Rituximab (MabThera®, Rituxan®), an intravenous infusion of a chimeric murine/human anti-CD20 monoclonal antibody, is indicated for the treatment of moderate to severe pemphigus vulgaris (PV), in conjunction with a tapering course of corticosteroids. Approval in the EU and the US was based on data from the randomised, controlled RITUX 3 study, which included a subset of patients with newly diagnosed, previously untreated PV; rituximab plus short-course prednisone resulted in a > 3-fold higher rate of complete remission off prednisone therapy and a > 2-fold lower rate of moderate/severe relapse compared to standard-dose prednisone. Furthermore, as compared to standard-dose prednisone, rituximab with short-term prednisone was steroid-sparing and resulted in fewer patients having grade 3 or 4 corticosteroid-related side effects.
The adverse event profile of rituximab in PV patients was comparable with that seen in other approved autoimmune diseases; no additional safety concerns were discovered. Despite some ambiguity about the best dosage schedule for achieving and maintaining disease control, rituximab is a very effective and typically well tolerated steroid-free therapy for moderate to severe PV.