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

rapidboson said:
Yes, you're surely right. But death is the biggest risk in driving a car as well.
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And if there wasn’t massive social and institutional and infrastructural inertia behind the car being used for transport, it would probably be far more regulated than now.

Kind of like alcohol (alcohol is more dangerous than something like cannabis in practically every way).

Both alcohol and cars lead to a massive amount of preventable deaths, but they’re so engrained in our cultures its political suicide to try and do something big about it.

https://en.m.wikipedia.org/wiki/Path_dependence
 
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Yann04 said:
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.
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Yes I would also take this risk in a heartbeat but would have to think very hard if I was mild and things continue to pan out as JE has been talking about with the science.
 
V.R.T. said:
Yes I would also take this risk in a heartbeat but would have to think very hard if I was mild and things continue to pan out as JE has been talking about with the science.
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Yeah, I agree. Also, temporary immune suppression—for a number of weeks—is one thing, but even as a moderately ill person I wouldn't choose a drug that caused significant immune suppression in the long term. Not for ME/CFS at least.

The risk/benefit calculation is very different for people who're severely ill, of course.
 
Utsikt said:
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.
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I very much agree. I have a lot of respect for Fluge and Mella. Not so much for those selling the drug as a treatment before the research is there for people to be able to make in informed choice.

V.R.T. said:
as JE has been talking about with the science
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Have I missed something here? If so, can someone point me in the direction of relevant thread? ty
 
From an email response from Haukeland—phase 2 is RCT with 66 patients. Better news!

“Thank you for your message. I can confirm that we are planning a phase 2 trial of daratumumab at Haukeland - an RCT with 66 patients. However, we are still awaiting the final approvals from the Norwegian Medical Products Agency, and so we have not yet published any recruitment info for the trial. I believe the information you have found concerns the pilot study we have performed in preparation for the trial. I understand that on some websites advertising clinical trials it still comes up as recruiting. The data for the first ten patients has been submitted for peer review and will hopefully be published in not too long. Dr. Fluge will talk about the results from the pilot in some more detail in Stavanger, although he will still be somewhat limited by the restrictions posed by the medical journal reviewing the manuscript.
Regarding your question on isatuximab, this is a drug that our doctors have looked into. However, as daratumumab is an older drug, there is more experience with the drug also in autoimmune diseases, and the toxicity profile is better known, and so our assessment is that the risk in testing the drug in a new population is acceptable.”
 
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Screenshot from the Berlin ME/CFS Conference that happened a couple days ago:
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Transcription of Dr. Mella describing this:
And no conclusions should be made before we have seen the double blind and randomized study. And we have applied and we hope to get this approved this month. This will be a double blind, phase 2, placebo-controlled trial. Daratumumab versus placebo.

Placebo is 15 mL of saline with added hyaluronidase, which is an enzyme that is present in the daratumumab to facilitate the absorption subcutaneous in the abdomen. Criteria will be CCC, moderate to severe, at least two years duration. And because we're not sure about these NK cells, we will include patients with NK cells above 125 million per liter. 66 patients.
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Utsikt said:
It might be useful if it shows that HADS can change in non-responders? Essentially proving the uselessness of it as an outcome.

I sincerely doubt that they will claim any benefits if only HADS changes. But I understand your apprehension!
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HADS has already been shown to be useless. But at least it’s not the only measure and comparing it to funcap could be interesting (on the top of my head I can’t remember if similar has been done, although I don’t feel it’s necessary to do as HADS is a bad scale)
 
It would be nice if they did period monitoring of sleep. This can be done inexpensively with at home sleep tests. Or at least a questionnaire—are you sleeping through the night, how many wake-ups during the night, etc.?
 
But is sleep through the night necessary a good enough indicator of good sleep? I've been up three times tonight with a teething baby and I still feel more refreshed than I did when sleeping through the night pre-pregnancy.

If the treatment helps and patients feel better, they may feel they sleep better despite evidence to the contrary such as multiple wake ups.
 
Utsikt said:
Aren’t those quite unreliable?
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Yes. Apparently head electrodes and cameras are needed even to show whether or not someone is asleep, never mind determine what stage of sleep they're in. That's why specially equipped labs are used for diagnosis.

The watches are consumer gadgets that record heart rate and how much the wearer was moving, then make a guess. It's not feasible for them to do any more than that.
 
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