Comparison of efficacy of Rituximab, standard rheumatoid arthritis protocol (2 grams) vs ultra-low dose (200 mg) in the management of Pemphigus: A Randomized Controlled Trial

Patients diagnosed with Pemphigus based on clinical features, Tzanck smear, Histopathological examination ± Direct Immunofluorescence findings will be included in the study. The participants will be divided into 2 groups A and B. Group A will receive Standard dose Rituximab, RA protocol (2 infusions of 1000 mg at 2 weeks apart) and Group B will receive ultra low Rituximab (2 infusions of 100 mg at 2 weeks apart). Efficacy and safety profile in two groups will be measured. Study will be approximately of 18 months. Research question is whether ultra-low dose Rituximab (200 mg) is efficacious in the management of Pemphigus. Aim of the study is to compare the efficacy and safety profile upon administration of Rituximab, RA Protocol (2000 mg) vs ultra low dose (200 mg). Our Primary Objective is to compare the efficacy between 2 groups based on Clinical (complete remission on minimal therapy, Time to complete remission) and Laboratory parameters (trends of peripheral blood B cell marker CD19 in patients). Our secondary objectives are to do comparison of relapse, safety profile and cost analysis between 2 groups. Patients diagnosed with Pemphigus based on clinical features, Tzanck smear, Histopathological examination ± Direct Immunofluorescence findings will be included in the study. Patients having Rituximab infusion within 9 months, Dexamethasone- Cyclophosphamide pulse therapy within 3 months, steroid sparing adjuvant immunosuppressants use within 4 weeks, paraneoplastic pemphigus, pregnancy or lactation, any active infections (viral hepatitis, HIV, TB, Sepsis), known hypersensitivity to any study molecule, cardiac arrythmias will be excluded from the study. We are expecting that Ultra-low dose Rituximab (2 infusions of 100 mg at 2 weeks apart) will provide good results.