A Dear Healthcare Professional letter to physicians about important information concerning safety of the medicinal product MabThera (rituximab) in treatment of patients with rheumatoid arthritis
09.11.2009
Roche d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices, on 9 November 2009, sent a Dear Healthcare Professional letter to prescribing physicians about MabThera (rituximab) and progressive multifocal leukoencephalopathy (PML) in treatment of patients with rheumatoid arthritis (RA).
MabThera (rituximab) is a monoclonal antibody representing glycosylated immunoglobulin, and in combination with methotrexate, it is indicated for treatment of adult patients with a severe form of active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs, including one or more tumour necrosis factor (TNF) inhibitor therapies.
A fatal PML case has been reported in a patient who had previously not been treated with methotrexate or TNF antagonists. Overall, it is the third case of PML in RA patients treated with MabThera. PML cases have also been reported in patients treated with MabThera who suffer from other autoimmune diseases.
Prescribers have to bear in mind that the PML cases described relate to patients who did not have any other risk factor apart from treatment with MabThera. Therefore, it should be once again emphasised that MabThera is not indicated for the first-line treatment of rheumatoid arthritis.
Physicians should be alert to first symptoms and signs suggestive of PML. These include visual disturbances, motor dysfunction, and cognition impairment usually associated with clumsiness, blindness, marked weakness including hemiparesis and behavioural changes. Additional signs include sensory deficits, vertigo and convulsions. If a patient develops these symptoms, MabThera must be discontinued until the diagnosis of PML is excluded. Consultation with a neurological specialist is recommended. The clinician should determine whether the symptoms are indicative of neurological dysfunction, and if so, whether they are suggestive of PML. If any doubt exists, there should be further evaluation that may include MRI scan, lumbar puncture to test for JC viral DNA in Cerebrospinal fluid and repeat neurological assessment.
The Agency for Medicinal Products and Medical Devices will continue to monitor the safety of rituximab. Prescribing physicians will be receiving patient cards within the risk minimisation scheme.
The full text of the letter may be found below:
"A Dear Healthcare Professional letter to physicians on rituximab (MabThera) and progressive multifocal leukoencephalophathy (PML) in treatment of patients with rheumatoid arthritis (RA)"
