Is Anyone Else Scared of Rituxan?

[Misfit Toy]

I've had times in the past when I thought things couldn't get any worse and toxic drugs were worth the risk but in the end all drugs I ever took (ironically, very few overall) made me worse. With this illness, there always exists the potential to sink to previously unimaginable depths of illness. I don't think even mild or moderate ME patients can comprehend the special hell of severe/very severe ME. I think that at present, in the absence of solid prognostic factors for a good response to rituximab, it's too risky (as evidenced by experiences of German patients) but in the future if the pathophysiological mechanisms are elucidated a bit more I think it's worth considering.

Perhaps my view is skewed by the fact that I've been at this for 20+ years so the gung-ho attitude of my earlier years is long gone. In the first few years of being sick with this freakshow it seems impossible/intolerable to comprehend or imagine a future in which every day looks like this for decades so I think people naturally think the best approach is to do whatever it takes to get better but I think the experience of many long-term patients has been that many "treatments" make things worse ultimately. Sometimes preserving what little functionality is left is a better approach than taking huge risks. In ME, a gamble can result in things like severe intractable pain 24/7 and inability to assume even a sitting position for more than a few minutes. Continuing for months or years.

Sidereal...I love this. It says it all. All that I feel.

 

[Kyla]

The thing is, regardless of whether one is interested in taking Rituximab, I think a positive trial will still help all of us, for the following reasons:

1) it will give researchers clues as to what is going on in the disease, (and clearly already has started to do so), opening up further avenues for research

2) the way Rituximab works can suggest other treatments (and this is clearly also already happening, with Fluge and Mella doing simultaneous small trials of another B-cell depleting drug)

3) having a proven effective drug will make research into ME/CFS more appealing for drug companies and potentially other sources of funding.

4) It will be one more very large, hard-to-ignore nail in the coffin of the BPS viewpoint. It will be very hard to spin the success of a large double-blind drug trial, though I am sure they will still try their best.


So whether you want to try Rituxan or not, i would say supporting this research benefits all of us. Just my 2 cents.

As to whether Rituximab is worth trying, I think that it will be much easier to assess the risk vs. reward when the trials are done and published, and we can see what the response rate is, whether it is longterm, any adverse events etc.

Based on what we have seen so far I think I would try it - If I could afford it.

 

[Misfit Toy]

Good points, @Kyla ....the if you could afford it part; so true. Like ampligen.

 

[msf]

That's interesting, Prof. Edwards. I realized that many drugs were requisitioned (if that's the right word) for diseases without having a specific target in my mind, but I guess I thought the rules for drugs like Rituximab might be different. I guess efficacy and safety are the only things that really matter, although I think long-term safety may be compromised when the theoretical basis for use is not well-established.

 

[dannybex]

I am interested to know where that list comes from. It bears no relation whatever to the side effects of rituximab! Maybe it comes from a site written by someone who is not too keen on the idea of using the drug?

Here's the site where I found the list I posted:

http://www.rxlist.com/rituxan-side-effects-drug-center.htm

But there are more here:

http://www.drugs.com/cdi/rituximab.html

…and also on the drug manufacturer's page:

• Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. Your doctor may give you medicines before your treatment to help prevent TLS
• Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful
• Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. Your doctor may need to stop your treatment
• Kidney Problems: your doctor should do blood tests to check how well your kidneys are working
• Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom
• Low Blood Cell Counts: your blood cell counts may be monitored during treatment

The most common side effects of RITUXAN are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.

http://www.rituxan.com

 

[adreno]

For most patients rituximab has no side effects.

Many of us get side effects just from taking vitamin C.

 

[dannybex]

My point is that just looking at the side effects doesn't give you much information about the real side effects from the drug. Haukeland University hospital have treated about 30+ patients with Rituximab, and they have not discovered any serious side effects.

Good point.

The data we have so far is that 2/3 are classified as major responders, i.e many return back to full-time work, are able to engage in sports, able to work, able to travel, able to get out of their bed. If I am not wrong, average level of functioning after RTX for major responders is almost 80% (Where 100% is completely healthy). It looks that around 50% relapses after 6 infusions.

It's my understanding however that the improvements are 'generally transient'. At least that was the conclusion of the 2011 study, wasn't it? If so, I'd be worried that I'd have to take the drug for the rest of my life, and in doing so would be setting myself up for problems due to immune system suppression, among other things.

We certainly don't have the knowledge of how Rituximab works in PWME yet, but I am having trouble understanding why so many here are so skeptical. It is a drug that have been used for many, many years in conditions which comes nowhere near ME in how it affects life quality. We can only hope that the results will be just as good when the Phase 3 study is published in 2017/2018.

I'm skeptical for several reasons, but one of the main ones is the one you expressed -- that they don't know how it works in PWME. I also don't understand what you're saying about it being used in conditions "which comes nowhere near ME in how it affects life quality". I trust you're not suggesting that quality of life for ME patients isn't as severe as most other illnesses.

???

 

[JPV]

We certainly don't have the knowledge of how Rituximab works in PWME yet, but I am having trouble understanding why so many here are so skeptical.

Really, you're having trouble understanding why a person afflicted with ME/CFS, which has no definite diagnosis and numerous different subgroups, many of which are suffering from various comorbid chronic infections, are leery of taking a drug that knocks out a part of their immune system? And, as you've admitted, doctors have yet to offer a valid theory as to why they think it might work for some people and not others. Seems perfectly reasonable, to me at least, for people to be cautious under these circumstances.

 

[deleder2k]

Good point.



It's my understanding however that the improvements are 'generally transient'. At least that was the conclusion of the 2011 study, wasn't it? If so, I'd be worried that I'd have to take the drug for the rest of my life, and in doing so would be setting myself up for problems due to immune system suppression, among other things.


I'm skeptical for several reasons, but one of the main ones is the one you expressed -- that they don't know how it works in PWME. I also don't understand what you're saying about it being used in conditions "which comes nowhere near ME in how it affects life quality". I trust you're not suggesting that quality of life for ME patients isn't as severe as most other illnesses.

???

The improvements were "generally transient" in the first study as you correctly say. Most of the patients relapsed. In 2011 study the participants were only given 2 infusions. In the open study that will be published now patients received 6 infusions. Some results were released from the study in an application to the Norwegian Research Council. If you look for it, it should be available here somewhere under the Rituximab section.

You can trust me on that. Sorry if I was unclear; I meant that ME is more severe than many other diseases where one use "hard" drugs.

 

[Folk]

I think people are losing the track here.

The question is "Is anyone else scared of Rituxian?"

And the simple answer is Yes, probably every PWME is. I know I am REALLY scared.

I'm scared of trying Keto Diet (or any other type of diet) for gods sake.

The simple thing is. Is it worth the risk? That's up for each patient to decide.
And to do so, the best way, as always, is to gather information. But go for the legit information, not the side effects list.

Read the list of side effects of any med, ANY med, and you'll drop it. So, wether you go and try homeopathy and then wait for the Placebo God to be on your side or you try things that can help you for real.

Still, I am pretty scared too and I feel you.
But hey, aren't you scared of just how will you wake up tomorrow?

 

[lansbergen]

I am not scared but I decided it is not for me. That still stands.

 

[deleder2k]

Really, you're having trouble understanding why afflicted with ME/CFS, which has no definite diagnosis and numerous different subgroups, many of which are suffering from various comorbid chronic infections, are leery of taking a drug that knocks out a part of their immune system? And, as you've admitted, doctors have yet to offer a valid theory as to why they think it might work for some people and not others. Seems perfectly reasonable, to me at least, for people to be cautious under these circumstances.

As far as I'm concerned, this seems more like trying to "fit a square peg in a round hole" in order to find a new target group to become consumers of a very expensive drug.

As of today there are no real evidence that shows that chronic infections plays a vital role in ME.

To my knowledge, patients with chronic infections has not been an issue in any of the studies. If people do suffer from chronic infections, they shouldn't get Rituximab as far as I am concerned.
The 2011 study was delayed because the researchers spent a year at the lab to rule out XMRV. They take this issue very seriously. They only include patients that fit the Canadian criteria.

I am not sure if you're trying to imply that the researchers or Roche are trying to find a group of patients so that they can earn money on us with a drug that is harmless or not even effective. Remember that the multi-centre trial is funded without the drug company at all. That is very unusual for phase 3 studies.
The researchers in Norway has been doing this the right way from beginning. They let their papers that they publish speak for themselves. They haven't claimed that they know what ME is, they haven't claimed they have one solution for us, nor that patients should be given RTX before the study is completed. In fact they have urged doctors around the globe to not use RTX for PWME as of now.

We will simply have to wait. I understand that patients are skeptical against trying Rituximab before the multi-centre trial is published. Only then do we know the results.

I just don't get people saying that they do not want to try Rituximab at all after reading a random web page where side effects are listed.

 

[deleder2k]

I think people are losing the track here.

Read the list of side effects of any med, ANY med, and you'll drop it. So, wether you go and try homeopathy and then wait for the Placebo God to be on your side or you try things that can help you for real.

But hey, aren't you scared of just how will you wake up tomorrow?

That is a legit question. How will you wake up tomorrow? What does ME do the body? To the bones? To the cardiovascular system? What about the risk of developing B-cell cancer?

What are the side effects of having ME?? How dangerous is it? One could claim that it would be more dangerous to have ME than to stop it with drugs that are well-tested (at least Rtx will be in 2017).

 

[halcyon]

As of today there are no real evidence that shows that chronic infections plays a vital role in ME.

There is no conclusive evidence, but there is evidence. Just like there's no conclusive evidence that rules it out.

 

[deleder2k]

There is no conclusive evidence, but there is evidence. Just like there's no conclusive evidence that rules it out.

But as I said; if a patient suffer from an active chronic infection they shouldn't get Rituximab.

 

[JPV]

To my knowledge, patients with chronic infections has not been an issue in any of the studies. If people do suffer from chronic infections, they shouldn't get Rituximab as far as I am concerned.

I'm not an expert in the things but I see a lot of talk, on this forum, about dozens of potential infections that many of us might have and some of them have proven to be very difficult to detect. How can their be any assurance that these hard to detect infections will be screened properly?

As of today there are no real evidence that shows that chronic infections plays a vital role in ME

Again, we're talking about a condition with various subgroups...

WHAT IS INFECTION-ASSOCIATED MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME? (Stanford University)

At Stanford, we believe that a subset of cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) may be related to infection. The nature of the association is still unknown, but we use two possible hypotheses in our research. One hypothesis is that the symptoms of ME/CFS could be triggered by the persistent activity of a pathogen (for example, a bacteria or virus) in the patient. However, the second hypothesis is that the symptoms of ME/CFS may be caused not by the pathogen itself, but rather by the body’s immune response to the pathogen.

 

[JPV]

I just don't get people saying that they do not want to try Rituximab at all after reading a random web page where side effects are listed.

Well, when one of those side effect is death, people justifiably get scared.

Sorry, but I feel compelled to ask this. Maybe you've addressed this before but is there any sort of conflict of interest that you should declare regarding Rituximab or the current trials?

Seems that the vast majority of your posts are about Rituxmab. You're always very defensive about it even though there hasn't been much conclusive proof regarding it's long term effectiveness in treating ME/CFS. You also seem to have a lot of inside information about the trials that doesn't really appear anywhere else online.

 

[deleder2k]

I am just a patient that wants to get back to life. As I said many times; we do not know for sure before the multi-centre study is published in 2017. But I am pretty sure that immunomodulatory drugs can help a group of ME patients. We don't know how many patients that will respond yet. We have signs that a group of PWME suffers from some sort of autoimmune disease. When we also know that patients have become substantially better by MTX, Cyclophosphamide and Rituximab, I think it is fair to be an optimist about the stuff they are carrying out in Bergen, Norway. Everyone can decide for themselves, but it would be an understatement to say that the autoimmune lead is somewhat interesting in terms of treatment.

I have no real inside information about the studies. I speak Norwegian, and I use google a few times a week trying to dig up new information to check for patent applications submitted, applications to the Research Council of Norway, and correspondence between hospitals and governmental agencies. The general rule is that all correspondence by governmental agencies are publicly available in Norway. I have also chatted with numerous of patients that havs been participating in the RTX trials, and lastly also in the new cyclophosphamide trial.

 

[deleder2k]

And just to add: I am interesting in getting better by the disease. That is my main concern. That is why most of my points are about MTX, RTX, Cyclo, and Nitro. As of now we don't have a lot of other drugs that has shown a great effect on PWME in blinded studies, or have we?

 

[JPV]

@deleder2k, Thanks for the clarification.

Are you trying any of the other interventions proposed on this forum and have any of them been beneficial in alleviating your symptoms? I seem to remember that you tried Freddd/Rich's methylation protocol but it didn't seem to work for you. If it's any consolation, it didn't benefit me much either.

I seem to be getting a moderate amount of relief from a combination of Clostridium butyricum, Turmeric/Curcumin and TUDCA. I've come to the conclusion that inflammation seems to be playing a big part in my condition. I doubt that it's the root cause but at least I can minimize some of the symptoms until something better comes along.