Sunday, 19 October 2014

Taking A Break From Tysabri!

Over the past few months I have been thinking a lot about my Tysabri treatment. 
I started on the infusions on 30th June 2009 so I've been on it now for over five years, I've had around 65 infusions and to be perfectly honest that scares me........a lot! 
I know that I am monitored but that seems to vary depending on where in the country you are having the treatment, some are monitored a lot more than others and when one of the downsides of Tysabri is developing a potentially fatal brain infection called progressive multifocal leukoencephalopathy or PML, I actually don't think you can be monitored too closely! 
When Martin and I took the decision for me to start the infusions (and it was a joint decision) we didn't take it lightly. There had been known fatalities from people developing PML as a result of being on Tysabri infusions, none in the UK though which was promising! We had to weigh up the possible benefits with the possible downsides, as with any treatment you start, but this definitely felt like a heavier decision. The risks seemed to have jumped up in their seriousness and it wasn't a decision that we were going to rush in to. Having said that, there was a fair amount of reading material to look at and, of course, with the internet, there was endless information to be found. It seemed to be the drug that consultants were choosing, at that stage, and taking PML into account, it did appear that if you were on the infusions, you were going to be monitored and you were told what to look out for etc.
So after some thoughtful discussions, we decided that it was worth a try. In 2009 it looked as though three years was the maximum that people were on it for. I can't remember though whether that was the longest people had been on it or the longest you should be on it for. 

The idea behind Tysabri - - is that it is designed to slow down the progression of the MS in people with relapsing MS, it can cut down the amount of relapses someone has. It is given as an IV infusion once every four weeks. There is an increased risk of developing PML but they now know that the risk is higher if you have been exposed to the JC virus so they are able to do a blood test to check this for you. When I had my blood test done a couple of years ago I was negative for the virus but you should be tested regularly because the result can change. I know of people who tested negative for a handful of tests but then tested positive. If you test positive it doesn't mean you can't continue with Tysabri, it just means that the risk of developing PML is greater so you should talk it through with your consultant to see if that risk is worth taking. 

When I started my Tysabri infusions the first hurdle that I had to get over was being canulated. My veins, even at that time, were not good, but my main problem was pain. To stick a needle in my skin is like sticking a red hot poker in it. My skin is so hyper sensitive that the pain is horrendous. I'd had problems being canulated in the past but I hadn't needed it on a regular basis like I was going to be now. 
The infusion was every four weeks and the idea of going through this trauma on a regular basis did not fill me with joy. And it was horrible for the nurses too. They don't like inflicting pain on their patients really! 
There was a nurse on the unit I was at who I had originally met in 2002 when I first went there for all my diagnostic tests. She had held my hand throughout my first lumbar puncture and we hadn't forgotten each other! She was also the nurse that is a wizz at canulating people, especially those with difficult veins and whenever she was there she was the nurse that would canulate me but even for her it was a real struggle. 
It was because of all this that I ended up having a portacath (or TIVAD) implanted in my chest. It is a little device that they put into my chest. It has a tube that is connected to the main arterial vein in my neck and then I was sewn up and this device sits just under the skin. When I have my infusion the nurse has a needle with a tube attached to it, the needle is put into the device in my chest which is connected to the vein, the tube is hooked up to the saline bag with the Tysabri in it and the infusion goes directly into the vein through the needle. I still have magic cream put on before the needle goes in, because I am the ultimate baby.......and it still b****y hurts, but on the whole it is a much more satisfactory way of me receiving my infusion and that is how I have had it done ever since! The device itself can stay in my chest for long as there are no problems with it like infection. 
When it was first put in I was quite self conscious. I would wear tops that covered it but it didn't take long for me to forget that it was there! The funniest thing is when I show people that it's there and I get them to touch it, you can feel the device just under my skin and it tends to freak people out! ;-) 

Once I'd had the portacath fitted the infusions were a lot less stressful for me. The only issue I had then was that there were only a couple of nurses trained to use it. It is a little more complicated than a normal canulation so the nurses have to be trained and signed off on using the portacath. At the time I had mine fitted I was the only patient that was regularly on the unit that had one, so there was no one for anyone to practice on! I know that sounds bad but nurses need real people to hone their skills! By the time I had my latest infusion there were about half a dozen nurses that could use it though and I believe that there was one other patient with one fitted too! 

I cannot believe that I have been on Tysabri for over five years, that is incredible! But because I have been on it for so long it has got me thinking about it a lot over the past six months or so. There isn't a lot of information about the consequences of being on this treatment for a prolonged period of time and that bothers me slightly. So I wrote down my concerns and questions I had regarding whether I should take a break from the infusions and I emailed my consultant with those questions and fears. I know of friends who are on Tysabri and they know when they are ready for their next infusion. They know when the four weeks is coming to an end and they are due the treatment again because it affects them in such a way that they feel it but I have never experienced that. In fact in 2012 I virtually missed an infusion because of a holiday, I went for seven weeks in between infusions but I didn't feel any different. That has always been in the back of my mind and has made me wonder whether this drug is actually doing anything for me? I will say though that my MRI scans have been reasonably stable in the time I've been on the infusions, my consultant has always been happy with me being on it and I trust him wholeheartedly. 
I've just begun to question whether this is right for me though. It's one of those scenarios where I wish I had a clone so we could see how I would be now if I hadn't started on Tysabri at all....but there is no clone so we have to deal in the facts that we have now! 
I suggested to my consultant about having a break from my infusions for a number of reasons. 
1) I've been on it for over five years and we don't know the consequences of that. 
2) I don't feel any different from one infusion to the next so is there a chance that it's not doing anything for me? 
3) Immediately after the infusion it wipes me out, I have to write off the following two or three days because of how it makes me feel and I'm getting fed up of that now. 
4) If I have a break how long should it be for, should I start with three months and see how I'm doing after that? 
5) I know that I will be at risk of having a relapse if I stop this treatment but do you know how big that risk is? 
6) If I do have a relapse will I be able to go back to having Tysabri infusions? 
7) In a warped kind of way if I do have a relapse I will know that the Tysabri has been helping but if I don't have a relapse is it reasonable to assume that the infusions weren't helping me and so do I stop it altogether? 

As you can see I really have been giving this a lot of thought lately! 
My consultant was very good though and he answered a lot of my questions with the information that he has.
He agrees that a break could be a good idea, for the reasons I have stated. He has also said that yes I would be at risk of having a relapse but it is all hyperthetical, there is no way of knowing whether I will relapse or not or how bad the relapse would be if it did happen. Yes I can go back to having the treatment if I need too, I would just need an MRI to confirm a relapse. If I decide to go ahead with a break, his advice would be to go for six months to start with because it can take up to three months for the existing Tysabri to leave my body.
We recently had an appointment with our GP and we talked about the possibility of taking a break. I told her my reasons for wanting to do it and what my concerns were too, she felt that I was approaching it in exactly the right way and that providing I got answers from my consultant, she thought it was a good plan!

So here we are faced with another decision to make about my treatment! 
I know we have come a long way in giving the patient the right to make decisions about their own treatment and having been dealt the hand I have, I do appreciate that and I think it is a positive thing......but.......sometimes I wish the doctors would just make the decisions for me!
As with most things we do, Martin and I talked about it and came to a joint decision and I am going to take a break from the Tysabri. 
It does feel like a big thing that we are doing and there is no way of knowing whether it is the right thing or not but time will tell.
I had my last infusion on 28th August 2014 and because we had been on holiday I was a couple of weeks overdue for my treatment anyway so I haven't had that next one and my six month break is underway! I am obviously in contact with my consultant and our GP and I will be keeping them informed with anything that happens so I do feel that I am being supported, medically, with this here goes! ;-) 



  1. Hello, or should I say Ahoy there! Sorry not been in touch but all is manic when kids are at school. They have 2 weeks off now so will email too. You have made a difficult but brave and informed decision. I think you're brill and obviously haven't ruled it out altogether, it's a break, maybe for 6 months, maybe longer but YOU have made the decision. If your specialist told you that he wasn't prepared to prescribe it to you I'd imagine you'd be devastated but you're in control of your treatment. All fingers and numb toes crossed that this break goes as you wish. Love and Best Wishes, Nicky xxxxxx

  2. Hi Nicky, thanks for your words of support and for making me realise that yes I am in control! It's easy to lose sight of that when you are wrapped up in the situation itself. I thought I would forget about it but it's on my mind quite a bit, I guess it's still early days though eh?! I hope you are doing ok, have fun with the children over this two weeks, speak soon, love and hugs XxXxX

  3. I certainly understand why you might want a change, but I viewed with some concern the transition away from Tysabri. You might want to read the following from a highly regarded MS research center which emphasizes the need to replace Tysabri with an appropriate substitute and to have an adequate washout period. I debated whether to send this on but felt in the end it was important for me to do so. I wish you well.

    "The study below confirms the results of the TOFINGO study, MSBase and several smaller studies, which show that if you have a wash-out period when switching from natalizumab you are more likely to have a relapse than if you don't have a washout. Why? Natalizumab has a circulating half-life close to 2 weeks; the half-life describes the period of time it takes for the levels to drop by 50%. It therefore takes about 10-12 weeks (5-6 half lives) for natalizumab levels to drop to low enough levels to allow lymphocytes to start trafficking back into the brain and spinal cord. If these cells are autoimmune cells they will set-up an local inflammatory response and trigger a relapse. This process takes several weeks. This is why we see rebound disease activity (relapses or MRI activity) about 3-4 months after stopping natalizumab. Therefore it is not a good idea to stop natalizumab without starting another DMT to prevent this rebound. Unfortunately, interferon beta and GA have not proven to be very effective post-natalizumab. What about oral drugs? We don't have data yet on teriflunomide (Aubagio) or BG12 (Tecfidera). However, fingolimod has been studied and provided it is started with 8 weeks of stopping natalizumab it can prevent most of the rebound. The sooner you start it the better. At the Royal London Hospital we have adopted this practice for sometime now. If the switch is in a JCV positive MSers we do an MRI for new white matter lesions and lumbar puncture to analyse the spinal fluid for JCV DNA. If these test are clear the likelihood of asymptomatic PML is low and we start fingolimod. This typically occurs at around week 3 or 4 after the last infusion of natalizumab. As it takes about 6 weeks for fingolimod to take an effect by the time natalizumab is out of your system fingolimod is working."

    "If you are being switched from natalizumab to fingolimod and your neurologist wants to do a prolonged washout ask him/her why?"

    "What is most intriguing about stopping natalizumab is the rebound activity that is often very severe and greater than that what was seen prior to starting natalizumab. Why? I suggest you read my post from last year on this topic; it generated a lot of discussion about MS and its potential cause."

  4. Re: a washout period, the article seems to suggest there shouldn't be one.

  5. Thanks for this information, it was very eye opening! :-) XxXxX

  6. Hi- I am an MSer who has recently stopped Tysabri and would love to take a few months off. You were so kind to share your story the first time around, that I wanted to see if you could share any update. How long did you stay off of drug? Thanks!

    1. How are you feeling? I've been on Tysabri for almost 3 years jcv+ entire time.