Wednesday, 8 November 2017

Will Biogen walk-the-talk and do another natalizumab SPMS trial?

At #MSParis207 I presented a new analysis of the data of the ASCEND trial (natalizumab in SPMS) that shows natalizumab is very effective in protecting upper limb function, and to a lesser extent lower limb function, in people with more advanced MS (majority needing walking aids). 



Will Biogen learn from this analysis and do an ASCEND-2 trial? If they cared about people with more advanced MS they would do this study. I also anticipate that in the future PML will not be a problem; we will have antivirals that will clear the body of JCV and the risk of PML as a complication of natalizumab treatment will become very, very, low. The latter is another reason for doing this study.

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12 comments:

  1. For folk with MS who just don't have time on their side to wait years for further trials and need to go on one of the more efficacious drugs now - from what data you have available so far, at this moment in time, which is the safest of the stronger DMT's: Alemtuzumab, Cladribine, Natalizumab or Ocrelizumab (hopefully the latter of this bunch will soon be licensed in the UK)?

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    1. Nobody really knows yet I guess. Scary thought that they might turn out to be very unsafe in the long term. Better idea of prognosis would certainly help when making such a difficult decision.

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    2. Recommend the drugs.com website which gives very detailed and helpful information about side effects of various drugs.

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    3. Anon 3:03 I agree with you. The whole treatment philosophy in MS is to treat early and effectively to prevent damage and preserve reserve capacity. This underpins our 'Brain Health: Time Matters in MS' policy document.

      http://www.msbrainhealth.org/

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  2. My gut tells me people would be safer and do better on rituximab.

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    1. Re: "..safer and do better on rituximab."

      Not sure about this. We need more data. May be the COMBAT-MS study will provide the necessary evidence.

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  3. Given there's no scientific test to prove you have RRMS or PPMS diagnosis and given PPMS diagnosis is very subjective. Why not give everyone a RRMS diagnosis? AS Barts and OTHERS of equal scientific credibility believe its tha same disease!. In addition you will not cause issues with pharma your main financial sponsors! As well as winning the ms community to your cause and the financial support that will come with it.

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    1. Here's example of revolutionary thinking by nice of all people!

      www.hospitalhealthcare.com/editors-pick/nhs-england-enters-commercial-agreement-allows-ms-patients-immediate-access-therapy

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    2. Re: "Why not give everyone a RRMS diagnosis?"

      This is happening in many countries. The incidence of PPMS is dropping precipitously. Why? Neurologists are diagnosing MS as relapsing and not primary progressive.

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    3. Thanks Dr Gavin for your reply. That is great news for people with PPMS.

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    4. "That is great news for people with PPMS."
      Not necessarily. Not when some people with PPMS end up with side effects from drugs which have a relatively poor risk/benefit ratio in their case.
      Watching Ibudilast.
      Of course there are fewer people categorised with PPMS if it's called something else.

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    5. surely no one should be diagnosed as secondary either. basically all drugs can benefit all stages of MS, but may take longer to do so which is never taken into account during trials.

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