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

[msf]

It's reassuring to know they used the C.C.

 

[Soundthealarm21]

Wow, I think Wessely just had a breakdown.

I see his quotes and I really just want to slap the dude.

 

[halcyon]

Ooh, and who would those be?

Those with signs of active herpes, enterovirus, and parvovirus infection and/or hypogammaglobulinemia, i.e. some portion of ME patients.

 

[Snowdrop]

Those with signs of active herpes, enterovirus, and parvovirus infection and/or hypogammaglobulinemia, i.e. some portion of ME patients.

I'm not following. Which group are you saying are the AH,EV, and PV--responders or non-respondersto the drug?
Sorry. I need the whole context repeated.

 

[Never Give Up]

Those with signs of active herpes, enterovirus, and parvovirus infection and/or hypogammaglobulinemia, i.e. some portion of ME patients.

Oh, crap! Why can't they(you, my son, etc.) take it?

 

[Sidereal]

We are also conducting an open-label phase II study (KTS-3-2010) aiming to include only patients with either very severe or severe ME/CFS, using the same treatment regimen with rituximab induction and maintenance as described in the study presented here (KTS-2-2010). Patients with very severe ME/CFS have special needs, and both transporting and accommodating them in a busy oncology ward have proved very difficult. Eight patients have been included, and only four with very severe ME/CFS have been given rituximab maintenance treatment in KTS-3-2010. Although the treatment had a slight beneficial effect on two out of four patients with very severe ME/CFS, none of the four will be characterized as responders. B-cell depletion using rituximab for ME/CFS is at present an experimental treatment, and more evidence is needed. We do not encourage the use of rituximab for ME/CFS outside of approved clinical trials, and this is especially important for the group with very severe disease.

 

[msf]

I also find it reassuring that they are reading the work of others, notably Lipkin, Maes and Gottfries.

 

[halcyon]

I'm not following. Which group are you saying are the AH,EV, and PV--responders or non-respondersto the drug?
Sorry. I need the whole context repeated.

I'm just saying these are contraindications for rituximab use and some (unknown) percentage of ME patients have these conditions.

 

[Snow Leopard]

Seems to be a pattern amongst the results. All but one who became ill as an adolescent/teenager responded, along with most middle aged men. Probably not enough to be statistically significant though...

Interesting that one patient had an allergic reaction to the drug, so they switched to the anti-CD20 drug ofatumumab, which had a clinical response, but sadly had to stop after developing breast cancer at 24 months!

Lastly, only one of the people included who was not a part of a previous study improved. This seems odd. But I understand several of these were the 'severe patients'. I'm wondering what this means in terms of placebo... (severe patients generally do not shift their scores due to placebo, whereas milder patients might, yet only 2/5 'mild only' patients were responders...)

 

[msf]

Does anyone else find it a bit odd that Lerner also reported a 66% response rate for his antiviral protocol?

 

[user9876]

Seems to be a pattern amongst the results. All but one who became ill as an adolescent/teenager responded, along with most middle aged men. Probably not enough to be statistically significant though...
!

Do you think that may relate to the age of onset population paper wher there were two peaks one aroiund adolescence?

 

[deleder2k]

I guess because it's a small study - so cheap to run - and indicates whether it might be worth doing a larger trial. In the case of this study it looks like it was a resounding 'yes'. Makes you wonder why they struggled to get funds for the Phase III trial.

They did it after the blinded phase 2 study to figure out the dosing schedule. In the blinded study patients were given only two infusions. In the open study patients were given 6 infusions. That lead to a significant drop in patients relapsing. I think 80% relapsed in the blinded study. In this one approximately 39% (!) relapsed.

 

[Kati]

ME Association statement



STATEMENT BY DR CHARLES SHEPHERD, MEDICAL ADVISER, ME ASSOCIATION

The downside is that Rituximab is a very expensive drug with a potential to cause serious side-effects.

The problem with this statement is, if it's easily available for patients with lymphoma, and in rheumatology, and if governments and insurance companies approve if for these conditions, if it's deemed appropriate and indicated for patients with ME who might actually return to their productive and thriving living, then why is "very expensive drug" a problem? Why are patients with ME not worthy of a treatment that has 2 chances out of 3 to be successful? It is better than lottery!

There are therapies out there which cost much more, for intance the new drugs for Hepatite C, for which my government approved last month.

We are worth the investment. And please leave it to patients to decide whether the potential side effects are worth the risk. An informed decision as part of the consent to treatment is important. Patients ned to read the 'fine print'.

At the local clinic, the bio-psycho-social approach reigns. Definitely, this is a cheaper model than offering treatments like Ampligen, Valcyte, IVIg and Rituximab.

Food for thought. we are worthy of serious medical treatments.

 

[deleder2k]

It is not a very expensive drug, and biosimilars are coming in a few years. In Norway a maintenance dose of Rituximab is $2000. That is $2000 every 3 months. That is nothing compared to many other medicines. Sick patients could get back at work (at least some). It would be economically viable. No doubt about that.

 

[Snow Leopard]

However, 12 out of 14 major responders in this study measured physical activity for 4–6 consecutive days in the time interval 15–20 months follow-up, with a mean value for “mean number of steps per 24h” 9829 (range 5794–18177), and a mean value for “maximum number of steps per 24h” 14623 (range 9310–23407).

Like a dream come true!
Hard to explain that away with the placebo effect!

 

[msf]

Maybe in Norway!

 

[greeneagledown]

It is not a very expensive drug, and biosimilars are coming in a few years. In Norway a maintenance dose of Rituximab is $2000. That is $2000 every 3 months. That is nothing compared to many other medicines. Sick patients could get back at work (at least some). It would be economically viable. No doubt about that.

Unfortunately, in the United States it's more like $5800 to $6800 for a maintenance dose. That's without factoring in infusion costs. But like you said, biosimilars are coming fairly soon.

A very encouraging study, even if most patients will have to wait until insurance/government payers are willing to pick up the tab.

 

[deleder2k]

The medicine cost of a maintenance dose is not $5800 to $6800. It is more like half of that.

Rituximab: In RA, a typical course of rituximab is 1,000 mg given i.v. over about 4 hours, with a second 1,000 mg dose administered 2 weeks later. The AWP cost of rituximab for a 10mg/ml 10ml vial is $582.19. Therefore, the medication AWP cost for a two dose course of therapy at 1,000 mg per course would be $11,643.80. The yearly cost would depend on the number of course required in that time period.

https://www.rheumatology.org/publications/hotline/0506newdrugs.asp


Maintenance dose = 500 mg.


Even though it would have been $6000 it would have been relatively cheap compared to other medicines. People get it for R.A, and other diseases that is less disabling than ME. It costs proabably $100,000++ to have people on benefits yearly.

 

[greeneagledown]

The medicine cost of a maintenance dose is not $5800 to $6800. It is more like half of that.




https://www.rheumatology.org/publications/hotline/0506newdrugs.asp


Maintenance dose = 500 mg.


Even though it would have been $6000 it would have been relatively cheap compared to other medicines. People get it for R.A, and other diseases that is less disabling than ME. It costs proabably $100,000++ to have people on benefits yearly.

If 1,000 mg = $11,643.80, then 500 mg = about $5,800, right?

And I believe OMI charges $6,800 per 500 mg dose just for the medication (that was on a different thread).

Regardless, it is definitely economically viable from a big-picture standpoint. Just not necessarily going to be an option for most patients until insurance agrees to pay for it.

 

[deleder2k]

$11,643.80 is a two dose start dose, i.e 2 grams. Standard schedule is up to 1 grams on day 0 and day 14. Then 500 mg every 3 months.