Monday, 9 May 2016

Alemtuzumab 10 year phase II AAN Data

You have been asking about the ten year alemtuzumab data so here it is.

This is the AAN poster of the long term  follow up of the alemtuzumab phase II trial


Coles alemtuzumab camm223 10yr efficacy safety aan 2016_poster p3.053 from BartsMSBlog

So what does it say

Of the 106 who started about 90% completed 3 years follow up and most of those that entered the 10 year follow up remained however that was only 60 people. Did the others have a bad resut or were they so happy that they forgot they had MS and  didn't want to be reminded of this?

In those that were followed up a third never had more than the first set of injections about 45% had a third injection only

The annualised relapse rate was maintained at 0.1 across the ten years.

In the majority of people the EDSS improved or stabilised but at ten year the EDSS  improvement was about 0.1 better. Now if you were not on drug I expect that the EDSS would decline however,
it says to me do not accumulate damage before you start.

It says that the EDSS generally stabilises. So this says to me the damage is done and the natural repair mechanisms are not really that active by stopping inflammatory disease.

Thus athough there is some improvement, this is rather limited. This is what we see in the beasties, you stop more deficit but it dooes not turn back the clock. 

Therefore the damage you accumulate whilst deciding about whether to risk the big guns type of treatment i.e. highly effective treatments, is there to stay, so best to start treatment early.

I think this is a postive result.

However ,what they partly airbrush away, is the side effect issue. 

They say it is the same as already reported in other similar studies without telling us the real story or showing the real data. What are they hiding?   

They are not really hiding, but likewise they are not bringing the problem to the readers attention either. This is par for the course.

They say thyroid problems peak at three years but do they stop? 

We are not told. In the CARE-I/II data at the AAN the thyroid problem was over 40% at 5 years so it must have gone up. 

They say that serious adverse thyroid events occurred in less than 4% of patients each year , so more thyroid issues must be occuring past 5 years.. Does this mean 4% x 10 years so 40% of patients had serious thyriod problems or do they mean of those that have thyroid problems 4% were a problem requiring surgery etc. I think it is the latter

We will see when it is published but what will be missing from the publication, the bad  news I wonder?

Maybe if they could write papers with small print it would be there but some of this is so fine you can't see it they must have those bits printed in white so you can't see them:-).

COI: I have received research grant in the past from the makers of Alemtuzmab


18 comments:

  1. I can't really read the poster. Is there a more high resolution image available?

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    1. If you click here, you can download it at a pdf and then zoom in:
      https://www.slideshare.net/BartsMSBlog/coles-alemtuzumab-camm223-10yr-efficacy-safety-aan-2016poster-p3053

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  2. Thanks MD, I know this data is of great interest to many. I wonder if delegates were able to ask questions? They may have asked the questions you raised above, perhaps Prof G was there?

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  3. Any NEDA figures? Progression free is an important component, but I'm interested to know the figures that include MRI activity. I also can't read the poster.

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    1. Yes, and also rates of conversion to secondary progression. For me as a patient with early stage MS it's the biggest question of all - if it is proven that early treatment with alemtuzumab substantially delays or even prevents the onset of secondary progression, it will transform the RRMS battleground forever.

      This blog has previously reported that only a small minority of patients in the alemtuzumab ten-year cohort have become SPMS, fuelling optimism about early highly-effective treatment, but sadly I'm still not at all convinced that it's that simple. Sadly I think the 10-year data is not reliable for SPMS status.

      I'm believe some studies have concluded that SPMS onset typically occurs around 10 to 20 years after disease onset, so a single 10-year followup is still several years too early to be truly confident that alemtuzumab is really delaying or preventing SPMS.

      We also don't know what happened to the dropouts in the extension study. The best case scenario is that they were happy with the results and put MS behind them. That is a plausible explanation, but it how often do we see best case scenarios in the MS world? The worst case scenario is that their disease activity returned and they lost faith in the treatment and the study. Sadly, to me this sounds more realistic. How many of the dropouts converted to SPMS? I'd love/hate to know the answer.

      Will there be a 15-year follow up? I think SPMS status at 15 years post-treatment will be far more interesting data. If we saw similar results at that point, I would begin to believe that this drug can save my future.

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    2. Great questions Anonymous 1238 PM and 6:27 PM, MD could you answer or give your opinion if possible?

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  4. Thank you very much MD. Do you think that it would make sense to have another course of alemtuzumab a few years after the 2nd/3rd course for those patients whose EDSS deteriorates? Or does the deterioration imply that alemtuzumab is not the best DMT for them and they should change DMT?
    I acknowledge that your answer may not rely on data, but on scientific principles/hypotheses.

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    1. Not sure if you can "change" DMD once on an induction therapy.

      It sticks with you like shit on Velcro....

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    2. My MS nurse advised me you can. She mentioned Tysabri - not that I have any plans to try that. If Lemtrada does not work for me I will be pursuing HSCT.

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    3. You cannot literally "change" an induction therapy, as the effects of alemtuzumab will remain forever in the patients' bodies.

      I meant to start another DMT, whether it is Tysabri or something else; HSCT is still in clinical trials and carries many risks.

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    4. If your progression is being caused by the progressive elements of MS that DMTs don't target, then a change of DMTs would seem futile. If the progression is being caused by a relapse or a new lesion, then Lemtrada redosing is recommended. I don't think many have turned their mind to circumstances where it may be good to give another DMT rather than redose, other than in cases where lemtrada dosing reactions mean patients or docs don't want to redose. So it's possible but what's the effect - I know you're asking for answers on basis of scientific principles/hypotheses not data (and was interested to see if there was a response) - but it may be 'no idea' is the only answer available at the moment. Either way, I wish you all the best.

      Bojana

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  5. Is there any info on how this drug works on patients who already have graves disease?

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    1. I looked into this. I had Grave's treated by medication which seemed to resolve. Then, 15 years later I developed Hashimoto's. Best I could find was that some patients with preexisting thyroid issues have taken Lemtrada and thus far there is no evidence to suggest that they've done worse than anyone else. But the numbers are too small. I concluded that as I already have thyroid problems that I've less to lose in some respects, so I went for it. I'm only a couple of months in though, so too soon to say in my case.

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    2. Thanks for the info..best wishes for the future

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  6. Too bad there's no brain atrophy followup, neda % and % of progressors. Hope they collected data and pusblish it at some point.

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    1. it depnds if the data is good, if it is bad news I suspect it will be lost in a meeting abstract somewhere

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    2. MouseDoctor so no news is bad news in the context of some scientific research? lol

      Funny cos no news is good news in the context of MS lol.

      Bojana

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