Anakinra/Kineret (IL-1 inhibitor) in ME/CFS - Dutch study + discussion

Anne

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I know, I fully understand! And like you I don't trust the psychosocial people to report or present results adequately.

Just wondering if anyone hears directly from a patient in the trial - I would love to hear how they are doing (though I know it would all be anecdotal).

I have access to Anakinra/Kineret and am debating whether or not to try it, so any input would mean a lot.

If anyone hears anything....
 

Thomas

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Thomas

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I have access to Anakinra/Kineret and am debating whether or not to try it, so any input would mean a lot.

If anyone hears anything....
Same. Have you heard anything from anyone with ME or from the clinical trial. Peterson in the above presentation I posted in my previous post says the drug would have very little downside. I also heard Klimas say this drug should be helpful but the government is hesitant to give her grant.

@Jonathan Edwards do you think this drug could be a reasonable and safe drug to experiment on? Also, do these types of meds work pretty quickly if they're going to work at all, as in after an injection or two (versus something like Ampligen or RTX which may take months of therapy?) Theoretically speaking...
 

Thomas

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I don't think it is wise to take this drug outside of a clinical trial at this point in time...
Thanks. But I guess the same could be said about any drug that isn't tested in ME. But I was curious at the risk/reward ratio. At the end of the day we have to assume the risk though.
 
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Thanks. But I guess the same could be said about any drug that isn't tested in ME. But I was curious at the risk/reward ratio. At the end of the day we have to assume the risk though.
Cytokine inhibitors like this carry a significant risk of severe infection like disseminated tuberculosis. Analinra may not be as bad as TNF inhibitors but it is not something to play with.
 

BurnA

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I don't think it is wise to take this drug outside of a clinical trial at this point in time...
I understand your caution but I am a bit curious about this comment. What would a clinical trial provide that a knowledgeable medical doctor wouldn't provide ? Having said that, I wouldn't say there is a huge body of knowledge regarding treatment of ME patients with this drug whether its in a trial or not. And of course side effects or efficacy will occur regardless. Its definitely a long shot given how little we know.
 
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I understand your caution but I am a bit curious about this comment. What would a clinical trial provide that a knowledgeable medical doctor wouldn't provide ? Having said that, I wouldn't say there is a huge body of knowledge regarding treatment of ME patients with this drug whether its in a trial or not. And of course side effects or efficacy will occur regardless. Its definitely a long shot given how little we know.
The whole point is that we don't know the efficacy and side effect profile. The whole focus is different - discovery/experimentation, rather than just treatment.

Clinical trials (even if open label), will more rigorously gather data and provide potential guidance and transparency (eg in the case of severe side effects) that might not occur outside of a trial.
 
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What would a clinical trial provide that a knowledgeable medical doctor wouldn't provide ?
How can a doctor be knowledgeable if there has been no trial on which to based that knowledge? If a doctor hands out a treatment for which there is no controlled evidence for efficacy he will have no idea whether to recommend carrying on with the treatment or stopping it at any point, since improvement, or even deterioration might be incidental. Without any biomarker to measure a response biochemically nobody would know what was going on and the same would apply for the next patient and the next...
 

BurnA

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The whole point is that we don't know the efficacy and side effect profile. The whole focus is different - discovery/experimentation, rather than just treatment.

Clinical trials (even if open label), will more rigorously gather data and provide potential guidance and transparency (eg in the case of severe side effects) that might not occur outside of a trial.
Oh I understand and agree about gathering data and publishing everything relevant.
I was thinking more about safety and probably had the recent events in France in my mind. I realise that was phase 1 but if that can happen in a controlled trial it makes you wonder.
I guess it would or does happen more outside of trials but we just don't hear about it.
 

Thomas

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Cytokine inhibitors like this carry a significant risk of severe infection like disseminated tuberculosis. Analinra may not be as bad as TNF inhibitors but it is not something to play with.
Thank you, sir. I understand your position. I figured the risk was less with this medication but guess I'm wrong. Same argument though - as patients we are desperate to feel better and don't really have 10 or 15 years for science to hurry up and come to a conclusion.
 

Jill

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Yep we don't have 15 years to spare. The Norwegians wouldn't be doing what they are doing without having a bit of daring. My partner has had a gutsful, has tried every conceivable med, has tried to suicide and would try anything, sign any waiver just to even be a Guinea pig so something could be learnt from him. He can just about still eat. Getting to a toilet is a problem as is speaking. Zero quality of life . I agree we need controlled trials - we've been waiting for 35 years .
 

Anne

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The principal investigator for the trial is Jos van der Meer, one of the Dutch psychobabblers. So it'll primarily include chronic fatigue patients, the results will be spun to obey the prime directive that only CBT can be helpful, and even if they're forced to publish any indication of improvement, they'll conclude that the treatment is too dangerous for patients with something as non-serious as CFS and that CBT is still the superior treatment.

Anyone wanna place some bets? :D

...

They're associated with the Nijmegen group, which recruits from their psychosomatic "fatigue" center. I wouldn't go anywhere near them, for any reason.
I think you are right, @Valentijn. I'm getting more convinced that the results will be negative, and they will use them for their spin. It doesn't matter that there is at least one good immunologist from elsewhere involved in the study, if patient recruitment is bad, the results will not be representative of ME.

They are using the Fukuda criteria, so no obligatory PEM as far as I understand. And am I right in assuming that the fact that they are recruiting from their "chronic fatigue" clinic means the study will have the same problems as MEGA: that the majority of the patients there don't have actual ME (CCC or ICC defined), because informed ME patients don't (as you say) go near them, and ME patients who do go there drop out because CBT/GET makes them worse, or are cut of because they don't respond to CBT/GET?
 
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Valentijn

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And am I right in assuming that the fact that they are recruiting from their "chronic fatigue" clinic means the study will have the same problems as MEGA: that the majority of the patients there don't have actual ME (CCC or ICC defined), because informed ME patients don't (as you say) go near them, and ME patients who do go there drop out because CBT/GET makes them worse, or are cut of because they don't respond to CBT/GET?
Probably. Most of the people at the clinic I went to did not have ME/CFS. There were 3 or 4 I could see it in ... most were nicely dressed and with make-up, bored and fidgeting, bouncing babies on their laps, etc, in the waiting room.

The clinic I was at (not Nijmegen) also kicks patients out after 12 months, according to the contract, though sometimes might extend the "treatment" to 18 months for an additional fee. In my case, the travel, "relaxation" therapy, and stair climbing to get to offices was making me crash, so I cancelled my future appointments. They retaliated by removing their diagnosis of me having CFS, and replaced it with a diagnosis of being overweight :p

I wouldn't trust a single thing coming out of a Dutch fatigue clinic, except the horror stories coming from patients!