New Rituximab ME/CFS open-label phase II study with rituximab maintenance treatment

[BurnA]

However, there is no way that you can 'inflate' 'real' results in a double blind controlled trial like the Norwegain phase 2 study. There cannot be any bias that produces a difference that is not there. Even if you chose very 'placebo sensitive' cases, which does not seem to be true because the controls did not respond, the difference cannot be inflated.

But we are left with the problem that if you take all the patients attending a clinic such as OMI who conform to CCC criteria (or whatever) then the rate of response generated in Norwegian trials may not pan out. What may be important is that the Norwegian phase 2 patients had been referred to a government run health service neurologist. That may mean that they are a different subset of CCC conformers than those attending OMI - for all sorts of reasons.

What we do not know is whether the Norwegian referral system or referral to OMI is most representative of ME patients as a whole.

It certainly would seem to be the most likely reason for a variation in results, especially if more patients who visit OMI are self diagnosed, or if there is not a uniform diagnostic approach there.
It would also suggest that, assuming the norwegians apply the same criteria for the phase III trial as the phase II trials, the results shouldn't be too dissimilar.

Of course the biggest question now is....when are you opening a paying clinic for those interested in Rituximab ??

 

[Jonathan Edwards]

Of course the biggest question now is....when are you opening a paying clinic for those interested in Rituximab ??

Sadly, I am no longer a registered medical practitioner. I decided I should let others run the show.

 

[BurnA]

Sadly, I am no longer a registered medical practitioner. I decided I should let others run the show.

Hmmmm, some might say you are running the best show in town

 

[Hutan]

"Kogelnik felt the success of the early Rituximab trial shifted the conversation for chronic fatigue syndrome (ME/CFS) in a good direction but he’s cautious about the future of Rituximab in ME/CFS. Since researchers tend to pick patients they think will prove their theory early, small studies runs the risk of having inflated results. Dr. Peterson has warned about this as well."
"The fact that Kogelnik’s worried about patient selection suggest, however, that he’s not getting the kind of jaw-dropping results Fluge and Mella did."
/QUOTE]

Cort's article was written back in 2013. Kogelnik may have been hedging his bets (quite reasonably) at a time when there had been less results from Fluge and Mella's work. Also perhaps OMI may not have administered Rituximab to many people at that time.

I'm interested to know what Kogelnik thinks about Rituximab now.

 

[deleder2k]

If you were a registered medical practitioner, would you consider it now? Or perhaps if NHS deny patients RTX

Sadly, I am no longer a registered medical practitioner. I decided I should let others run the show.

I think the real issue here is that no one is running the show in the U.K. Maybe there is a show in some lab somewhere, but it is not easy for us patients to find that show. If you were a registered medical practitioner and needed funds for a Rituximab trial for ME/CFS, would you think about doing off label treatment from your own private centre?

 

[perrier]

Cort's article was written back in 2013. Kogelnik may have been hedging his bets (quite reasonably) at a time when there had been less results from Fluge and Mella's work. Also perhaps OMI may not have administered Rituximab to many people at that time.

I'm interested to know what Kogelnik thinks about Rituximab now.

Is there no way of getting this information from Dr Kogelnik?

 

[deleder2k]

I have read somewhere that Kogelnik sees the same results as the Norwegian's does. Can't remember where it was posted though.

 

[Riley]

I don't understand why Dr. Kogelnik has not been more open with his results with Rituximab. I am a patient of another CFS specialist who says he has been rather cagey about sharing what he is doing.

It has been a while since we talked about it though.

Also, I'm not attacking Dr. K. Maybe there is a good reason?

 

[Jonathan Edwards]

If you were a registered medical practitioner, would you consider it now? Or perhaps if NHS deny patients RTX

I think the real issue here is that no one is running the show in the U.K. Maybe there is a show in some lab somewhere, but it is not easy for us patients to find that show. If you were a registered medical practitioner and needed funds for a Rituximab trial for ME/CFS, would you think about doing off label treatment from your own private centre?

If I had had expertise in ME/CFS management I might well have set up a trial on my own but I do not think I would have treated paying patients on an open label basis. I got near to something like that in RA and rapidly backed off because it was clear to me that the admin system would want to milk patients for as much as they could get and I could see all sorts of conflicts of interest. Even if I had gone ahead it would have been as some form of published trial. Moreover it was easier in RA because it was obvious right from the start that the drug worked - the impact was so easily measurable there was no need for a controlled trial in reality.

 

[BurnA]

If I had had expertise in ME/CFS management I might well have set up a trial on my own but I do not think I would have treated paying patients on an open label basis. I got near to something like that in RA and rapidly backed off because it was clear to me that the admin system would want to milk patients for as much as they could get and I could see all sorts of conflicts of interest. Even if I had gone ahead it would have been as some form of published trial. Moreover it was easier in RA because it was obvious right from the start that the drug worked - the impact was so easily measurable there was no need for a controlled trial in reality.

Do you think there would be a benefit to be gained by collaboration with a ME/CFS doctor who would treat patients under your supervision ? Apart from the potential benefits to patients it could raise a lot of money for your research.

Also,just a few thoughts, given the potential shift from a neurological to immunological disorder, what type of consultant is going to treat ME/CFS patients in the future? For a patient diagnosed from now on – would they be better off seeing an immunologist rather than a neurologist even if the immunologist may not be familiar with ME/CFS ? Does the rituximab work press the reset button on ME/CFS, in which case any doctor who previously treated ME / CFS may not be the best or no more suitable to see than a doctor who hasn't seen an ME /CFS patient, yet is familiar with rituximab ?

 

[Jonathan Edwards]

Do you think there would be a benefit to be gained by collaboration with a ME/CFS doctor who would treat patients under your supervision ? Apart from the potential benefits to patients it could raise a lot of money for your research.

Also,just a few thoughts, given the potential shift from a neurological to immunological disorder, what type of consultant is going to treat ME/CFS patients in the future? For a patient diagnosed from now on – would they be better off seeing an immunologist rather than a neurologist even if the immunologist may not be familiar with ME/CFS ? Does the rituximab work press the reset button on ME/CFS, in which case any doctor who previously treated ME / CFS may not be the best or no more suitable to see than a doctor who hasn't seen an ME /CFS patient, yet is familiar with rituximab ?

The research at UCL is in collaboration with several ME/CFS doctors (and Drs Fluge and Mella) but it is not up to me to 'supervise'. Doctors need to make their own decisions about patients' treatment. I don't really see treating as a way of raising money. If people want to donate to research that is fine. But personally if I was asking people to pay for treatment I would expect to give them value for money.

 

[BurnA]

The research at UCL is in collaboration with several ME/CFS doctors (and Drs Fluge and Mella) but it is not up to me to 'supervise'. Doctors need to make their own decisions about patients' treatment. I don't really see treating as a way of raising money. If people want to donate to research that is fine. But personally if I was asking people to pay for treatment I would expect to give them value for money.

Understood, thanks, it was just a random thought ( inspired by your RA story )

Purely to provoke thought...
Regarding 'expertise in ME/CFS management' and my other thoughts, how expert is this expertise when historically the treatment options were (pretty much) zero and so much was ( and remains) unknown. I dont want to make light of any doctors work in treating ME/CFS but if one patient saw a psychiatrist for 5 years and another a neurologist is one more qualified as an expert in ME/CFS if it turns out to be an immunological issue ?
I want to stress this is purely a thought exercise, an analogy might be... if I have an issue with my PC and I give it to a software expert, and just in case, I also let a microchip expert look at it. Well if it turns out to be a problem with the battery are either of those experts any more qualified to fix my PC ? Is this a poor analagy ?

 

[Jonathan Edwards]

Understood, thanks, it was just a random thought ( inspired by your RA story )

Purely to provoke thought...
Regarding 'expertise in ME/CFS management' and my other thoughts, how expert is this expertise when historically the treatment options were (pretty much) zero and so much was ( and remains) unknown. I dont want to make light of any doctors work in treating ME/CFS but if one patient saw a psychiatrist for 5 years and another a neurologist is one more qualified as an expert in ME/CFS if it turns out to be an immunological issue ?
I want to stress this is purely a thought exercise, an analogy might be... if I have an issue with my PC and I give it to a software expert, and just in case, I also let a microchip expert look at it. Well if it turns out to be a problem with the battery are either of those experts any more qualified to fix my PC ? Is this a poor analagy ?

I am not sure it matters what speciality the doctor is officially trained in. What matters is that they are familiar with the scope of the literature and have experience with patients. There are people with those skills around.

 

[Gijs]

I have read somewhere that Kogelnik sees the same results as the Norwegian's does. Can't remember where it was posted though.

If i remember well Kogelnik didn't get the same results as Fluge e.a. In Germany there was a pilot of 10 CFS patiënts with rituximab no positive results at all! 2 have had a severe bad reaction. I am not so optimistic about rituximab.

 

[undercover707]

I will

Is there no way of getting this information from Dr Kogelnik?

I have an appointment with Dr. Kogelnik at the end of January. I will try to find out and post here.

 

[deleder2k]

If i remember well Kogelnik didn't get the same results as Fluge e.a. In Germany there was a pilot of 10 CFS patiënts with rituximab no positive results at all! 2 have had a severe bad reaction. I am not so optimistic about rituximab.

Kogelnik is still offering RTX treatment. I guess he wouldn't do that if the results were very poor.
I am sure that he said somewhere that he saw the same results as the Norwegians.. I just can't remember where and when.

Since the German pilot study and Kogelnik's experiences with RTX isn't published, it is impossible to confirm or validate what they say. We have two real studies from Norway now that shows a major effect on 2/3 of people treated. I am sure the phase 3 result will be somewhat lower, but if 50%+ responds to the drug it is still fantastic.

One interesting anecdote: I know about a patient in the new cyclo trial which was a non responder to RTX. That patient has now responded greatly to cyclophosphamide.
Stuff like that gives me hope! Maybe there is a cure for all of us.

 

[Freddy]

In Germany there was a pilot of 10 CFS patiënts with rituximab no positive results at all! 2 have had a severe bad reaction. I am not so optimistic about rituximab.

Hi Gijs,

I would be interested in your source for these German pilot study? Really, no positive result at all?

 

[deleder2k]

this was in 2013.. I wish he could give us some numbers. Remember to enable subs by clicking CC

 

[Kati]

It certainly would seem to be the most likely reason for a variation in results, especially if more patients who visit OMI are self diagnosed, or if there is not a uniform diagnostic approach there.
It would also suggest that, assuming the norwegians apply the same criteria for the phase III trial as the phase II trials, the results shouldn't be too dissimilar.

Of course the biggest question now is....when are you opening a paying clinic for those interested in Rituximab ??

Patients going to OMI are not self-diagnosed! OMI sees patients who want to go to OMI, and they (OMI) make a diagnosis based on the presentation, symptoms, blood work. These physicians see patients woth Me and similar illnesses and can telll who is a ME patient and who is not.

 

[Kati]

One interesting anecdote: I know about a patient in the new cyclo trial which was a non responder to RTX. That patient has now responded greatly to cyclophosphamide.
Stuff like that gives me hope! Maybe there is a cure for all of us.

@deleder2k can you say more about this? Any theory that Fluge and Mella can say why it happens?