Open Norway: Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome, 2025

I kind of disagree, even though I think my onset was progressive as well.

I think it's unlikely that we find a treatment that works for everyone diagnosed with ME/CFS. So if the researchers have a hunch itll work better for a specific subgroup, it makes sense to at least have the small scale pilots on those subgroups. To increase their chances of statistical significance.

Of course, when it becomes a problem is if one subgroup is disproportionately left of out of research on ME (like severe people).


But I definetely want to avoid whatever is going on in long COVID research where they are lumping people who got post-icu syndrome from COVID and people who got autoimmune illnesses from COVID into a single drug trial and acting surprised when the drug doesn't work.

 

I think it makes sense to focus on one specific subgroup if you believe that ME/CFS might actually be a group of different diseases.

I have not seen anything that indicates that they believe that people without an infectious onset doesn’t have ME/CFS.

And they have been very clear about how horrible ME/CFS is. An example is how they are cancer researchers were very surprised to encounter patients that wanted more chemo. That says something about how bad their suffering is.

And how they say that the more severe with ME/CFS often are as sick or sicker than terminally ill stage 4 cancer patients.

They are also one of very few groups trying to study the more severe spectrum. I would not be surprised if they turned their attention to the very severe or worse if they find success with this trial.

I wish they were more outspoken in the media in Norway because the BPS lobby is so prominent, but that’s the only thing I feel like I can fault them for.

 

Yes that makes sense and it sounds like a sensible way to increase probability that everyone has the same illness, in the absence of a diagnostic test. I feel that many of us who can't pinpoint an exact start date of our illness with 100% certainty will actually still fit in to that same subgroup - the illness process was started by a virus but the effects built up more gradually. But yes, I can see the sense in focusing on those who can pinpoint a virus as the starting point. So long as they can find enough people in this group.

 

They had many more patients in their previous larger trials so I don’t think recruitment is going to be an issue.

 

Realistically, what are the risks of participating/taking this mAb? Sure the immune system will be down for a little while, but it should recover fine, right? What are the biggest realistic risks?

 

I’m assuming the biggest risk is death due to e.g. an infection that you’re unable to defend against?

When dara is used for cancer, we accept the risks because the alternative is death regardless.

 

So if Dara were a very effective treatment for a subset of pwME and they could live relatively normal lives. They would still be limited by the fact they would have a suppressed immune system and therefore need to be very careful via masking etc. avoiding crowds, disinfecting even small cuts, and regardless would have a higher risk of death?

As a person who can’t do anything, I’d take that in a heartbeat. But if I was mild or moderate, I’m not sure I would, especially if there is promising research looking like a better alternative is coming out soon.

 

Immune system should come back—and hopefully normal-ish. I’m guessing that in multiple myeloma they need regular cycles with dara to keep cancer under control, so they will be immunocompromised.

For Campath (different drug) JE says patients go for a long time with no T cells and they seem to be OK.

https://www.s4me.info/threads/hyper...verity-of-long-covid-2025-renner-et-al.43870/

 

But wouldn’t Dara be a “for life” type treatment?

 

That’s a million dollar question. Maybe will hear something from Fluge next month. For cyclo, for the six year follow-up, a lot of the patients are still in remission.

“Conclusions: After six years, 44.1% of the cyclophosphamide group scored an SF-36 PF of at least 70, and 17.6% of at least 90, suggesting that cyclophosphamide in a subgroup may modulate the disease course in a beneficial way.”

 

Google translated:

https://twitter.com/user/status/1891069465686634514

 

I must say that I don’t like this kind of info being published on SoMe instead of in a case series or something similar.

It reads like an advertisement for an untested, expensive and potentially dangerous treatment.

And is the reduction in autoantibodies and Ig even relevant as a measure? Presumably that’s expected with this drug?

 

The study by the Norwegians is talked about here around 12:40. They are also planning to do a placebo controlled trial:

https://www.youtube.com/watch?v=nCik6NamXdo

 

Yes, the reductions simply show that the drug is doing what it is designed to do.

 

I can understand, but it is however interesting that several groups or MDs are testing the same drug at the moment. Especially considering the Norwegians are in the works of (eventually) conducting a placebo controlled trial.

 

I don’t think the fact that multiple groups tries it tells us much about the efficacy of the drug. It might just as well tell us what’s hyped or what they can earn money on.

 

True, but that was also not the point of me posting it. Just that it was used and/or researched in different places. We'll see after the trial about the actual efficiency.

 

But they aren’t researching it. They are just using it and collecting what seems to be irrelevant data. They also claim that it works:

So I find their behaviour problematic on many levels.

Only Fluge and Mella are actually researching the drug.

 

Yes, you're surely right. But death is the biggest risk in driving a car as well. I wonder what the chances are to die from daratumumab (and not multiple myeloma eventually)?
And then, realistically, what other risks there are besides death.
I suppose IVIG would be a way to reduce infection risk?

 

No idea about the chances or how to mitigate the effects.