Is Anyone Else Scared of Rituxan?

[deleder2k]

I am not sure what that has to do with my question.

I have not recommended it to anyone. No one should listen to a random guy on PR. They should listen to what studies, the FDA, the EMA and their health care professional say.
I'm just a patient who would like to get healthy again.

 

[JPV]

It seems that some have decided already not to ever take it because they see some random web page list up side effects that sound scary.

Death is just a "scary" sounding "side effect"?

My goal is that everyone makes informed decisions about this drug from people that have worked with the drugs for years, especially @Jonathan Edwards, or from large studies conducted - not from unreliable web pages without references for their claims.not from unreliable web pages without references for their claims.

Are you also saying that the Wall Street Journal article, that I posted excepts from earlier in this thread, is just some "random" and "unreliable" website?

FDA Weighs the Risks of Rituxan (The Wall Street Journal)
Drug for Treating Lymphoma Is Linked to Cases of Fatal Brain Disease

A study released in March in the medical journal Blood linked Rituxan to 57 cases of progressive multifocal leukoencephalitis, or PML, between 1997 and 2008.

In PML, the white brain matter decays, provoking memory loss, speech disorder and disorientation. Charles Bennett of Northwestern University and colleagues have been collecting cases in a study called Radar, which identified the 57 PML cases. Of those, 51 died. The median time between their diagnosis and death was about two months.

The cancer doctors at Northwestern who published the article in Blood suggested that the FDA should restrict use of Rituxan in patients who don't have life-threatening disease until more is learned about PML.

"This drug isn't aspirin, and shouldn't be given willy-nilly to patients who don't have a fatal disease," said Dr. Bennett.

 

[deleder2k]

@leokitten, what about trying a low dose? Like 1g a week? That shouldn't cost more than $400-500 a month. Some have reported benefits with that schedule. A women from the film "Perversely Dark" was bedridden before she took it. Now she can work, use her bicycle and she is also politically active. The other person in the film did not respond.
A doctor in Norway has been giving 5ml of Gammanorm (0.825g/week) to approximately 60 persons or so. She said that 50% responded. Some had a moderate response, while some others experienced a major response and are now back at work/studies. It is anecdotal, but it is still very interesting. We know that IVIG are used in some autoimmune diseases.

 

[leokitten]

The risk of getting PML after rituximab is approx 1 in 25,000 individuals, so it's somewhat rare.

Rituximab-Associated Progressive Multifocal Leukoencephalopathy in Rheumatoid Arthritis

 

[leokitten]

@leokitten, what about trying a low dose? Like 1g a week? That shouldn't cost more than $400-500 a month. Some have reported benefits with that schedule. A women from the film "Perversely Dark" was bedridden before she took it. Now she can work, use her bicycle and she is also politically active. The other person in the film did not respond.
A doctor in Norway has been giving 5ml of Gammanorm (0.825g/week) to approximately 60 persons or so. She said that 50% responded. Some had a moderate response, while some others experienced a major response and are now back at work/studies. It is anecdotal, but it is still very interesting. We know that IVIG are used in some autoimmune diseases.

Thanks for the recommendation, I'm willing to try anything in order to have my life back.

The thing though for treating autoimmunity with IVIG you typically go much higher than the hypogammaglobunemia dosage, so even more expensive. But if people have had improvement with low dose I'm willing to give it a try.

 

[deleder2k]

@JPV, I am not referring to you or no one specifically in this thread. In the study outline for RituxME the chance of PML was said to be 1:20 000. I think the general consensus is that the chance is lower. The occurrence of PML is also higher in individuals with cancer, lupus and HIV that have not received Rituximab. I don't know if the chance of PML is higher in people with R.A compared to healthy controls.
It looks however that Rituximab increases the chance of developing PML:

This study looked at PML in patients treated with Rituximab and R.A.

Results
Four patients from an estimated population of 129 000 exposed to rituximab therapy for RA are reported in whom PML developed after administration of this drug. All were women older than 50 years, commonly with Sjögren syndrome and a history of treatment for joint disease ranging from 3 to 14 years. One case had no prior biologic and minimal immunosuppressive therapy. Progressive multifocal leukoencephalopathy presented as a progressive neurological disorder, with diagnosis confirmed by detection of JC virus DNA in the cerebrospinal fluid or brain biopsy specimen. Two patients died in less than 1 year from PML diagnosis, while 2 remain alive after treatment withdrawal. Magnetic resonance scans and tissue evaluation confirmed the frequent development of inflammatory PML during the course of the disease.

Conclusion
These cases suggest an increased risk, about 1 case per 25 000 individuals, of PML in patients with RA being treated with rituximab. Inflammatory PML may occur in this setting even while CD20 counts remain low.

I do not know much about PML, but if the risk is less than 1:20 000 I would think the benefits would outweigh the risks if phase 3 is positive. The question would of course be how many more patients with ME would get PML with after Rituximab compared to the average person with ME.

Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428054/

 

[JPV]

The risk of getting PML after rituximab is approx 1 in 25,000 individuals, so it's somewhat rare.

True, but this study was in reference to using it to treat Rheumatoid Arthritis, not ME/CFS. There are certainly other characteristics of ME/CFS, such as various co-infections and gut issues, that might complicate matters even more.

From the "random" and "unreliable" Mayo Clinic website...

Rituximab (Intravenous Route)

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain), history of or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia), history of or
• Hepatitis B or
• Infection (eg, bacteria, fungus, or virus) or
• Kidney disease or
• Lung problems (eg, asthma, bronchitis), history of or
• Stomach or bowel problems (eg, intestinal blockage, perforation, ulcers)—Use with caution. May make these conditions worse.

 

[deleder2k]

@leokitten, yep. It is strange. I don't know why it works for some. It is a very low dose, but it seems to be beneficial for a sub group. The doctor is trying to start a study with gammaglobulin in Norway. I hope she will be able to conduct it.

 

[Marky90]

It is so expensive and not covered by insurance unless you have proven hypogammaglobunemia, which I don't have. My IgG levels and subclasses have always been good, yet my immune system is constantly having trouble controlling intracellular pathogens, in my case very high antibodies to EBV, CMV, HHV-6, M pneumoniae, and C pneumoniae.

I really don't think this is an infectious disease because i have been taking aggressive and targeted therapy against all these pathogens for over 1.5 years and I don't feel better. I have terrible circulatory problems like my body cannot control blood flow to parts of my body and I know for sure this is the root problem with me that this is causing all the other symptoms (fatigue, PEM, GI and genitourinary issues, cognitive dysfunction, muscle pain, etc).

I really think Fluge/Mella are on the right track and that many of us are in this subgroup with some kind of autoimmunity causing endothelial dysfunction resulting in poor blood flow to all our organs.

Right when I got sick I had a sudden and drastic tissue loss in those first 6 months particularly from my extremities, my shoe size went from 11 to 9, my hair started falling out like crazy and changed texture to become thin and unhealthy looking, it started going grey very quickly. I lost tissue basically everywhere and muscle even though I'm not deconditioned I move and walk around a lot and as I've said can still work full time.

ME/CFS never gave me OI or POTS it actually made my blood pressure and volume go up, I've had mutiple blood volume analyses via Daxor, my blood volume is way too high not low but I do not have any heart failure or kidney problems. My heart rate also became very low always in the low 50s which is what you would expect if your blood volume has gone too high.

Something is wrong with our vascular system this is the root cause for my subgroup.

I also get heightened diastolic pressure and low 50s heart rate. I view my condition as very probable autoimmune, no infections, just bizarre fatigue and orthostatic issues. Im hopefully starting IVIG very soon, and will get back to you on how that goes

 

[Sushi]

The reason I am positive about it is because it is our greatest hope in terms of treatment for PWME - ever.

If you read the tweets from today's conference and follow the other ongoing research, there is quite a lot of promising research some of which is already available as treatment = Dr. Chia's treatment of enteroviruses.

Sushi

 

[dannybex]

The point is that without scientific studies, you cant know for sure that recoveries/remisssions are due to treatment X. Maybe the person using the treatment can be sure, but this is of no great use for the rest of the patient group.

If you check some of the other sections on PR, you'll find that in fact it is.

I really do think it is very important to try out the treatments based as much as possible on studies which can be found on Pubmed, as mentioned in my earlier post.

And i would like to add - some people did indeed take one remedy and recovered - with Rituximab.

Perhaps you've never heard of Valcyte:

http://dominatufatigacronica.com/bl...ment-of-142-herpesvirus-patients-with-CFS.pdf

"Long-term valacyclovir and/or valganciclovir subset-directed administration improved or eliminated CFS symptoms in Group A CFS patients, allowing them to return to normal life."

 

[Sushi]

Honestly I cannot wait until the RituxME trial is complete so that I can try it.

Have you investigated taking it with Drs. Kogelnik and Kaufman, as they are giving it to some patients now?

Sushi

 

[leokitten]

Have you investigated taking it with Drs. Kogelnik and Kaufman, as they are giving it to some patients now?

Sushi

OMI is giving people rituximab if they want it, but it's not covered by insurance and it's extremely costly, something close to $10k total cost per infusion. I just don't want to shell out that kind of money until we find out for sure from the RituxME and UK Rituximab RCTs which subgroups get remission and which get worse.

I have a hunch I'm in the subgroup that will get remission from rituximab but I just have to wait like all of us and try to keep my disease from getting worse until the data is there.

 

[Undisclosed]

If you read the tweets from today's conference and follow the other ongoing research, there is quite a lot of promising research some of which is already available as treatment = Dr. Chia's treatment of enteroviruses.

Sushi

I didn't tweet this but a woman in the audience with ME said she would try Rituximab no matter what the side-effects if the possible outcome was feeling better. The research by Fluge and Mella has also demonstrated that patients are not quitting the trials due to side-effects.

 

[Sushi]

OMI is giving people rituximab if they want it, but it's not covered by insurance and it's extremely costly, something close to $10k total cost per infusion.

It may have changed but I don't think that some of the patients here who posted about getting Ritux infusions from OMI paid for more than the infusion costs, not the drug itself. Hopefully some of them will clarify this point.

 

[dannybex]

I don't want anyone to take RTX before phase 3 is completed, and not before the FDA/EMA approves it.

FDA approval? Then I guess we should check back around 2027?

I am just trying to balance the view about this drug. It seems that some have decided already not to ever take it because they see some random web page list up side effects that sound scary.

Like the manufacturer's own website?

http://www.rituxan.com

People have every right to be skeptical about it, and for many patients it won't be the solution. My goal is that everyone makes informed decisions about this drug from people that have worked with the drugs for years, especially @Jonathan Edwards, or from large studies conducted - not from unreliable web pages without references for their claims.

As mentioned earlier, many of the things other members have tried are backed up by studies on Pubmed.

The reason I am positive about it is because it is our greatest hope in terms of treatment for PWME - ever. No randomised trial for any drug have provided the same results. We are still years before we know if this will be a solution for a sub group of PWME.

Again, I would say 'decades' rather than years, that is if you're waiting for government approval. Meanwhile, for those who are interested in trying various drugs, there's the work of John Chia that Sushi mentioned, and the studies and work from Dr. Martin Lerner, which I posted above.

 

[leokitten]

It may have changed but I don't think that some of the patients here who posted about getting Ritux infusions from OMI paid for more than the infusion costs, not the drug itself. Hopefully some of them will clarify this point.

I've read recent posts of people who went to OMI. They have to pay for everything and many of them spent something like $40k.

 

[leokitten]

If you read the tweets from today's conference and follow the other ongoing research, there is quite a lot of promising research some of which is already available as treatment = Dr. Chia's treatment of enteroviruses.

Sushi

I've written this elsewhere but I'm sorry I think prople need to be more critical of Dr. Chia

Dr Chia treatment of EV using IFN and getting improvement from a few patients is anecdotal and therefore useless, sorry he needs to put his money where his mouth is and do a proper randomized clinical trial with IFN to prove if it actually works. I totally hate when ME/CFS clinicians say they did this and that and it worked for people but they never care to spend the effort to prove it to the rest of the scientific community! You want to know why it's because he knows that it won't hold water in a real RCT.

If he actually found a cure or treatment giving remission in a subgroup of patients then wouldn't we all be running to him lining up for treatment? We aren't because people know in reality it doesn't work.

At least Fluge and Mella saw something so promising and had the courage to put their reputations on the line and put together a bigger and comprehensive set of RCTs to prove if their treatment will work and who it will work for.

That's so much better than Dr Chia's musings on EV. Interesting but useless.

 

[Nielk]

Rituximab is an FDA approved drug- just not for ME/CFS, yet.
No drug is FDA approved for ME/CFS, yet many patients try them like anti-virals, anti-seizures and more.
These other drugs have adverse effects as well yet severe patients are willing to take the risk for the potential benefits.

I took Rituximab for my RA a year ago. I had less side effects in it than many other treatments that U have tried for this disease.

Unfortunately it didn't help my RA or my ME. I am not sorry though that I have tried it.

It is interesting to note that Rituximab does not help every RA patient, although it is approved as a treatment. I have tried about 5 or 6 approved treatments for RA so far with no relief. My bloodwork, test results and symptoms all point to a definitive RA diagnosis.

What I am trying to say is that whether one is a responder on not to a specific treatment of for a disease is not a confirmation of diagnosis.

RA patients who are Responders or non responders to Rituximab or any other drug all suffer from the same disease, regardless of their response to any drug.

 

[Sushi]

If he actually found a cure or treatment giving remission in most patients then wouldn't we all be running to him lining up for treatment? We aren't because people know in reality it doesn't work.

One problem here is that, using stomach biopsies, I believe Dr. Chia has found enteroviruses in about 40% of those tested. (someone please correct me if I have this % wrong). We don't know if the patients he tested are representative of the overall ME/CFS population, but in cases of confirmed eneroviruses, he reports good success.

Sushi