Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al

ryanc97 said:
FYI @V.R.T. i have some new info that the worsening anecdote might actually be due to another drug withdrawal. As I piece it together, it makes more sense. So if true, nobody has worsened on Dara.

This aligns with the study where nobody worsened and this piecing together makes a lot more sense.
Click to expand...
He's referring to me. Dara absolutely worsened me in every regard. I thought at first it could've been coincidental to interdose benzo withdrawl, I experimented with dosing for a few months and am back on the dose I was on pre and during treatment with no change. Ryan just can't bear the fact that his pet treatment could make anyone worse.

I began with 300nk cells, and 1241 igg. Oddly, my igg2 was higher than igg1. After 2 doses my igg fell to low 700s and nk cells to 53. At first I noticed improvements in fatigue, but I quickly deteriorated across all symptoms (sleep, fatigue, OI, and even developed a new symptom, internal tremor). It's been 2 months and there is not yet sign of recovering baseline. I started at severe and am now extremely severe. I am peeing in bottles etc.
 
Last edited by a moderator:
Verity said:
I am really sorry to hear this. Can I ask how far into treatment you started going downhill?
Click to expand...
Yes, I had very bad reactions to each dose but it's hard to say if it was steroid induced or not. I've taken steroids before, always crashed but recovered in a week or so. After recovering from dose 1, I took dose 2 three weeks later (I was not well enough to take it 2 weeks after). I crashed again, then started to notice some energy increase for a week or so, but then really began to decline after that.

I took half the recommended steroid dose for dose 2 thinking it would be best to avoid the steroid crash, but perhaps this induced some cytokine storm which has led to my present condition.

Male, 39 y/o, sick since 2/28/24
 
oedi said:
Yes, I had very bad reactions to each dose but it's hard to say if it was steroid induced or not. I've taken steroids before, always crashed but recovered in a week or so. After recovering from dose 1, I took dose 2 three weeks later (I was not well enough to take it 2 weeks after). I crashed again, then started to notice some energy increase for a week or so, but then really began to decline after that.

I took half the recommended steroid dose for dose 2 thinking it would be best to avoid the steroid crash, but perhaps this induced some cytokine storm which has led to my present condition.

Male, 39 y/o, sick since 2/28/24
Click to expand...
Thanks for the additional information. Hard to know, as you say, but it does sound potentially relevant that you previously crashed from steroids and then had this reaction.

Did you continue to take it after these two doses?
 
Verity said:
Thanks for the additional information. Hard to know, as you say, but it does sound potentially relevant that you previously crashed from steroids and then had this reaction.

Did you continue to take it after these two doses?
Click to expand...
No. It's also worth saying that the 2nd dose crash felt very different internally than ever before, including the one after dose 1. For about 24 hours I felt a body wide burning blood/veins type feeling. Everything was on fire.

I've taken steroids on several occasions before and always reacted poorly, but I always recovered baseline in a week.
 
oedi said:
No. It's also worth saying that the 2nd dose crash felt very different internally than ever before, including the one after dose 1. For about 24 hours I felt a body wide burning blood/veins type feeling. Everything was on fire.

I've taken steroids on several occasions before and always reacted poorly, but I always recovered baseline in a week.
Click to expand...
Yikes, sounds awful. If your doctor had any idea what sort of reaction that was, I’d be curious to know, but I also don’t want to bother you with too many questions if you’re tapped out!
 
ryanc97 said:
Nobody knows how these antibodies work. It’s possible immunoadsorption doesn’t get rid of them, or, they come back very fast.
Click to expand...
There was one presentation at the Berlin conference on how the benefit seemed to be prolonged even when the antibody clearance was short.

Hopefully one of those "hmm, that's strange" moments for a curious scientist
 
oedi said:
He's referring to me. Dara absolutely worsened me in every regard. I thought at first it could've been coincidental to interdose benzo withdrawl, I experimented with dosing for a few months and am back on the dose I was on pre and during treatment with no change. Ryan just can't bear the fact that his pet treatment could make anyone worse.

I began with 300nk cells, and 1241 igg. Oddly, my igg2 was higher than igg1. After 2 doses my igg fell to low 700s and nk cells to 53. At first I noticed improvements in fatigue, but I quickly deteriorated across all symptoms (sleep, fatigue, OI, and even developed a new symptom, internal tremor). It's been 2 months and there is not yet sign of recovering baseline. I started at severe and am now extremely severe. I am peeing in bottles etc.
Click to expand...

I think unless you lay out the timeline, it is difficult to conclude if it is the Dara, steroids or benzos. Especially the benzo usage timeline and dose ramp up/down.

Internal tremors are very much commonly discussed in benzo communities, but also there are many stories in the ME CFS subreddit. So I’m not ruling it out. However…

At the same time, many ME CFS are using long term psych drugs, SSRI, SNRI, benzos….. which also is connected to internal tremors which confounds things..


I have also mentioned if it is Dara worsening, it is likely because deletion of IGG happens but from good LLPC not bad LLPC. Then what happens is the bad IGG have less good IGG to shield them, and reduces the natural IVIG effect.

And lastly, if it is permanent worsening from Dara, the trial evidence tells us 10 in P1 with no AE, 20 in P2, 1 temporary SAE requiring 3 day hospitalisation. Offlabel use would be 6-8, with 1 long term SAE. Don't know what to make of those odds.
 
Last edited:
ryanc97 said:
I think unless you lay out the timeline, it is difficult to conclude if it is the Dara, steroids or benzos. Especially the benzo usage timeline and dose ramp up/down.

Internal tremors are very much commonly discussed in benzo communities, but also there are many stories in the ME CFS subreddit. So I’m not ruling it out. However…

At the same time, many ME CFS are using long term psych drugs, SSRI, SNRI, benzos….. which also is connected to internal tremors which confounds things..


I have also mentioned if it is Dara worsening, it is likely because deletion of IGG happens but from good LLPC not bad LLPC. Then what happens is the bad IGG have less good IGG to shield them, and reduces the natural IVIG effect.
Click to expand...
The benzo usage is completely irrelevant like I've communicated to you multiple times. I had been on a consistent and unchanged dose for 9 months. The tremors started after dara dose 2 with no change in benzo dosage. I then experimented with dosing in multiple ways, initially increasing due to the immediate worsening, without any discernable change in the tremors. I even went cold turkey for 2 weeks and am back on my initial dose without any change. Tremors only seem to increase with exertion and wan with radical rest.

I've told you this more than once and you failed to correctly report that to this forum in favor of your own perception.

As for the steroids, it is of course possible but I've endured many steroid crashes, at equivalent doses, in the past without permanent worsening. My Pemgarda infusions with steroids are one example. And then there is the unique burning reaction I experienced after dose 2. The most likely explanation is dara made me permanently worse. I'll let the people here judge for themselves
 
Last edited:
oedi said:
Yes, I had very bad reactions to each dose but it's hard to say if it was steroid induced or not. I've taken steroids before, always crashed but recovered in a week or so. After recovering from dose 1, I took dose 2 three weeks later (I was not well enough to take it 2 weeks after). I crashed again, then started to notice some energy increase for a week or so, but then really began to decline after that.

I took half the recommended steroid dose for dose 2 thinking it would be best to avoid the steroid crash, but perhaps this induced some cytokine storm which has led to my present condition.

Male, 39 y/o, sick since 2/28/24
Click to expand...
I've seen you post about your dara trial elsewhere I think, and I am very sorry to hear it ended up this way. It sounds incredibly scary.

I hope with more time your functioning improves.
 
oedi said:
The benzo usage is completely irrelevant like I've communicated to you multiple times. I had been on a consistent and unchanged dose for 9 months. The tremors started after dara dose 2 with no change in benzo dosage. I then experimented with dosing in multiple ways, initially increasing due to the immediate worsening, without any discernable change in the tremors. I even went cold turkey for 2 weeks and am back on my initial dose without any change. Tremors only seem to increase with exertion and wan with radical rest.

I've told you this more than once and you failed to correctly report that to this forum in favor of your own perception.

As for the steroids, it is of course possible but I've endured many steroid crashes, at equivalent doses, in the past without permanent worsening. My Pemgarda infusions with steroids are one example. And then there is the unique burning reaction I experienced after dose 2. The most likely explanation is dara made me permanently worse. I'll let the people here judge for themselves
Click to expand...
I just spoke to a friend in Norway, the person who got worse in the trial was absolutely due to the drug. Went from moderate to bedbound for 10 weeks then back to baseline, just to give you some hope. Another one lost all her hair, they had not heard of any improvements yet. This drug is no joke, but hopefully we will learn more about it from the trial. Fingers crossed you start to improve soon!
 
Jordan09 said:
I just spoke to a friend in Norway, the person who got worse in the trial was absolutely due to the drug. Went from moderate to bedbound for 10 weeks then back to baseline, just to give you some hope. Another one lost all her hair, they had not heard of any improvements yet. This drug is no joke, but hopefully we will learn more about it from the trial. Fingers crossed you start to improve soon!
Click to expand...

Lost all her hair due to Daratumumab in the trial? What?

That is not a side effect of Dara at all. Also, Fluge in the talk said only one SAE, with a hospital visit. You think it’s the same person?
 
Last edited:
Jordan09 said:
I just spoke to a friend in Norway, the person who got worse in the trial was absolutely due to the drug. Went from moderate to bedbound for 10 weeks then back to baseline, just to give you some hope. Another one lost all her hair, they had not heard of any improvements yet. This drug is no joke, but hopefully we will learn more about it from the trial. Fingers crossed you start to improve soon!
Click to expand...
Are you talking about participants in the phase 2 trial?
 
ryanc97 said:
Lost all her hair due to Daratumumab in the trial? What?

That is not a side effect of Dara at all. Also, Fluge in the talk said only one SAE, with a hospital visit.
Click to expand...
It is true, she posted it on social media. Not recognised as an SEA but could be drug induced alopecia, or just random, she could have had placebo. But happened right after she started the trial
 
You must log in or register to reply here.
Back
Top Bottom