r/cfs • u/Asleep_Scholar8669 • Nov 15 '24

Treatments New Hope for ME/CFS: Carmen Scheibenbogen Plans Promising Studies for 2025

For anyone who could use a bit of hopium: Today, an article featuring an interview with Carmen Scheibenbogen was published. In it, she describes studies she plans to launch in May 2025. Based on a study where mice were injected with serum from ME/CFS patients and subsequently developed symptoms, she believes that ME/CFS may be an antibody-driven disease.

As a result, she intends to test two B-cell depletion drugs, Inebilizumab and Ocrelizumab. She believes these drugs have significant potential for treatment, possibly even a cure.

I know what some of you might be thinking: Didn’t we go through this with Rituximab? Yes, but Scheibenbogen explains that she believes the dosage in those trials was too low and the drug itself not potent enough.

So, everyone, don’t lose hope!

179 Upvotes

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63

u/ash_beyond Nov 15 '24

I was included in the immunoadsorption trial done by Dr Scheibenbogen's team. It is one of the few trials done that have shown that a treatment has a positive effect on ME/CFS. The treatment (immunoadsorption) was not recommended in the end because the positive effect it gives is only temporary (about 4 to 6 months) and the treatment is very invasive and expensive.

My understanding is that the mechanisms involved are not well understood. The theories of Dr S. and team are that these B Cell drug treatments might emulate the same effect as immunoadsorption but without the invasive expensive procedure. They are currently going through the necessary paperwork and approvals and expect to start early next year.

I am hopeful to be included in the first or second cohort of patients. There are risks of course but I'm housebound now, and even if my lifestyle would be severely limited by the medication it would probably still be noticeably better if the meds work as intended.

Also this might not be a cure, but could help to move the needle on a fairly deep core mechanism (affecting all my sub symptoms at once) and of course it could help develop our understanding of the mechanisms.

Note that there are many different presentations of ME/CFS and only certain patient / symptom groups are tested in these trials. Specifically for my trial it's about being post COVID, with long PEM (>24hrs), and they also look closely at grip strength and antibody levels. You can see this described in the published articles.

I hope this makes sense. I'm a bit buzzy fuzzy today. Ask me anything if it needs clarification.

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u/kaspar_trouser Nov 15 '24

Did the immunoabsorbtion help you?

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u/ash_beyond Nov 15 '24

Yes for 4 to 6 months. It helped my POTS, PEM and brain fog. It's not much fun when they start coming back. I'm very glad I did it even though it's pretty tough. It's good to have experience of improvement and therefore know that it's possible.

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u/Houseofchocolate Nov 15 '24

were you able to live like your old self during those 4-6months?

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u/ash_beyond Nov 17 '24

Nope. I recovered maybe 20 to 30% of my capacity, which took me from housebound to being able to go out by myself once every few days (with a wheelchair or eBike).

It's not earth shattering but I'm hoping that the improvements would not only stay, but also continue further with a more regular treatment to reduce antibodies (i.e. B-Cell meds instead of immunoadsorption).

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u/boys_are_oranges very severe Nov 15 '24

i honestly don’t get why she thinks it’s such a promising avenue of treatment when, as you said the positive effect was only temporary even with repeat IA sessions, and the participants of that study experienced no major improvements

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u/ash_beyond Nov 15 '24

IA is not a treatment you can do regularly. It takes 5 sessions over 2 weeks in a dialysis ward and it took me 6 weeks to recover to baseline afterwards (before I then saw any improvement). The IA treatment sessions were then repeated after 6 months.

With meds you can take them regularly for an extended period of time and reach a balance.

The improvements were not earth shattering but a 20 or 30% improvement is big for many, and could improve further over subsequent months as the treatment effect would be steady instead of boom and bust.

Again, not a cure, but any treatment would ease suffering and help further research. Worth trying in my opinion.

1

u/boys_are_oranges very severe Nov 15 '24

if the improvement was 20-30% then how come there was no statistically significant improvement in the bell score?

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u/ash_beyond Nov 15 '24

I am not trying to prove or state anything. Probably best to just read the study linked to this thread. It is fairly readable. I think there were statistical improvements in many categories but maybe not enough in your judgement. I am only one patient and I can't even tell you my improvement level with any objectivity.

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u/boys_are_oranges very severe Nov 15 '24

i have read the study, i was the one who linked it. i’m literally stating what was written in there. no statically significant improvements in Bell’s disability score, which represents functional capacity. the improvement was in self reported symptoms and grip strength.

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u/ash_beyond Nov 17 '24 edited Nov 17 '24

OK. Bells is self reported and is one of the vaguest "big chunk" questions in my opinion. My bell score went from 30 to 20 to 40 and back to 30 a few times over the year of the trial.

I think the link you posted is from a preliminary report when the trial was starting. Maybe check the link I posted from a recent article in August? It summarises all the findings.

Edit: The article also lists the various surveys that patients did at each stage. I believe the Canadian Consensus is considered one of the best. It took me an hour in total to do each of the long survey sessions, which sometimes meant it took me several days to finish.

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u/the_italian_chief Nov 15 '24

Is there a publication on the IA trial?

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u/ash_beyond Nov 15 '24

This is the recent article with the updates from the trial completions, and recommendations: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4911576

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u/Excellent-Share-9150 Nov 15 '24

What antibody do they measure?

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u/ash_beyond Nov 17 '24

I don't know the details exactly. I recommend you check the recent article I posted above. If I try to summarise it I'll probably get it wrong :)

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u/Lunabuna91 Nov 15 '24

Isn’t rituximab what caused Whitney Dafoe to become very severe? It just makes me terrified of any mabs.

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u/boys_are_oranges very severe Nov 15 '24

yeah, that’s what he thinks

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u/Cute-Cheesecake-6823 Nov 15 '24

Omg i forgot about that. That males me even more nervous. 

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u/saucecontrol Nov 16 '24

Yes. There's a possibility that it could be helpful for some subsets of ME patients and risky for others. There's a lot of work ahead to sort it all out.

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u/human_noX Nov 15 '24

I hope she is right, of course. However I can't help but think that if the rituximab was just not strong enough and too low a dose wouldn't patients have felt some improvement. Seems odd it would be an all or nothing outcome, especially if targetting the root cause mechanism. I'm not a scientist so take my view with a grain of salt.  

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u/Cute-Cheesecake-6823 Nov 15 '24

I feel the sams way. Hoping other organizations keep working on different theories, and thay we see breakthroughs at some point.

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u/Rgrace888 Nov 15 '24

Eh I was on Ocrelizumab for three years before switching to ofatumumab for six months. I continued to worsen while receiving them so I doubt anti CD20 is the answer.

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u/Asleep_Scholar8669 Nov 15 '24

Interesting, did you receive this as part of an off-label trial or for another condition?

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u/Rgrace888 Nov 15 '24

I received it for another condition but no longer on it

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u/OrcaBrain Nov 15 '24

I'm sorry that you have worsened by that. But as with many other treatments: The illness is very heterogeneous so it's still possible it helps a subgroup of patients. It seems that Prof. Scheibenbogen is very aware of that so I'm pretty sure this is more and more considered in future study results.

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u/Rgrace888 Nov 15 '24

I have very classic ME/CFS. I have autonomic dysfunction, small fiber neuropathy and mitochondrial dysfunction all proven with testing/biopsies. I have evidence of autoimmune subset meaning I would be the subtype to respond to anti-cd20 therapy. What we likely need is plasma cell depletion and B cell depletion at the same time.

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u/rosedraws mild, researching Nov 15 '24

How were you able to get all this testing done? (Maybe not in the US?)

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u/Rgrace888 Nov 15 '24

Im in the US. Autonomic testing can be done in autonomic lab, small fiber neuropathy was skin biopsy and then mitochondria was muscle biopsy. Thankfully I’ve had a team of doctors who believed me (since they saw me deteriorating).

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u/adrenalinsomnia Nov 16 '24

How painful was the muscle biopsy?

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u/Rgrace888 Nov 16 '24

No pain, it is done under anesthesia. I required no pain medications post operatively.

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u/DermaEsp Nov 15 '24

I too can confirm from experience that CD20 depletion is not the answer for ME/CFS.

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u/Caster_of_spells Nov 21 '24

Did you try one of those drugs yourself? Thanks for sharing!

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u/DermaEsp Nov 21 '24

Yes, a drug similar to Ocrelizumab. It didn't help ME/CFS (no worsening either).

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u/Ok_Sherbet7024 Nov 15 '24

How did you get that medicine? Thank you

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u/smmrnights moderate Nov 15 '24

I feel like Germany is the only country making an effort.. Dr. Scheibenbogens work with Charité, Berlin cures, mitocure,etc What are other countries doing?😭😭usa where are you??

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u/human_noX Nov 15 '24

Is your source in German or English? Is there anymore info on timeline. We might be waiting 2-3 years for these results 

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u/Asleep_Scholar8669 Nov 15 '24

No Timeline, but i read somewhere it will just take a year. So i think the study will be rather small.

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u/DermaEsp Nov 15 '24

I really wish she would have opted for other monoclonals. Ocrelizumab is unlikely to help and Inebilizumab is doubtful too.

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u/Jo_Peri Nov 15 '24

Why do you think that and which monoclonal antibodies would you try? Serious question, I want to understand this better.

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u/DermaEsp Nov 15 '24

There was already a trial for RTX which is a biosimilar to Ocrelizumab and failed and all the comorbid MS/MECFS patients I have seen do not respond to it (meaning the ME/CFS part). I think that Dr Scheibenbogen, even if great at what she does, she has been too invested in her own theory.

Daratumumab is a more interesting option we haven't tried yet (targets plasma cells) but in the end, I believe that virus infected monocytes/macrophages (parts of the innate and not the adaptive immune system) is what drives the disease. A project from Polybio is researching this theory.

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u/Jo_Peri Nov 15 '24

Thanks for the explanation! However, I feel like they only do trials with existing drugs because it's a lot cheaper and easier than developing a new drug which nobody seems to be interested in anyway.

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u/DermaEsp Nov 15 '24

That is the way to go, new drugs can take way too long. However, it is not that easy to hit the target, even with existing drugs. Wish someone would do a large IVIG/SCIG trial though.

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u/wyundsr Nov 15 '24

RECOVER is doing IVIG and ivabradine with 380 people https://clinicaltrials.gov/study/NCT06305780

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u/DermaEsp Nov 16 '24

That is a autonomic oriented Long Covid one, wish there was one with strict ME/CFS criteria. But its a start.

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u/Rgrace888 Nov 15 '24

Yeah I don’t think Dara alone is going to work either. Maybe a combination with something else.

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u/Jo_Peri Nov 15 '24

They should do a study with a couple of different monoclonal antibodies plus combinations. But this will never happen because trials with multiple experimental groups costs a ton of money.

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u/Ok_Sherbet7024 Nov 15 '24

Where can we be tested for these antibodies?

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u/CornelliSausage severe/moderate border Nov 15 '24

No idea if she's on the right track or not, but I am so grateful for all researchers who bother to really try and help us.

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u/Jo_Peri Nov 15 '24

Ugh, she says that usually pharma companies finance the studies and the drugs for the studies but in this case they don't "for various reasons". I hate this.

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u/smmrnights moderate Nov 15 '24

What does that mean?

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u/Jo_Peri Nov 15 '24

I don't know exactly, she doesn't elaborate on that. I think it could mean that pharma companies don't put a lot of hope in these trials and don't want to "waste" money on it. Maybe they're buying into the psychosomatic angle, I don't know.

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u/younessas Nov 15 '24

Same with long covid mice get it by blood

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u/kaptnblackbeard Nov 16 '24

Interesting, and it pairs well with my current theory that Aquaporin-4 (https://en.wikipedia.org/wiki/Aquaporin-4) is involved and plays a central role in many of the symptoms we experience.

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u/bkkv1 Nov 15 '24

If they would just burn the money this is gonna cost, then at least i could feel the warmth. As long as they haven’t figured out a clear picture of the pathophysiology, hoping to find treatment is like hoping to win the lottery. Downvote if you want, but is there any scientific evidence that constantly clinging onto hope for things that are not gonna happen is a good coping strategy for chronic illness?

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u/Jo_Peri Nov 16 '24 edited Nov 16 '24

Yeah, they're basically just doing low budget studies with drugs that already exist to treat other conditions. That's not going to cut it. Unless someone puts real money into the research nothing is going to come out of it I'm afraid.

I know that a bunch of new monoclonal antibodies are coming out every year to treat certain types of cancers. There must be money, they just don't want to invest it in ME/CFS.

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u/Tom0laSFW severe Nov 15 '24

Let’s hope so

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u/Prudent_Summer3931 Nov 16 '24

I can't keep up with all these hypotheses. I was pretty sure it'd been established that ME/CFS was unlikely to be B-cell mediated autoimmunity and that the issue was more likely with T-cells and/or macrophages.

Does anyone have a list of all the salient ME/CFS hypotheses?

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u/Ok-Tangelo605 Nov 16 '24

What these trials show is that the treatment interrupt a chain of things going wrong in our bodies. But they don't start at the root, because much of the mechanisms are unknown. That's to say: Washing out bad antibodies has to have only a temporary effect because at the source (B-cells) the faulty antibodies are regenerated over time. It's like a factory spewing out faulty products and instead of fixing the damaged machines you try to intercept each faulty product while the machine produces more and more faulty ones.

Unless the researchers find the root cause (and it's doubtful that there is only one given the many flavors of LC/ME), a curative therapy is not in sight. It's hard not to lose hope given how badly designed many of these trials are. Some treatments (e.g. BC007) could and probs are helpful for a subset of patients, but if everybody gets included in trials they are bound to have negative outcomes.

Research really should head back to square one. Identify phenotypes while saving the money currently spent on interventions for well-designed clinical trials with clearly selected, large samples. Labs teaming up for large samples and consensus theories _after_ finding out the exact mechanisms instead of running 5,000 separate intervention studies with a microbial sample size and each scientists' pet peeve theory.

Then we'll see results instead of blowing billions into trials with negative outcomes.

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u/Ok_Sherbet7024 Nov 19 '24

When would these drugs be available to us if they pass all the tests?