Sunday, 31 August 2014

Preliminary alemtuzumab survey results

When the results of a survey change the way you see the world; having progressive MS is like having a different disease. #MSBlog #MSResearch

"Last week I did a ClinicSpeak post on 'when to say no to alemtuzumab' and linked it to a survey. The preliminary results of the survey are quite surprising and a real eye-opener for me. Despite blogging on alemtuzumab for several years over 40% of respondents were not aware that alemtuzumab has yet to be shown to be effective in SPMS. I suspect many of the readers were shocked to find out that it may not alter the course of SPMS."

"It was reassuring though that the vast majority of you support a trial to test Alemtuzumab in SPMS and  that you don't think the risks of alemtuzumab outway the undefined benefits in this population, despite the Cambridge group suggesting the drug may not be effective in SPMS. I hope Genzyme staff take note of this."

"What I did find very startling that considering its risks of alemtuzumab that the majority of SPMSers would consider taking the drug on the chance of it possibly working in SPMS. I am sure this driven by the fact that we have no licensed therapies for non-relapsing SPMS. Some of the comments below reflect this."

"As I suspected the hype surrounding alemtuzumab treatment for RRMS has unfortunately created unrealistic expectations for SPMSers; this has been my personal observation in clinic and one of the reasons for doing the 'when to say no to alemtuzumab' post." 



Comments from the survey
  1. My biggest suggestions are to (1) show them the scientific study that shows it has no impact on SPMS and (2) provide them some hope in an alternative. This is why I am not sure if the risks outweight the benefits. If there are no effective treatment or the patient has failed other potential fixes, I think the patient has the right to make the call on whether to roll the dice and try alemtuzumab. In my view, the doctors job is to make clear to the patient the risks/benefits and prevent blatantly wrong treatment choices, but it is not to prevent a patient from taking a reasonable long shot treatment.
  2. Need to explain this post to MSers. 
  3. They need an alternative- maybe fingolimod?
  4. I attended a presentation by Professor Alastair Compston a few years ago and he was quite clear that Campath was only effective for the newly diagnosed. Apart from explaining the research, I don't see what else can be done.
  5. Sadly, dealing with desperate people is always going to be tricky.
  6. This sounds a bit vague, but I think that we all need a really good 'package of information' regarding expectations, treatment and goals for the progressive phase of MS. I have had RRMS for 11 years and know the day will come when I'm told it''s becoming progressive. The anxiety is already building. I've heard it's not necessarily going to be absolutely dreadful (I'm pretty good at the moment) but the whole subject seems to be studiously avoided, on the need-to-know basis - understandably. Isn't it time to blow it open? Break it down into manageable chunks, set out the meds for each bit of the picture? I reckon the hype around alemtuzemab is partly because of the vacuum of information. It needs to be put in the context of ongoing management. Something like 'What to expect/what we can do'. 
  7. Only to reiterate that no, or uncertain, benefits accrue to SPMSers from taking Alemtuzumab. It might help if symptomatic treatments like Sativex and Fampyra were more readily accessible. People get desperate because there is nothing available/accessible that helps them. At the same time they are being knocked by having to reapply for PIP, with the 20metre rule, and I have heard anecdotally that it is getting much more difficult to obtain a Blue Badge. For many people these two things make life a little easier and helps them stay in work [and pay tax] (ie able to afford the journey, park reasonably close by etc) and bearing in mind that you don't recover from MS it shouldn't be made MORE difficult to obtain these things as time goes on. I think MSers should be more militant, which I realise is a bit of a tall order!
  8. LDN, Sativex? A nicer NICE? The red pill or the blue pill?
  9. Neurologists need to be on the same page when using alemtuzumab. Patients are confused when there is no consensus.
  10. Show them the inclusion criteria and that the mean age in the alemtuzumab studies was less than 4 years - there risks are relatively high with unproven benefit. 
  11. Sorry, I really don't know. Better diagnosis of SPMS might help because lots of people feel in limbo, are they RRMS or SPMS. Some say it does not matter but if it defines what treatment you can have maybe the transition needs to be diagnosed and discussed (and patients actively monitored). You need to know what camp you are in and can then inform yourself about the situation.
  12. Otherwise it is just going to have to be continued discussions on these sites and MS Trust/society websites. Where do patients get their info from?
  13. Then we get to treating early before we get SPMS and are no longer eligible. I am up for a phase 3 trial for SPMS though!
  14. No. The research doesn't back up that it would be useful if have SPMS. I have relapsing remitting with no significant disability YET. But cannot get my neurologist to agree that it should be used first line - I would be extremely keen to consider it (aware there are significant risks) if it was shown to reduce disability progression. My impression of the research is it does reduce progression, but neurologist disagrees. 
  15. I was on the cusp, diagnosed 11 years with significant disease accumulation. I live in the US & traveled to Germany for Alemtuzumab April 2014. I have experienced a renaissance of remission. 
  16. I am alarmed by this article and conclusions of the neurologist. By his criteria I would not have qualified (11 years, disabling fatigue, unable to more more than a few hours a day, resigned primary career in medicine due to mental fog & large amounts of pain & spasticity). 
  17. I now have almost NONE of these symptoms & feel as if I don't 'have MS' excepts for the use of 3 tablets of muscle relaxers a day. I don't even use pain meds or anything for fatigue. These are all chronicled on the blog Lemtrada.blogspot.com
  18. MSers should have the option of going onto this therapy regardless of their type of disease. As there is no treatment for progressive MS taking a chance on the possibility of benefit it better than waiting to deteriorate. 
  19. No not really but can understand why people are so desperate for anything that will stop MS in its tracks Perhaps people underestimate the risks because there is not the associated PML with alemtuzumab so think anything else is worth the risk
  20. Show them the results of the trials and discuss the risks. Be clear that the evidence suggests that they are pointless risks. Forget the costs, that's for you to worry about. We do not want to hear that we can't have something because it's too expensive, we want to hear that it won't be good for us if we have to hear a no. 
  21. Tell the patient the bare truth of knowledge as it should be for them. Cut the nonsense. Do not allow neurologists who know very little re MS from being allowed to see MSers
  22. MSers and prescribe inappropriate treatment in a wholly wrong fashion.
  23. There are very many MSers putting up with very very second rate care if any!
CoI: multiple

6 comments:

  1. Great to read how lemtrada helped the commentor on the cusp of SPMS 11 years into MS

    ReplyDelete
  2. My confusion on this revolves around the concept of "therapeutic lag" that you often bring up.

    I thought you were of the opinion that this idea could be the reason why treatments of progressive MS haven't shown benefit in the trials? i.e. the trials weren't long enough, and if they had been longer they may have shown an alteration of disease course. I believe there was even some data to support this (I think it involved a much less effective treatment even)?

    Trials have failed to strongly support alemtuzumab in SPMS, but are you confident that were they appropriately designed? As i understand your therapeutic lag hypothesis, progression could well continue for a couple of years after treatments with alem (having been primed by previous inflammation) before then stabilising.

    If this is accurate - I can see why people would be keen to give it a shot. Particularly in the absence of any alternatives!

    ReplyDelete
    Replies
    1. Re: "My confusion on this revolves around the concept of "therapeutic lag" that you often bring up."

      Yes, I am strong advocate of the hypothesis and think it is a real phenomenon that has been observed in one PPMS study. I have aske Biogen-Idec and Novartis to look at their data on natalizumab and fingolimod, respectively, to see if it is there. However, it remains a hypothesis that needs to be rejected, or accepted, by doing clinical trials. We, or more correctly, I can't really recommend off-label prescribing based on a hypothesis. The harsh reality on the ground is that alemtuzumab does not have a license for SPMS.

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    2. Re: "Trials have failed to strongly support alemtuzumab in SPMS, but are you confident that were they appropriately designed?"

      There have been no randomised controlled trials so it is impossible to tell whether or not alemtuzumab can slow down SPMS. This is why trials are needed. When you look at the figure in the Coles et al. 2006 paper about a quarter of SPMSers seem to stabilize post alemtuzumab; this is more that one would expect from natural history studies.

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  3. Prof. G is cost the main issue here? If alemtuzumab was very cheap would you and other prescribe if for people with SPMS?

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    Replies
    1. Re: "If alemtuzumab was very cheap would you and other prescribe if for people with SPMS?"

      I agree cost is an issue, which is why NICE have restricted the drug for RRMS that is active. The NICE process is all about cost-effectiveness. I the drug was cheap would I prescribe it for progressive MS? I suspect not; it is all about the risks and benefits. How can we expose SPMSers to the risks of alemtuzumab without being confident about the benefits?

      Primum non nocere - "first, do no harm" - this is what I signed-up for when I graduated way back in 1987 as a doctor.

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