Open 2022 Pilot study in Norway - Daratumumab in ME/CFS

[V.R.T.]

https://bsky.app/profile/oppklipt.bsky.social/post/3lomv6fzgpc2i

This was posted by an ME patient on Bluesky earlier. Can't verify source as I'm not on Facebook. Let me know if this link isn't ok.

Reporting that Daratumumab pilot results were presented at the Norwegian conference: 6 could walk 10,000 steps after treatment, the other 4 showed no change.

If this is true this is fascinating and encouraging. It sort of tracks with cyclo right? Or maybe is a better ratio of patients responding. If these results were to stand up in phase 2 the question would be are the non responders a subgroup with different pathology or is the Daratumumab affecting signals in the responders it isn't touching in the non responders for some reason?

Again maybe this Facebook group is misreporting, I guess we'll know later today or when the videos come out.

 

[Jaybee00]

I don’t think that’s totally correct. The slide only shows the IGG levels over time. We should know a bit more in a couple hours when the night session takes place.

From that slide—need to know which patients were classified as responders. If the high IGG patients didn’t respond, that’s an important finding.

 

[Utsikt]

https://bsky.app/profile/oppklipt.bsky.social/post/3lomv6fzgpc2i

This was posted by an ME patient on Bluesky earlier. Can't verify source as I'm not on Facebook. Let me know if this link isn't ok.

Reporting that Daratumumab pilot results were presented at the Norwegian conference: 6 could walk 10,000 steps after treatment, the other 4 showed no change.

If this is true this is fascinating and encouraging. It sort of tracks with cyclo right? Or maybe is a better ratio of patients responding. If these results were to stand up in phase 2 the question would be are the non responders a subgroup with different pathology or is the Daratumumab affecting signals in the responders it isn't touching in the non responders for some reason?

Again maybe this Facebook group is misreporting, I guess we'll know later today or when the videos come out.

I can confirm the post exists in the fb group, but it’s by another patient. I see no reason to doubt the reporting by the patient. It aligns with the emails above.

 

[Utsikt]

I don’t think that’s totally correct. The slide only shows the IGG levels over time. We should know a bit more in a couple hours when the night session takes place.

From that slide—need to know which patients were classified as responders. If the high IGG patients didn’t respond, that’s an important finding.

I’m assuming they had more slides.

 

[V.R.T.]

I don’t think that’s totally correct. The slide only shows the IGG levels over time. We should know a bit more in a couple hours when the night session takes place.

From that slide—need to know which patients were classified as responders. If the high IGG patients didn’t respond, that’s an important finding.

Yeah I don't think the slide was claimed to show the results. But yeah perhaps I should have just waited for the night session! We shall see what is what then.

 

[Jaybee00]

Also why are there black horizontal lines around 6 and 12 IGG? Does the 6 line mean that’s where the response began?

 

[Jaybee00]

Looks like 4 patients dropped out or are maybe further behind in data collection?

 

[Utsikt]

Looks like 4 patients dropped out or are maybe further behind in data collection?

I suspect those might have been the non-responders?

 

[Utsikt]

There’s some talk in the fb-group about how the responders had a certain HLA type. Will be very interesting to see the recording from this evening and the paper when it’s published.

Edit: I might have been too eager here. The comment was ambiguous and someone pointed out that it might have been the previous studies they were referring to. Will update if any of the people that attended responds with more info.

 

[Jaybee00]

There’s some talk in the fb-group about how the responders had a certain HLA type. Will be very interesting to see the recording from this evening and the paper when it’s published.

This is from the cycloME trial.

 

[Utsikt]

This is from the cycloME trial.

Ah, that makes sense. Will be interesting to know if they looked at it here as well.

 

[V.R.T.]

If this HLA-improvement association holds up in the dara trials, surely this is massive? Like a subset of significant responders to a certain type of drug could not only help so many people but tell us a lot about the pathways involved, perhaps in the non responders too.

Especially if it's like half or more of all pwME.

I mean I feel like if that holds up then they can tell who could benefit before treatment and the treatment should (morally speaking I mean) be rolled out to as many pwME in that subset as possible after phase 2.

 

[Utsikt]

I mean I feel like if that holds up then they can tell who could benefit before treatment and the treatment should (morally speaking I mean) be rolled out to as many pwME in that subset as possible after phase 2.

I’m leaning more towards a phase 3, preferably with multiple countries. You can get FDA approvals from phase 3, and I imagine it’s possible that it might be the same elsewhere.

 

[V.R.T.]

I’m leaning more towards a phase 3, preferably with multiple countries. You can get FDA approvals from phase 3, and I imagine it’s possible that it might be the same elsewhere.

I mean if they were going straight to phase 3 now I'd agree but considering phase 1 took 3 years it hardly seems ethical to make millons of people who could be put into remission wait another 3-4 years after phase 2.

I know I'm going to be told that's just the way it works but I think the urgency of helping severe and very severe patients, at the very least, once we have good data that something is likely to work cannot be overstated.

Severe patients live in constant danger and psychological deprivation. We are a huge suicide risk and require a huge amount of care from our loved ones. If I were to go into remission, my parents could enjoy the last years of their lives instead of caring for me, for example.

Especially if we have a reading like the HLA one could be which tells us ahead of time who will respond.

 

[OrganicChilli]

Which (blood) tests and biomarkers determine if someone falls into the 60% sub group?

 

[Utsikt]

I mean if they were going straight to phase 3 now I'd agree but considering phase 1 took 3 years it hardly seems ethical to make millons of people who could be put into remission wait another 3-4 years after phase 2.

I know I'm going to be told that's just the way it works but I think the urgency of helping severe and very severe patients, at the very least, once we have good data that something is likely to work cannot be overstated.

Severe patients live in constant danger and psychological deprivation. We are a huge suicide risk and require a huge amount of care from our loved ones. If I were to go into remission, my parents could enjoy the last years of their lives instead of caring for me, for example.

Especially if we have a reading like the HLA one could be which tells us ahead of time who will respond.

We can’t gamble with dangerous drugs just because there is a chance that it might work.

Who should take responsibility if it goes wrong and people get worse or die?

Who should cover the resources for proven treatments that other sick people are deprived of because we used a limited healthcare budget on experimental and unproven treatments?

Everyone wants treatments as soon as possible. But there are many very good reasons that we do trials first.

 

[Arfmeister]

6 could walk 10,000 steps after treatment, the other 4 showed no change.

This information is from the same bluesky-post. See image attached.

@Utsikt as you are in the Norway Facebook group where this info comes from:

1) are they indeed talking about severe ME ?
- because from severe (= max 400 steps?) to 10.000 steps is impressive

2) and 60% response rate (6 of 10) was commented in the presentation ?
- as in the IgG graph there are only 9 lines

 

[Utsikt]

1) are there indeed talking about severe ?
- because from severe (= max 500 steps?) to 10.000 steps is impressive

I don’t know more than what the post says. It’s a direct copy.

 

[V.R.T.]

We can’t gamble with dangerous drugs just because there is a chance that it might work.

Who should take responsibility if it goes wrong and people get worse or die?

Who should cover the resources for proven treatments that other sick people are deprived of because we used a limited healthcare budget on experimental and unproven treatments?

Everyone wants treatments as soon as possible. But there are many very good reasons that we do trials first.

I am aware there is a reason we do trials. But we have the data from phase 1 and 2 cyclo and phase 1 Daratumumab, plus in this hypothetical situation we would have a positive phase 2 dara. If these all show that around half recipients are going into remission there needs to be some kind of accelerated approval. Nobody here is suggesting that we should start injecting people with random drugs. But that should be enough data that this approach significantly helps to at least roll out accelarated approval in parallel with phase 3.

We are talking about years of people's lives in some of the most intense suffering a person can experience. 10,000 steps is remission. You can't honestly tell me that you wouldn't take that chance? I would take it in a heartbeat if the phase 2 was positive and there were no significant adverse events.

I do not have eight to ten years to wait, frankly. I and countless other severe people will die if there is not a treatment relatively soon.

I am sorry to be so blunt but that is the reality we are dealing with.

 

[Utsikt]

I am aware there is a reason we do trials. But we have the data from phase 1 and 2 cyclo and phase 1 Daratumumab, plus in this hypothetical situation we would have a positive phase 2 dara. If these all show that around half recipients are going into remission there needs to be some kind of accelerated approval. Nobody here is suggesting that we should start injecting people with random drugs. But that should be enough data that this approach significantly helps to at least roll out accelarated approval in parallel with phase 3.

We are talking about years of people's lives in some of the most intense suffering a person can experience. 10,000 steps is remission. You can't honestly tell me that you wouldn't take that chance? I would take it in a heartbeat if the phase 2 was positive and there were no significant adverse events.

I do not have eight to ten years to wait, frankly. I and countless other severe people will die if there is not a treatment relatively soon. I will die by suicide and many others will too, and many will die like Maeve and others I could name in unthinkable agony.

I am sorry to be so blunt but that is the reality we are dealing with.

You have not really addressed any of the points I highlighted, so I don’t really see any reason to go back and forth saying that we disagree with each other. There are other threads dedicated to the considerations with regards to trialing drugs, so we should try to avoid derailing this thread any further.