Last week we posted a blog about the risks of PML for patients taking Tysabri, based on news from the American Academy of Neurology (AAN) meetings which took place earlier this month. In the comments section, Chris asked that we check our facts and report back.
Well, once again, your commitment to the Life With MS Blog community has paid off.
I jotted off a quick e-mail to the Public Affairs department for Biogen/Idec and waited… and waited… and got nothing. Because, however, of the active participation of our community the conversation was noted and I got an e-mail asking if we needed any assistance directly from the senior manager for international public affairs.
I am not happy that I was wrong, but I am happy to know that we can get the correct information out to you today.
I had reported that Alfred Sandrock, MD, PhD, of Biogen/Idec, presented findings from the company’s study on progressive multifocal leukoencephalopathy (PML) in patients using Biogen/Idec’s MS drug, Tysabri. I was mistaken in my assessment of “immunosuppressive” (IS) therapy in the list of risk factors for PML.
Risk factors for PML include:
More than two years on Tysabri
Prior immunosuppressant therapy
Positive serology for JC virus infection
According to Biogen, immunosuppessants, in the context used by Dr Sandrock are limited as:
“A prior IS would be considered mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab, and chemotherapy (not otherwise specified).”
Not included, as you can see, are any of the other MS disease modifying therapies (DMT) or even corticosteroids like Solu-Medral or Prednisone — which is normally considered an IS drug, but not for the case of the PML warning.
The original press release that I received on the topic was incomplete and I apologize for the misunderstanding.
As a side note, I took advantage of the conversation to request more information on the companies rational in keeping the patent on the JC Virus assay test that I also mentioned in that same blog post. I’ll update you on that conversation as soon as it happens.
Once again, your voice was heard by the people who have the answers and I think we’ve cleared up the misunderstanding. Thank you all for your continued involvement in our community. It makes a big difference in the lives of so many!
Wishing you and your family the best of health