Third Case of Rare Brain Infection Found in Rituxan User, FDA Says

A third patient taking the drug Rituxan for rheumatoid arthritis has been diagnosed with a rare but deadly brain infection called progressive multifocal leukoencephalopathy (PML), drug maker Genentech and the Food Drug Administration said today.

It is the first PML case in which a patient with rheumatoid arthritis was taking Rituxan but had not previously taken a TNF antagonist, according to the FDA alert. Researchers have already said that patients treated with Rituxan for rheumatoid arthritis are at increased risks of developing PML.

“(Previously), PML has been reported in patients with rheumatoid arthritis, including those treated with other immunosuppressive medications in the absence of Rituxan,” the FDA said.

Rituxan (known generically as rituximab) is approved for treating rheumatoid arthritis and Non-Hodgkin’s Lymphoma in certain patients. In rheumatoid arthritis sufferers, the drug is used in combination with methotrexate to reduce symptoms and slow the progression of structural damage in adult patients with moderately-to severely- active rheumatoid arthritis who have had not responded sufficiently to one or more TNF-antagonist therapies, Genentech says.

Woman, 73, is Latest Rituxan PML Victim

The new case of PML linked to Rituxan was reported in a 73-year-old woman who was diagnosed with seronegative rheumatoid arthritis three years ago, officials said.

Two previous deaths caused by PML were reported in patients with rheumatoid arthritis treated with Rituxan. They included a 51-year-old woman and a 73-year-old woman with possible risk factors for the development of PML, including oropharyngeal malignancy treated with chemotherapy and radiation therapy and/or long standing lymphopenia prior to and during Rituxan treatment, the FDA said.

Doctors Cautioned About Rituxan Use

In light of the newly reported case of PML, the agency has sent a “Dear Doctor” letter to healthcare professionals to inform them and advise them on how to proceed in treating patients with the drug.

Doctors should consider PML in any patient being treated with Rituxan when the patient shows new onset neurologic manifestations, the FDA and Genentech said. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated to rule out possible problems.

PML is still considered rare in patients with rheumatoid arthritis receiving Rituxan, with just three reports of the disease in approximately 100,000 rheumatoid arthritis patients given the drug, the FDA said.

“However, the information to date suggests that patients with (rheumatoid arthritis) who receive Rituxan have an increased risk of PML,” the agency said in announcing the third PML case.

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