Here is My Question:
I am a 32 year old female diagnosed with RRMS 16 years ago and have been on Tysabri for approximately 8 years with success. My JCV test came back with a first positive result in December 2014 and retested 4/18/15 with a titer of 2.71.
My neurologist wishes me to have a 3 month washout period, then begin intravenous steroids when my next Tysabri infusion would be “due” (continue monthly for 6 months) and ultimately change my treatment to Tecfidera.
I was initially treated with steroids, then Copaxone for 2.5 +years (average relapse rate of every 3-4 months), Avonex for 2.5+ years (same relapse rate and discontinued after two seizures). I was medication free for 2 years and then started Tysabri. My life has never been the same (in a good way)!
I am hesitant to go off of Tysabri and on Tecfidera for a few reasons:
My questions are as follows:
Considering this information and my questions – what guidance can you provide me?
Great questions. I only wish we had more data for better answers. Here is what we think we know:
Your options can be separated into three categories:
The safest option is to stop Tysabri for 3-6 months with monitoring MRI scans of the brain obtained before stopping, then at 4 months and 6 months after the last infusion. Tysabri take a good 3 months to wash out of your system. Since PML usually begins well before a person is symptomatic, you want to make sure there is no evidence of PML on your MRI before even stopping Tysabri; no one has developed PML more than 6 months after stopping Tysabri so this would be the safest time to start another therapy. Any clinical or MRI activity before 6 months would prompt early initiation of another therapy. At 6 months you could start any therapy including rituximab.
The most effective option for stopping Tysabri and preventing disease activity from returning would be to start a DMT immediately after stopping Tysabri (or usually within a month when it can be arranged) Options could include Aubagio, Gilenya, Tecfidera depending on a number of factors you can discuss with your doctor. Again, you should have an MRI before stopping Tysabri and then 4 and 6 months after stopping Tysabri to make sure there is no PML developing or rebound MS activity. Rituximab is a difficult option until we are sure there is no evidence of PML since it irreversibly decreases your B cell counts for up to 6 months after treatment. If you developed PML during this interval it could be difficult to treat.
The most effective option may be to increase the interval between Tysabri infusions to every 8 weeks and monitor for PML with MRI scans at least every 4 months. We use a very rapid protocol that does not include gadolinium unless new T2 or DWI hyper intensities develop.
To answer your last question, I think the CD20 agents like Rituximab and the other products in development are outstanding for MS. We have no idea if they are better than Tecfidera at this time, but that would be my bet.
Take this information to your MS specialist and see what he or she thinks. If you decide to just increase the interval between Tysabri infusions to every 8 weeks, make sure your MS specialist contacts Dr Ilya Kister at NYU. He has a large registry monitoring all the patients on this reduced dosing frequency.
Revere (Rip) Kinkel MD
Director of the Multiple Sclerosis Program
Professor of Clinical Neurosciences
University of California San Diego
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