So many people are wondering about this in the MS world and with good reason...more and more people are trying Tysabri. I guess the big thing in my mind is...does Tysabri directly cause this rare brain infection or was it due to combining treatments? Do these patients have anything in common for them to react in this way? It seems to be such a promising drug otherwise. But yeah...the risk seems too high for me. Personally...I would not try it...I would be too frightened.
Great post...I hope you write more on this when you find out any more information.
I'm glad that you want to hear more, because I've got lots more on Tysabri. It just got to be too much to include in one post. More is to come.
The issue of monotherapy, versus combination therapies, is very interesting now. Recently the FDA did make an adjustment to the label to reflect the PML cases which occurred during Tysabri use alone.
My neurologist is more conservative and is pleased with the results I'm currently getting with Copaxone. So we're sticking to that for now.
Thanks for stopping by.
I know when they pulled tysabri out of the market the previous time that they found that using tysabri in combination of other approved ms drugs could cause this brain infection but there has been cases were no one was using other disease modifying drugs.....I had gotten this info from my ms neurologist when he wanted to put me on tysabri and I have refused.....I do know that the health care professional has to be certified or something like that to give tysabri that way they can spot the symptoms of pml when and if they arise....Myself I will continue to refuse this medication and take my chances with ms.
Lisa,
I have not taken Tysabri and probably won't in the future because the risks, although slim, are still big risks for my family. That being said, if my MS got worse, would we consider it and we might and as Mandy said, it would be nice to have that option given the high accolades it gets. I know many people who are taking the Tysabri and they swear by it - think it is the best thing since sliced bread
.
I heard Dr. Richert speak at a research update once. He is the exec VP of research and clinical programs for the MS Society up in NY. He said that he believes that we (MS Patients) are going to see a lot more drugs in the near future. However, all of the drugs will have serious side effects that we will all have to weigh before we decide on the drug. And as much as I would love to stop taking a shot for a pill, at least the ABCR's side effects aren't life threatening, annoying yes. There is one drug, Campath which has a side effect of giving people on it (2 out of 39 test patients - http://www.ncbi.nlm.nih.gov/pubmed/18283404) a Thyroid disease which is managed with other drugs. I saw him speak almost a year ago and he said then that another case of PML would surface even with the Black Label and then it did.
Right after it first came to market a few years back, I heard Dr. McFarland (the big cheese at NIH for MS - it is easier than writing his actual title) speak and he recommended people wait and see. And that was way before the PML news came out the first time. I agreed with him then. Part of me wishes I would have taken the wait and see with the other drugs, but alas I'm 10 years into taking them so I guess I missed that the boat on that one.
So my take is, let Tysabri stay but really warn people of the risks. I was really scared for my friend that was in the Tysabri study when the news of the first PML cases came out. He got tested - a LOT. But one thing that he said struck me. When I asked him if he would be walking in the Walk-MS that year, he said he wasn't sure if he'd be able to walk. I had only known him after he started the Tysabri and he was 100% functional motor skills wise. But he was scared that being off the Tysabri might make him go back to using a cane. And he is not the only one I know that has had such positive results from taking the drug. So if they are willing to accept the risks, they should be allowed to do so.
Kristin
Kristin, I agree that Tysabri should remain available to those who gain great benefits and who are willing to accept the risks.
There are so many patients who absolutely LOVE tysabri and who were quite vocal after these two PML cases minimizing the risk within the context of how many patients are using the drug. But it's not as easy as that.
I plan to talk more about this. But for now, tysabri is not a personal choice for me and my neurologist is not recommending it.
Hey, are you ready for the Challenge Walk? I hope that weather continues to be cool around these parts. I'll be thinkin' of you.
Hello all. I have been taking Tysabri for close to 2 years. I actually go for my 21st dose tomorrow. I think, like many of the people who have commented, that it definitely has to be up tot the patient if they want to take the medication. I was diagnosed in January of 2007 and Tysabri has been the only drug that I have been on. It was not an easy decision to make, but I decided to give it a try beause my condition was very poor and my neurologist recommended I try it. Since taking the drug I have been 98% better. I can walk again and have no dissy spells. This medication has been a blessing to me and I pray that I will stay well while on this medication. I plan on having children soon, so I will most likely be off the medication 3 months before trying to concieve. Hopefully no other PML cases will emerge. If so, I don't know if I will return to Tysabri. But I am afraid of returning to my prior condition.
Lisa, I've had MS for eight years amd have tried several treatments and combinations. I was put on Tysabri before it was taken off the market and have been taking now since last October. I have laready had a scare with PML before. A spinal tap proved that was not the case. My doctor has asked if I would like to continue the treatment with so many practioners removing the drug from their patients for a period of time. This is such an emotionally hard decision for me. I was taken out of work permanently this year due to my progressing disease, however, Tysabri is the only drug that has worked for me. If a patient has a wash-out period with Tysabri, that is, that do not cantinue the treatment for a period of time, does this significantly decrease the risks?
Hi Heather,
Sorry to hear that you've had a difficult year with disease progression. But it's good to hear the Tysabri did work for you when you've been on it.
About the "vacation" period which some neurologists are now recommending, I am not sure that there is hard evidence to support (or not support) that this would have an impact (good or bad) on the risk of PML or disease progression.
I did find a published study which had followed patients who used Tysabri for 30 months and then had discontinued for 14 months. What they found was that there was not a rebound of disease activity after the 14 months. So maybe this can be used to show that stopping Tysabri for a period of time does not cause the disease to begin progressing again in patients for whom Tysabri is effective.(?)
I'm not a medical professional so I'm just speculating here. And since I'm not a neurologist who treats MS patients, I've not received the announcements or bulletins which may be suggesting that patients on Tysabri take a "vacation" from medication after 18 months or so, then resume infusions.
I wish that I knew the answer to your question!!! It would be wonderful to know positively if taking a "vacation" from the infusions did reduce the (already small) risk of developing PML. Here is where we must trust our neurologists to know what the recommendations are and why each recommendation is made.
Lisa,
Biogen has a presentation on their website titled "Reaccelerating Tysabri". Part of the presentation looks at the issue of disease activity following stoppage of Tysabri. Disease activity doesn't rebound as you stated but it does return to pre-tysabri levels after a few months off Tysabri. Also, based on the low incidence of PML among the Tysabri patient population it would be extremely difficult to test whether a "drug holiday" would lower the risk of PML and by how much.
Chris
Thank you Chris for pointing me to the "Reaccelerating Tysabri" presentation. It was not easily located on the website so I googled it and found the pdf. I can appreciate the point which BiogenIdec is making in warning against a "tysabri holiday." However, the presentation does sound like a marketing powwow session designed to teach folks how to push Tysabri.
I ask you to reread my comment above. I did not state that there was a rebound effect. What I shared with the commenter was that I found one study which MIGHT be used to support the theory of a "drug holiday." The abstract can be found here. Note that this study was not associated with the drug companies in any way.
I remain objective and neutral on the topic of Tysabri due to the understanding that I do not make a perfect candidate. I have extensive use of Methotrexate for the treatment of rheumatoid arthritis which has been found to be an increased risk factor in the development of PML in Tysabri users. Please correct me if I'm wrong.
Also, this short blog is already much outdated since there have been further developments on the Tysabri/PML front since it was written. If you feel that a newer piece needs to be written, please contact the site producer about that. Topics must now be assigned to each writer.
Thank you for reading and thank you for sharing information about the "reaccelerating Tysabri" presentation. I learned something today.
Lisa,
Thanks for the reply. No need for a new topic. Yes the "Reaccelerating Tysabri" slides are marketing focused but the back portion contains the results of Tysabri stoppage after it was initially suspended. You can see the disease relapse activity start to return after 2 months of stoppage.
Sorry to hear that you hit the auto-immune disease megajackpot. The Methotrexate use is definitely a contraindication for Tysabri at this point.
Chris
Thanks for stating your findings. I have had MS for over 20 years now and have had amazing results with Tysabri. My dr just informed me he wanted me to go on a drug holiday. At this point I am 80% sure I will not take the holiday and continue trusting the Lord to improve my health through Tysabri.
After reading your imput - it helped give me a little more confidence.
Happy Mother's Day!
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I haven't had to use Tysabri yet. In my case, the possible benefits do not outweigh the risks. As with many things associated with MS, I would like to keep my options open. I want to see Tysabri remain available to people who have no alternatives and wish to take advantage of it. I hope it is there when and if I need it.
Absent overwhelming evidence of danger, with the guidance of a physician, and with full knowledge of the risks and benefits, patients should be allowed the right to decide to choose Tysabri... or not.
Hi Mandy,
I agree that Tysabri should remain available to patients who need and want it. And I believe that it will not be taken off the market under current circumstances.
But most importantly, I feel strongly that the risks should be well known in the neurology and patient communities. Report adverse effects, even if they do not end in PML or death.
Had you read about the two cases of melanoma associated with Tysabri use? Well, there's been a third patient in Connecticut who's developed melanoma. When we conversed, she didn't know yet the extent of the spread of cancer yet. I hope that she let's me know after she finds out.
I've got lots to more to share - stay turned.