sign and epithelialization over the denuded surfaces, plus side effects and relapse .The dose of oral prednisolone prior to treatment, 3 months, 6 months and the final in the last visit for each patient will be written.Finally the results will be analyzed to determine the efficacy and safety of rituximab in the treatment of pemphigus vulgaris.