Is there any way I can be treated with rituximab privately?

[Mariah]

I just have a question regarding the dosage of Rituximab, and was hoping @Jonathan Edwards could answer me.

At Kolibri, the Norwegian clinic that treats ME-patients with Rituximab, the two first doses are at 1 g each with follow up doses at 500 mg. At the Haukeland trials my understanding is that the dosage was determined individually for height and weight. So I was wondering if the differences in dosage, with Kolibri`s being higher, could affect the outcome and the overall respons? I understand that it would certainly affect the amount of side effects and who has an increase in their ME-symptoms, which are far higher at Kolibri than at the trials. But could it also affect the response, could the amount of people responding somehow go down, the response disappear for some who would otherwise respond at a lower dosage, or the response get worse with this increase in dosage? I know this may be a dumb question, but in many other diseases it`s often a question of the right dose rather than the highest dose.

 

[Jonathan Edwards]

I just have a question regarding the dosage of Rituximab, and was hoping @Jonathan Edwards could answer me.

At Kolibri, the Norwegian clinic that treats ME-patients with Rituximab, the two first doses are at 1 g each with follow up doses at 500 mg. At the Haukeland trials my understanding is that the dosage was determined individually for height and weight. So I was wondering if the differences in dosage, with Kolibri`s being higher, could affect the outcome and the overall respons? I understand that it would certainly affect the amount of side effects and who has an increase in their ME-symptoms, which are far higher at Kolibri than at the trials. But could it also affect the response, could the amount of people responding somehow go down, the response disappear for some who would otherwise respond at a lower dosage, or the response get worse with this increase in dosage? I know this may be a dumb question, but in many other diseases it`s often a question of the right dose rather than the highest dose.

As far as we know there is no 'too much' rituximab dose. Side effects are not related to dose - they tend to occur early on with the start of the first infusion if at all. From other autoimmune diseases it looks as if the dose is not very critical - it is quite likely that we are giving more than many people need. On the other hand a half dose does not seem quite as good. I wouldn't get worried about dosage at all to be honest. The Kolibri dose is the one I devised for RA, for the sake of simplicity. The Haukeland dose may be a bit less for small people but will be about the same for heavy people.

 

[Mariah]

Thanks @Jonathan Edwards, good to know! It seems to me that a worsening of symptoms, if not directly side effects, is more prevalent at Kolibri. But I guess there is no way to know why that is, one guess is there are many more people at Kolibri than at the Haukeland trials.

 

[deleder2k]

@Mariah, I don't think you can draw that conclusion from a poll on Facebook. The question is somewhat like "How many suffered a worsening of two weeks or more after their first infusion". If you asked patients treated at Haukeland same question I think you would probably have an answer that is pretty much the same. As previously mentioned almost the same amount of patients in the placebo group reported side effects after infusion in the study from Haukeland published in 2011.

One thing that can differ is that The Kolibri clinic has patients from all over the country. I think most of their patients are travelling from all over the country. The majority of them by plane, or 8 hours of travel by train or car.

Based on what we know there is no reason to say that we are seeing an increased frequency of side effects at the Kolibri Clinic.

 

[Mariah]

Really don`t know which poll you are talking about @deleder2k, as I haven`t seen any poll (and what I feel about you both being a patient at the trials and an admin of such a group for private treatment I will keep to myself, but I find it highly unethical considering the quality of the studies). I talk to many of the patients, and a large number of them have had a worsening that is long-term, well over two months, and gets worse with every infusion. Some say they have never been as sick as they are now. These may not be side effects so to speak, but a worsening of the illness itself which is way beyond what you get from travelling. I am not claiming my experiences to be of scientific quality, but these many people getting that much worse? I find it a little strange.

 

[deleder2k]

The only thing that I can think of (except the physical cost of travelling) is that Kolibri use a higher infusion speed than Haukeland does. Fluge and Mella thought that decreasing the speed of infusion could lead to less side effects.

I think Kolibri keeps a record of side effects. I guess the best bet to find out more about this is to call them and ask. Perhaps they will reveal the information.

 

[Joolz]

Giving subcutaneous rituximab is completely pointless if you understand what the point of giving rituximab is - the idea is to produce complete B cell depletion as rapidly as possible. At least if you give all the drug in an infusion centre you cover the single period of high risk adequately. If you gave it daily the patient would have to attend the centre every day or be an inpatient. Giving subcutaneously does not alter the range of reactions you can get as far as we know - it just makes it more difficult to know when they might manifest. Adverse reactions appear to have nothing much to do with the dose given - the acute reactions occur with the first few milligrams and the later reactions probably occur however you divide the doses.

I do not mean to be rude but ideas like this based on a misunderstanding of the pharmacodynamics of the treatment are exactly the sort of extra hazard I worry about if people go for private treatment!!! Even the drug companies do not understand how there drug is working so are developing inappropriate ideas like this. Inexperienced physicians are very likely to think they have a clever idea about a better way that is in fact more dangerous. Serious adverse events were much more frequent when the drug was first used because people did not understand what they were doing.

Do I understand you correctly that Rtx will not be equally efficient if given to CFS patients subcutaneously? I heard rumors that the next Rtx trial (i.e. an open-label trial for those who are receiving placebo in the current phase III trial, given that the latter is succesful) will involve subcutaneous instead of intravenous Rtx. Any opinion on this?

 

[Jonathan Edwards]

Do I understand you correctly that Rtx will not be equally efficient if given to CFS patients subcutaneously? I heard rumors that the next Rtx trial (i.e. an open-label trial for those who are receiving placebo in the current phase III trial, given that the latter is succesful) will involve subcutaneous instead of intravenous Rtx. Any opinion on this?

Rtx can almost certainly be given subcutaneously but my concern is the side effects. With IV you give it very slowly to start with and you can stop the drug immediately if there is a reaction. With subcutaneous the drug is already under the skin and you cannot stop more drug getting into the circulation. The drug companies are very keen on subcut but I cannot see why. Another anti-CD20 has been developed subcut and late reactions (i.e. at night when the patient has got home) were a problem as I understand it.

 

[ebethc]

I have discussed RTX with Dr. K at OMI but at present, it is not something that I am going to pursue. We do not think I could tolerate it due to MCAS/potential allergic reaction in addition to the amount of IV fluid that it would require.

Is RTX contra-indicated w MCAS? why?

ETA: Truthfully, I do not think they know yet who is going to be a responder. I am highly IgM positive for 2+ years for EBV virus which put me in the group that they would consider giving it to but I really do not know much more beyond that. Others may be able to provide more info.

My IgM for EBV is normal; do a normal IgM mean that a person is not a good candidate for RTX?

 

[Gingergrrl]

Is RTX contra-indicated w MCAS? why?

@ebethc The post you quoted me from was a year ago and I have a lot more information re: my own case now (which may or may not pertain to you). I now know that I have eleven auto-antibodies so my desire to reduce them and improve my symptoms now overrides my fear of an allergic reaction to RTX. I would not say that it is contra-indicated in MCAS and no doctor has told me this. But like anything else, something like RTX could potentially cause an allergic reaction in MCAS and I'd go in knowing this risk (if I decide to do it in the future). I would have to be pre-medicated with steroids, H1 and H2 blockers, etc, above and beyond the average person even though my MCAS is currently in remission.

My IgM for EBV is normal; do a normal IgM mean that a person is not a good candidate for RTX?

I honestly have no idea re: this question. I believe that EBV hides out in the B cells so one benefit of RTX could be to kill (lower?) the EBV. In my case though, it would be to lower all of my auto-antibodies and for the first time in many years, I am no longer IgM+ for EBV (but I suspect this could fluctuate back at any time). I really have no idea who is a good candidate for RTX and am not sure if anyone knows. Only that if it can kill or tamp down my auto-antibodies, I am willing to try it if given the opportunity.

 

[Jeremy C.]

People use Facebook forums. In Norway the main one has 3000 members. 4-500 active everyday.

@Marky90 Could you provide a link to this forum? I can't find it.

 

[ebethc]

@ebethc
I believe that EBV hides out in the B cells so one benefit of RTX could be to kill (lower?) the EBV.

I think this is true...( I may have read it somewhere) This is the main reason that I think RTX could help..

How are the side effects from RTX? I haven't read too much, but it does sound awful. I have taken things that have made me worse, and it's a terrible feeling b/c you did it to yourself

 

[Gingergrrl]

@ebethc I have never tried RTX and have no idea what side effects I'd have but my biggest fear at the outset is always anaphylaxis. I have not researched the side effects in detail b/c really focused on IVIG now. But if RTX becomes a reality, I will learn everything there is to know!

 

[ebethc]

@ebethc I have never tried RTX and have no idea what side effects I'd have but my biggest fear at the outset is always anaphylaxis. I have not researched the side effects in detail b/c really focused on IVIG now. But if RTX becomes a reality, I will learn everything there is to know!

Is IVIG helping?

 

[Gingergrrl]

Is IVIG helping?

I started with a very low dose (24 grams) and it has put my mast cell disease into remission and I am able to eat regular foods, tolerate smells, and have had no allergic reactions for months. I am calling it a remission b/c I have no idea if this is temporary or permanent but I feel it has shifted my immune system away from the allergic reactions and I no longer fear anaphylaxis from food.

However, the actual autoimmune starts at approx 55 grams for me and I have not yet had the opportunity to try it. We started low to be safe (b/c of my MCAS and possible other reactions and b/c this was all my insurance would allow). This Fri & Sat I am finally trying the 55 grams in a two day split dose by pooling my remaining infusions together. So, I will get to see how I tolerate this but it leaves me with nothing left and the insurance auth is over. My main doctor along w/my MCAS doc are going to advocate that I get to try the higher dose for at least six months.

I have eleven known auto-antibodies and the hope is that the higher dose will lower them and in turn improve my breathing and muscle weakness. So until I try the higher dose, I really cannot comment but the lower dose improved my MCAS beyond my wildest dreams. So if the higher dose could even allow me to walk around my apt without the motorized wheelchair, I will be thrilled. Am just hoping my insurance will allow me to do it (and that I tolerate the higher dose!) but am doing the pre-meds, the very slowest infusion speed, etc, to increase this chance.

 

[ebethc]

My main doctor along w/my MCAS doc are going to advocate that I get to try the higher dose for at least six months.

is this something that you can administer at home, or do you have to have a doctor do it?

 

[Gingergrrl]

is this something that you can administer at home, or do you have to have a doctor do it?

You can do with home health but I do at an infusion center connected to a hospital b/c of my allergic risk, pulmonary edema risk, etc. it is safer for me that way but many do it with home health with no problems.

 

[ebethc]

The adverse events can be immediate or occur later - days, weeks, or years later.

what kind of adverse effects can occur later? PML?

 

[L Y]

I think you'd have to look at geriatric pharmacology to get the idea of the ME possible response. (It is unfortunate that Naviaux (sp?) used the metaphor of dauer to describe his recent study - the metabolomics discovered seem to have much more in common with geriatric studies. https://www.ncbi.nlm.nih.gov/pubmed/15169926

 

[eljefe19]

Has anyone here travelled to Norway for Rituximab treatment?
I am curious what the experience was like and whether it's worth traveling 10-15 hours to save a few thousand dollars.