Would you try Rituximab?

[Effi]

I have spoken to numerous doctors about CD20 depletion, and almost everyone say it is a pretty "soft" drug compared to other drugs

That does sound promising... It's all very intrigueing and interesting, but I'm way too ill to really get into the specifics of this study. My lay brain is worried that depletion (or temporary complete erradication?) of B-cells could get us in trouble later on during the treatment when we catch e.g. the flu - won't our immune system be compromised/weakened so our ME will be under control but we'll be unsuccessfully fighting all sorts of other ailments? Maybe your well informed brain can answer this @deleder2k

 

[msf]

I hope the phase 3 study will give us information about the frequency of infection in the Ritux group vs the controls. Does anyone know if this was mentioned in the last placebo-controlled trial?

 

[ahmo]

I have spoken to numerous doctors about CD20 depletion, and almost everyone say it is a pretty "soft" drug compared to other drugs used for other deliberating diseases.

Yes, well...that statement gives me no comfort or confidence.

 

[Sidereal]

All I know is I wouldn't even be able to handle their pre-infusion drug combo of cetirizine, paracetamol and dexamethasone.

 

[sarah darwins]

I don't know whether I might feel differently if, like @snowathlete, I were still under threat of destitution due to welfare cuts, but I will reach state pension age next year.

That's definitely a component in my thinking. We're really short of money (well, in debt) and very concerned for what happens if my partner gets sick, which has happened before. It makes me willing to take more risks (and make compromises) for anything which offers a chance of serious improvement.

 

[Mary]

I totally agree. It is a valid claim. My point is that one can't compare side effects of a completely different drug and conclude based on that.

I have spoken to numerous doctors about CD20 depletion, and almost everyone say it is a pretty "soft" drug compared to other drugs used for other deliberating diseases. Since we don'r know what ME is, I think it is wise to be cautious, but if RTX works the way the researchers think I think the risk to benefit ratio is pretty clear. We would have to wait until phase 3 is published to be certain of the effect and side effects.

I don't trust doctors when it comes to "side" effects (actual effects) of drugs. Studies have shown that a majority are either ignorant of the effects or meds, or downplay them - in general they don't listen to their patients. I've known a couple of people who have had cancer and died, not from the cancer, but from the treatment. Statins are dangerous drugs and yet doctors hand them out without educating their patients, and the literature on statins and cholesterol from what I've read has been guided by the drug companies, not what is in the our best interests.

The potential side effects of RTX are quite severe: http://www.rxlist.com/rituxan-side-effects-drug-center.htm

Having said that, I'm well aware that ME can also be quite severe, and I totally get it for many to want to try it. Obviously none of us can decide for anyone else if they want to try it. I'm less sick than many here, although my life has been stopped for 17 years. Right now I have no wish to take RTX - I react so severely to meds, I can't imagine how I would react to this one.

The thing about RTX (as with most drugs it seems) is that it doesn't address the root cause - it addresses symptoms only and introduces its own set of problems. What we need to know is what is causing the problem with B cells, and of course this will take money and research.

So I'm afraid that research may focus on toxic drugs instead of trying to find out what's going on. After decades of focusing on chemo and radiation, very toxic therapies, cancer research is finally starting to focus on the immune system and how strengthening it can help defeat cancer. But it's taken decades to change the mindset. And I don't want us to have to go through that.

 

[deleder2k]

Yes, well...that statement gives me no comfort or confidence.

It shouldn't

But what should give you some comfort is that no serious side effects has been seen in any of the Rituximab trials done on ME so far. As mentioned earlier I'd recommend reading professor Jonathan Edwards' posts on the topic. He has used the drug for 20 years, and know the possible side effects better than anyone.

 

[deleder2k]

@Mary say that there was a 0.2% chance for a serious side effect if you got RTX. The chance of getting better is roughly 67%. Let's say 50% of those go into permanent remission. Would you not take it if those were the odds?

 

[Sidereal]

I've never been warned about any potential side effect of any drug I've ever been prescribed and even when predictable side effects developed it was usually vehemently denied that they could possibly be due to the drug.

 

[anniekim]

Ill for 17 years, been too ill to leave my home for last five years, the last two of which completely bedridden, use commode by bed, yes, I would try it

 

[catly]

I would go for it tomorrow--I fit the "auto-immune" subset profile with severe Hashimotos, + CCP, +ANA, sicca syndrome. Anxiously awaiting the phase II study results.

 

[Mary]

@Mary say that there was a 0.2% chance for a serious side effect if you got RTX. The chance of getting better is roughly 67%. Let's say 50% of those go into permanent remission. Would you not take it if those were the odds?

They sound like good odds; however, I don't see those odds anywhere. Here's what Simon posted:

"Two patients had an allergic reaction to rituximab and two had an episode of uncomplicated late-onset neutropenia. Eight patients experienced one or more transient symptom flares after rituximab infusions. There was no unexpected toxicity."

I'm wondering how they define "allergic" reaction - was this the potentially fatal infusion reaction noted in the black box warning?. Also, "uncomplicated" neutropenia? What does "uncomplicated" mean? If it tanks your white cells, you're going to be much more prone to infections. And no "unexpected" toxicity - so was there toxicity that WAS expected? The wording is so vague, it just sounds to me like they are downplaying any negative side effects. Maybe I'm being paranoid, but again, I don't trust the medical profession to be open and forthcoming about the dangers of drugs.

Here's what the official drug package insert says about some reactions: "The most common adverse reactions of Rituxan (incidence ≥ 25%) observed in clinical trials of patients with CLL were: infusion reactions and neutropenia" - so that's greater than 25%. More than 25% had their white cells tank, not a minor occurrence. And what exactly are these infusion reactions (potentially fatal) warned about in the black box warning?

The black box warning says in part:
FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
Infusion Reactions
Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Severe Mucocutaneous Reactions
Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Hepatitis B Virus (HBV) Reactivation
HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

 

[Mary]

@deleder2k - if I were bedridden and as sick as many on this board, I would probably try it. But I have made progress in the last 10 years, albeit very slowly, but progress. And I continue to experiment on my own (e.g., am currently using a homeopathic remedy in an attempt to modulate my immune system) with things I deem safe.

You know, if you're in a burning building, you may very well jump, as the odds of surviving may be better that way. but for me right now the risk is not worth it (the jump to rituximab). For many, however, it will be worth it, and I would never try to convince them otherwise.

 

[ahmo]

if I were bedridden and as sick as many on this board, I would probably try it. But I have made progress in the last 10 years, albeit very slowly, but progress. And I continue to experiment on my own

I'm in your camp.

 

[deleder2k]

@Mary

Reading of some random web page with side effects doesn't say much about the risk for treating ME. Look up some meta studies on PubMed for R.A and see the incidence of side effects. We should leave this field to doctors that have worked with this drug. That knows the side effects. I think it is hard to fully understand how the drug works, potential side effects, etc. without having studied some medicine at all. It is complex. Very complex.

I am not sure what you mean about "tanks your B-cells". A minor decrease in IgG levels is common, but it usually has no impact on infections. If your IgG levels get too low (which is rare), you'll get an infusion of humane gammaglobulins. When looking up side effects, I don't think CLL is representative for ME treatment. Nothing is really, but I would guess that looking at some R.A studies would give you a clue of possible side effects.


I'm not a M.D, so this isn't really my table, but as I've mentioned earlier; read professor @Jonathan Edwards' posts on this.

 

[Sushi]

Note: this is the second poll on "Would you take Rituximab," if some of this seems a bit deja vu. The first poll has one more choice in it so I don't know if it would work to merge the threads. It is here.

 

[deleder2k]

Note: this is the second poll on "Would you take Rituximab," if some of this seems a bit deja vu. The first poll has one more choice in it so I don't know if it would work to merge the threads. It is here.

Interesting to have a look at it! We do know much more now than we did 3 years ago though. I would imagine people being less skeptical now than a few years ago.

 

[Misfit Toy]

With having CVID a primary immune deficiency, Sicca or Sjogrens (autoimmune) and unable to take IGG to balance out the CVID, the answer from me is nope. Actually, "no way." My rheumatologist would love for me to be on it, but having the reaction to IGG that I did, it's not going to happen and he is adamant about that, too. It could be a grenade for me. Plus, I have MCAS probably due to this creepy and crazy immune system that attacks everything.

I am not thoroughly convinced of it (ritux) anyway....at least not for helping everyone. Clearly, it doesn't do that. So, again....if only they could unravel all subsets of people and get to the bottom of it for all of us. But...that's asking a lot.

So, I will just keep going along and waiting for more research, more trials, more findings....over the DECADES....LOL. I remember when Ampligen was the holy grail that everyone wanted...I guess this is the next big thing. Wonder what will be next and will it be approved for CFS?

 

[SOC]

I'm with @deleder2k on this. I think the consequences of the ME itself are so high that the relatively minor risks of Ritux are worth it.

However, I think this kind of thing is a very personal decision, as any risk-assessment situation is. Some people have more to lose than others. Some people are more risk-averse than others. There's just too many variables for there to be one right answer for everyone.

 

[Marky90]

I would advice all the sceptics to read up on the adverse effects. They are really really rare. I would take ritux in a heartbeat.