Article date: December 2009
Rituximab (MabThera) in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying antirheumatic drugs including one or more tumour necrosis factor (TNF) inhibitor therapies. Rituximab is also indicated for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia in combination with chemotherapy.
In September 2009, a case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist. This case is the third case of PML reported in a patient with rheumatoid arthritis who was receiving rituximab. Cases of PML have also been reported in patients with other autoimmune diseases treated with rituximab.
A letter has been sent to relevant healthcare professionals to inform of this case and to remind that rituximab is not indicated for first-line treatment of rheumatoid arthritis.
Article citation: Drug Safety Update Dec 2009, vol 3 issue 5: 7b.