Rituximab (MabThera®, Rituxan®), a chimeric murine/human anti-CD20 monoclonal antibody administered by intravenous infusion, is indicated for the treatment of moderate to severe pemphigus vulgaris (PV), in combination with a tapering course of corticosteroids. Approval in the EU and USA was based on data for the subset of patients with newly-diagnosed, previously untreated PV participating in the randomized, controlled RITUX 3 study; rituximab plus short-course prednisone resulted in a > 3-fold higher rate of complete remission off prednisone therapy and a > 2-fold decrease in the rate of moderate/severe relapse compared with standard-dose prednisone in this patient subpopulation. In addition, rituximab plus short-term prednisone was steroid-sparing and resulted in fewer patients experiencing grade 3 or 4 corticosteroid-related adverse events compared with standard-dose prednisone. The adverse event profile of rituximab in patients with PV was consistent with that observed for the drug in other approved autoimmune disorders; no new safety concerns were identified. Notwithstanding there is some uncertainty over the optimum dosing schedule to achieve and maintain disease control, rituximab is a highly effective and generally well tolerated, steroid-sparing treatment for moderate to severe PV.
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During the peer review process, the manufacturer of rituximab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflicts of interest
James Frampton is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11307599.
The manuscript was reviewed by:K.T. Amber, Department of Dermatology, University of Illinois at Chicago, Chicago, IL, USA, D. Didona, Department of Dermatology and Allergology, Philipps University, Marburg, Germany, R. Maglie, Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy, S. Tavakolpour, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.
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Frampton, J.E. Rituximab: A Review in Pemphigus Vulgaris. Am J Clin Dermatol 21, 149–156 (2020). https://doi.org/10.1007/s40257-019-00497-9