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Rituximab: A Review in Pemphigus Vulgaris

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posted on 16.12.2019, 22:44 by James E. Frampton

Acknowledgements

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.


Compliance with Ethical Standards Funding

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 conficts of interest.


Additional information about this Adis Drug Review can be found here


Abstract

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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