FDA/CDC

FDA approves rituximab for treating pemphigus vulgaris


 

Rituximab (Rituxan) has been approved for the treatment of adults with moderate to severe pemphigus vulgaris, the manufacturer announced on June 7.

Rituximab is the first biologic approved for treating pemphigus vulgaris, Genentech, a member of the Roche group, stated in a press release announcing the approval.

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The prospective, multicenter, open-label, randomized trial, conducted in France, compared the rituximab product approved in the European Union, plus short-term corticosteroid therapy (1,000 mg rituximab administered intravenously at baseline and day 14, then 500 mg at 12 and 18 months, plus 0.5 mg/kg or 1.0 mg/kg per day of prednisone tapered over 3 or 6 months) to corticosteroid therapy alone (oral prednisone 1.0 or 1.5 mg/kg per day tapered over 12 or 18 months), in 90 patients newly diagnosed with moderate to severe pemphigus.

At 24 months, 89% of those in the rituximab group met the primary endpoint, complete remission off therapy at 24 months, compared with 34% of those on corticosteroids (P less than .0001), the investigators reported (Lancet. 2017 May 20;389[10083]:2031-40). Severe adverse events were more commonly reported in the prednisone-only group.


First approved in 1997, rituximab, an anti-CD20 monoclonal antibody, is approved for non-Hodgkin lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia, and granulomatosis with polyangiitis. The prescribing information includes a boxed warning about the risks of fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

The study published in the Lancet was funded by Roche, the French Ministry of Health, and the French Society of Dermatology.

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