Oh my.. I believe I have smoldering MS, altho when I talk to my doc about this I am looked at like I have 6 heads. Same if I mention EBV in correlation to MS.. But thats another story. My first question here is will this trial be available in the US or is this strictly for UK residents? I have worsening disability but cannot pin point actual relapses and the MRI's are showing worsening numbers of lesions as well as enlarging lesions. I am also 65 and have already been told I am well into SPMS, but they are keeping my offical record to say I am still RRMS. I assume this is for possibilities of certain DMT's that arent available to pwMS that are anything other than RRMS. Anyway, I would love to get more info on this trial and whether it will be open to US residents as well as UK (or whatever country). My doc is currently pushing Ocrevus less than a year coming off of Mayzent, which nearly killed me with the suppression of my immune system.I find this all very exciting!
Prof - interested in this comment 'I suspect in these pwMS, their immune systems get rid of, or at least control, the cause of MS without needing an exogenous treatment' is this potential inhibited by starting on a DMT, which supresses the immune system and its ability to get rid of the offending cause?
Also, have you observed any miracles yet in your sizomus trial? i know the results are down the track but wondered whether the patients were reporting changes even though you wouldnt know which arm of the trial they were on
I was initially accepted onto the Sizomus trial last year and I was so excited to be part of it. Unfortunately the lumbar puncture came back as negative. I did have a positive lumbar puncture result at diagnosis and Wafa contacted my hospital who confirmed this but sadly I could not continue with the trial. I did not know if was possible for the bands to disappear. Would this result prevent me from applying for the smouldering ms trial? Thanks
I am a healthy 60 year old female who was diagnosed with ppms over 20 years ago. I have never heard of smouldering ms but now I have it explains so much. I have had no relapses but my symptoms have SLOWLY progressed. I am on no medication. & would love to volunteer for the SIZOMUS study. It sound very exciting
Prof G - thanks for sharing and reminding us of this. The Kletzl et al paper you refer to states “risk reductions in 12-/24-week CDP was exposure-dependent”. Is 12/24 weeks enough and what sort of CDP do they mean? Also, should we be taking the Kletzl et al paper seriously as they are paid by Roche and some even own Roche stocks? My CD19 levels are still 0 at 10 months post Ocrelizumab infusion. I’m keen to halt/reduce any smouldering MS, so would having another Ocrevus infusion now have any benefit seeing as CD19 is currently 0?
I have to confess I've never heard of smouldering MS. I was only diagnosed in May 2022 and only started having symptoms about a year ago. I am on a DMT (Ocrevus) and I know that won't stop my current symptoms but these have got much worse very quickly. No new symptoms but old existing ones getting rapidly worse. I am not due to see my neurologist again until September 2024. Is this something the treatments you are trialling could help with?
Oh my #2 - this article blew my socks off - I've had MS for over 30 years and have never heard of "smoldering MS" - like Karin asked below will this trial be available in Canada? My diagnosis is SPMS and my symptoms have worsened considerably in the last two years. My recent MRI (one year ago) showed no new lesions. My neurologist at the MS Clinic has not suggested any DMT so I'm just plugging along - thank you for sharing this - can I share it with my FB Group, MS stands for Mindset Shift?
It would be interesting if we could get to try a combination approach between an established DMT and a BTKi, especially as it's looking like BTK inhibitors may not be as potent as high efficacy DMTs.
The title of the post brought hope, quickly killed by ‘only in Finland’. Why are MSers always in no man’s land when it comes to treating the real MS (EBV / smouldering MS)? Smouldering MS has been known about for some time, yet trials of therapies are always at the planning stage eg Octopus, early phase trials, or later phase trials which won’t report for 2-3 years (and if effective will have to go through long lead times for licensing). When will MSers actually have a pill in their hand which addresses smouldering MS? 2030?
Hi Prof G, I’ve completed the survey. It didn’t ask for my name / details so I assume it’s just collecting general info & not looking for individuals to register for it? Is that right?
For EBV treatment in this post you mention BTKi and Ixazomib. Will you still be investigating all the therapeutics targeting EBV that you discussed in this earlier post?
Prof G this multi-modal treatment approach to MS treatment is music to my ears, reminiscent of The Berlin Protocol in Germany. There is also a trial platform up and running for testing multiple therapies at once that you could look at for implementation ideas.
HEALEY ALS Platform Trial at Mass General
Borrowing from successes in cancer drug development, the Sean M. Healey & AMG Center for ALS at Mass General, in partnership with Tackle ALS, are leading the first Platform Trial initiative for ALS. Traditionally, each trial evaluates only one drug at a time, and requires lengthy start-up and execution times. Platform trials, instead, are trials where multiple drugs are tested at the same time, using specialized statistical tools. New regimens (drugs) can be added as they become available thereby decreasing or eliminating the gap in time from identification of a rationale therapy to testing. Thus, the focus is on the disease, rather than any individual experimental agent, and the platform remains open long-term until successful cures are found. The HEALEY ALS Platform Trial will test multiple promising experimental therapeutics using an efficient and informative early-phase design with increased access for people with ALS.
Oh my.. I believe I have smoldering MS, altho when I talk to my doc about this I am looked at like I have 6 heads. Same if I mention EBV in correlation to MS.. But thats another story. My first question here is will this trial be available in the US or is this strictly for UK residents? I have worsening disability but cannot pin point actual relapses and the MRI's are showing worsening numbers of lesions as well as enlarging lesions. I am also 65 and have already been told I am well into SPMS, but they are keeping my offical record to say I am still RRMS. I assume this is for possibilities of certain DMT's that arent available to pwMS that are anything other than RRMS. Anyway, I would love to get more info on this trial and whether it will be open to US residents as well as UK (or whatever country). My doc is currently pushing Ocrevus less than a year coming off of Mayzent, which nearly killed me with the suppression of my immune system.I find this all very exciting!
Prof - interested in this comment 'I suspect in these pwMS, their immune systems get rid of, or at least control, the cause of MS without needing an exogenous treatment' is this potential inhibited by starting on a DMT, which supresses the immune system and its ability to get rid of the offending cause?
Also, have you observed any miracles yet in your sizomus trial? i know the results are down the track but wondered whether the patients were reporting changes even though you wouldnt know which arm of the trial they were on
I was initially accepted onto the Sizomus trial last year and I was so excited to be part of it. Unfortunately the lumbar puncture came back as negative. I did have a positive lumbar puncture result at diagnosis and Wafa contacted my hospital who confirmed this but sadly I could not continue with the trial. I did not know if was possible for the bands to disappear. Would this result prevent me from applying for the smouldering ms trial? Thanks
I am a healthy 60 year old female who was diagnosed with ppms over 20 years ago. I have never heard of smouldering ms but now I have it explains so much. I have had no relapses but my symptoms have SLOWLY progressed. I am on no medication. & would love to volunteer for the SIZOMUS study. It sound very exciting
I am too old
Do you see these BTK inhibitors being a replacement or an add on to existing MS DMT?
Prof G - thanks for sharing and reminding us of this. The Kletzl et al paper you refer to states “risk reductions in 12-/24-week CDP was exposure-dependent”. Is 12/24 weeks enough and what sort of CDP do they mean? Also, should we be taking the Kletzl et al paper seriously as they are paid by Roche and some even own Roche stocks? My CD19 levels are still 0 at 10 months post Ocrelizumab infusion. I’m keen to halt/reduce any smouldering MS, so would having another Ocrevus infusion now have any benefit seeing as CD19 is currently 0?
I have to confess I've never heard of smouldering MS. I was only diagnosed in May 2022 and only started having symptoms about a year ago. I am on a DMT (Ocrevus) and I know that won't stop my current symptoms but these have got much worse very quickly. No new symptoms but old existing ones getting rapidly worse. I am not due to see my neurologist again until September 2024. Is this something the treatments you are trialling could help with?
Oh my #2 - this article blew my socks off - I've had MS for over 30 years and have never heard of "smoldering MS" - like Karin asked below will this trial be available in Canada? My diagnosis is SPMS and my symptoms have worsened considerably in the last two years. My recent MRI (one year ago) showed no new lesions. My neurologist at the MS Clinic has not suggested any DMT so I'm just plugging along - thank you for sharing this - can I share it with my FB Group, MS stands for Mindset Shift?
I filled in the form; I would absolutely sign up for the trial if they do one in the UK.
It would be interesting if we could get to try a combination approach between an established DMT and a BTKi, especially as it's looking like BTK inhibitors may not be as potent as high efficacy DMTs.
Is this feasible? Is there interest in it?
The title of the post brought hope, quickly killed by ‘only in Finland’. Why are MSers always in no man’s land when it comes to treating the real MS (EBV / smouldering MS)? Smouldering MS has been known about for some time, yet trials of therapies are always at the planning stage eg Octopus, early phase trials, or later phase trials which won’t report for 2-3 years (and if effective will have to go through long lead times for licensing). When will MSers actually have a pill in their hand which addresses smouldering MS? 2030?
Please can you consider me for theAHSCT trial ?
Hi Prof G, I’ve completed the survey. It didn’t ask for my name / details so I assume it’s just collecting general info & not looking for individuals to register for it? Is that right?
For EBV treatment in this post you mention BTKi and Ixazomib. Will you still be investigating all the therapeutics targeting EBV that you discussed in this earlier post?
EBV immunotherapy for MS: glofitamab induction
https://gavingiovannoni.substack.com/p/ebv-immunotherapy-for-ms-glofitamab#details
Prof G this multi-modal treatment approach to MS treatment is music to my ears, reminiscent of The Berlin Protocol in Germany. There is also a trial platform up and running for testing multiple therapies at once that you could look at for implementation ideas.
HEALEY ALS Platform Trial at Mass General
Borrowing from successes in cancer drug development, the Sean M. Healey & AMG Center for ALS at Mass General, in partnership with Tackle ALS, are leading the first Platform Trial initiative for ALS. Traditionally, each trial evaluates only one drug at a time, and requires lengthy start-up and execution times. Platform trials, instead, are trials where multiple drugs are tested at the same time, using specialized statistical tools. New regimens (drugs) can be added as they become available thereby decreasing or eliminating the gap in time from identification of a rationale therapy to testing. Thus, the focus is on the disease, rather than any individual experimental agent, and the platform remains open long-term until successful cures are found. The HEALEY ALS Platform Trial will test multiple promising experimental therapeutics using an efficient and informative early-phase design with increased access for people with ALS.
https://www.massgeneral.org/neurology/als/research/about-platform-trial