By now you might have heard that two multiple sclerosis (MS) patients in Europe being treated with the drug Tysabri have come down with a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). One patient is recovering at home — the other remains hospitalized. We want you to be informed about this and to consider all the options available to you.
Background
PML is usually found in patients with concurrent, severe immune system suppression, such as terminal HIV/AIDS, or accompanying aggressive use of chemotherapeutic drugs in cancer or organ transplant treatment.
PML was first observed in three MS patients being treated with Tysabri following its initial FDA approval in 2004. Each of these patients had also used other immune modifying medications. The FDA withdrew Tysabri for almost two years, during which time no additional PML cases were observed. Tysabri was again made available in June 2006, with the stipulation that it could not be used in combination with other immune-modifying medications. Tysabri carries a “black box” warning — the FDA’s sternest warning — about PML risk. There are currently more than 30,000 MS patients worldwide receiving Tysabri.
The Providence Multiple Sclerosis Center is recommending that every patient receiving Tysabri be immediately notified of these adverse events. However, Providence Multiple Sclerosis Center is not recommending automatic discontinuation of Tysabri. Instead, this decision should be made on a patient-by-patient basis.
What you can do
Consideration of the clinical benefits of Tysabri, responses to prior medications, and available alternative therapies should all be taken into consideration in making a decision about continuing Tysabri therapy.
For our patients electing to continue Tysabri, we recommend they visit the Providence Multiple Sclerosis Center every three months. We would like to see patients immediately if they develop symptoms atypical for MS. In the next week the Providence Multiple Sclerosis Center will be providing guidelines for detecting and treating PML to physicians and nurses, and alerting all radiologists to the reappearance of PML in MS patients.
Providence Multiple Sclerosis Center will hold a forum later this month for patients to learn more about this news involving Tysabri. The forum will be held from 7 p.m. to 8:30 p.m., Friday, August 15 in Souther Auditorium at Providence St. Vincent Medical Center.
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