Friday, 10 November 2017

Ocrelizumab news: finally two eagles have landed

Landmark decision by the CHMP; ocrelizumab gets licensed for both relapsing and primary progressive MS.





For all those pwPPMS who have been waiting for a treatment for their disease. Your wait is almost over. After many anxious months, and against the opinion of many naysayers, the CHMP (Committe for Medicinal Products for Human Use) have greenlighted ocrelizumab for the treatment of PPMS in Europe. It is not quite the liberal license of other countries, but it is a start. 

"Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1). 

Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity (see section 5.1)."

The question I have for Roche is will they take up our #ThinkHand challenge and do a trial in people with more advanced MS, i.e. those who are in wheelchairs? 

I personally would like to thank all the pwMS who participated in both the relapsing (Opera 1 & 2) and primary progressive (Oratorio) trials; without you we wouldn't have gotten here. Progressive MS is now a tractable problem, what we now need is combination therapy trials. 




ProfG    

27 comments:

  1. How soon can I get treated with ocrelizumab?

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    1. It depends where you live...in Germany...maybe tomorrow

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    2. Good news and well done to all involved. Couple of questions: is it likely that Ocrelizumab will need to be taken every 6 months for life, therefore increasing the risks due to long- term immunosuppression? Could there be the possibility of serious rebound if the drug has to be stopped for any reason and white cell count too low to move onto another DMT?

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    3. Based on the label it will be taken every six months for life

      our working hypothesis of how ocrelizumab we would predict that it will not have to be taken that often for everyone. The unpublished phase ii extension data indicates this.

      I would not predict rebounds based on how it works you get slow repopulation of memory cells. ocrelizumab is B cell selective and are only about 5-20% of white cell count.

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    4. Ocrelizumab vs Cladribine? If your team at Barts were given the choice between these two drugs, I wonder which would be the preferred option? From what I've read, I think I would go for the latter based on its better safety profile and the crucial fact that it penetrates the CNS.

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  2. What a week for the field of MS and more importantly people with MS. It's as if we are living in a golden era. Thank you all for your hard work.

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    1. Getting a drug licensed is a massive job and involves a large team of people including pwMS. The real unsung heroes and heroines are the people with the disease. You can't ignore the impact that MS has on individual people's lives.

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    2. Confused as to why Cladribine is only licensed for people with highly active relapsing MS? It clearly has a better safety profile than Ocrelizumab but it doesn't appear to be as effective (just found your interesting post dated 2nd Feb 2017 titled 'Cladribine and end-organ damage').

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  3. No doubt the useless ‘accountants’ at NICE will say no or at best limit it to those with EDSS < 6.5 and have yet to grow facial hair!

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  4. Oh how happy this makes me feel :) Thank you all for your hard work keeping pwMS excited about what the future holds.

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  5. What are the cut-offs for "early" disease?

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    1. As I crossed the finish line of the NYC marathon I noticed a guy with 'Dr K' written across his shirt. I was too tired to speak to him.

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    2. Early PPMS = 10 years from symptom onset if your EDSS < 6.0 and 15 years if you are EDSS 6.0/6.5.

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  6. This is great news! Just what need for a Friday.

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  7. Please note the #ThinkHand challenge does not only apply to Roche. I am hoping Biogen reconsiders natalizumab, Merck cladribine, Novartis ofatumumab, Genzyme alemtuzumab, or a wealthy philanthropist to fund #Chariot-MS for DrK.

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    1. Feeling so grateful and more hopeful after this week's announcements. Thank you to all at Barts for your determination to help everyone with this monster disease. Please may I request a near future post comparing the safety/efficacy of Cladribine with Ocrelizumab, including info on how much they decrease brain volume loss? In fact, any recent data on the impact of All of the current DMTs on brain atrophy and disease progression (some sort of comparison chart maybe?) would be much appreciated. Best wishes to everyone.

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    2. Anon I want to echo the first two sentences of your post.
      Immediately pinged a text to a friend who knows someone recently diagnosed with PPMS and hope it helps lift her spirits and hopes for the future. Took pleasure in spreading the great news!
      The Blog is of such importance and benefit to me that it's beyond words!

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    3. Yes. This truly good news for patients in Europe. Will Roche offer Nice a similar deal AS Merck and MS patients get drug the drug immediatly? Also can barts team say with confidence that the natural course of disease has been altered for those treated early? And SPMS will soon become extinct? Not looking for guarantees in blood just your scientific opinion.

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    4. Anon 5:53;
      That would be great, although I thought Alemtuzumab was the only PIRT that’s released its brain atrophy data.

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  8. Well done to all involved :) in these exciting projects #Ocrevus #Mavenclad #ChariotMS #ThinkHand and success in #NYmarathon Aiden and DrK
    Happy Friday everyone :)

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  9. Very grateful for your work to improve lives of MS patients. You deserve recognition and should be on the New Year's Honours list in my opinion. Feel incredibly fortunate to live in this decade with the arrival of more effective treatments whilst also feeling sad for families whose loved ones have missed out and for MS patients who don't currently have access to these DMTs- let's hope that soon changes.

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  10. Don't mean to be a Debbie Downer here, but wouldn't the inclusion criteria for PPMS patients limit the use of Ocrevus to about 15% of the overall PPMS population? Isn't that the generally accepted number four progressive patients who display enhancing lesions? Of course, the number is probably higher for those with SPMS in its earlier stages.

    Interesting that the US gave blanket approval for progressive ms, whereas in Europe they put restrictions on which progressive patients can get the drug. Here's hoping that it works on all patients, regardless of inflammatory disease markers.

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    1. Hello TWK, you're probably about right there. Here in the UK we've yet to hear from the next round of hurdles to jump #NICE hope they'll be nice as they were with cladribine... Sorry, I know our NHS discount doesn't help things in the US....

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  11. Trustworthy overview: https://www.mstrust.org.uk/a-z/ocrelizumab-ocrevus

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  12. "Feeling so grateful and more hopeful after this week's announcements. Thank you to all at Barts for your determination to help everyone with this monster disease. Please may I request a near future post comparing the safety/efficacy of Cladribine with Ocrelizumab, including info on how much they decrease brain volume loss? In fact, any recent data on the impact of All of the current DMTs on brain atrophy and disease progression (some sort of comparison chart maybe?) would be much appreciated." I wanted to say I agree exactly with this poster. I am very, very grateful to the Barts team for all their work. Would really like to understand how these drugs compare and also what risks pwMS are taking if they have Clad straight after Fingolimod.

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