Friday, April 15, 2016

Rituximab - A Promising Treatment for ME/CFS

Photo from Freeimages.com
I have been watching and reading the ground-breaking research on using a cancer drug, rituximab, for ME/CFS with great interest and wanted to provide a brief update here for those who haven't heard about it yet or who want more information (or, as always here, a simple explanation).

Rituximab is a drug that affects the immune system, used for patients with lymphoma, a form of blood cancer, and also for autoimmune conditions like Rheumatoid Arthritis (RA). There is now growing evidence that it might work for a majority of ME/CFS patients, either greatly improving their symptoms or even providing complete remission.

A simplified timeline of what's gone on so far:
  1. In 2004, two Norwegian doctors using rituximab for a group of lymphoma patients noticed that one patient - who also happened to have ME/CFS - was not only cured of his/her lymphoma but that all of his/her ME/CFS symptoms had disappeared as well.
  2. Excited by this unexpected occurrence, those same two Norwegian doctors conducted a small, 1-year study of 15 people with ME/CFS in 2011. A full two-thirds of the patients (10), experienced significant improvement on rituximab. Two of those 10 seemed to be completely recovered, even 3 years after their initial doses, and were back at work.
  3. In July 2015, results were published from a larger Norwegian study of rituximab in 29 ME/CFS patients, showing that once again, almost two-thirds of the patients (18) responded well and improved significantly, some achieving full remission. Eleven of the 18 who responded were still in remission three years after beginning the treatment, and some have not had symptoms for five years. This study included a variety of ME/CFS patients, ranging from moderate to severe (bedbound).
  4. A much larger study, of 150 ME/CFS patients, is now underway in Norway and includes a control group. Results are due to be published around 2017-18.
Can you believe those facts?? Two-thirds significantly better? Complete remission? These are words that many ME/CFS patients never thought they'd hear.

So, how does this miracle drug work?
Rituximab, a cancer drug, wipes out most of the body's B-cells, a kind of white blood cell that makes antibodies. In the ME/CFS trials, the doctors have generally seen a 4-6 month lag in response time after the first dose is administered, which is about the length of time it would take for existing antibodies to be cleared from the body. Patients showed signs of relapse at about 1 year - approximately the amount of time it would take for the body to make more B-cells and re-grow antibodies. The researchers have found in the series of studies that giving multiple doses of rituximab over a long period of time helps to increase the number of people who respond and decrease relapse.

Is there a down side? Definitely. Killing off all your B-cells is not without risks, and there can be serious side effects, just as there are with immunotherapy in cancer treatments. Some people feel sicker during that initial period. I don't know about you, but I would be very willing to put up with worse symptoms for a few months if it meant a 67% chance of remission. Rituximab is currently a very expensive drug.

Also, although two-thirds of patients responding is an amazing number in any treatment study, that still leaves one-third that does not. You could potentially pay a lot of money and suffer through that initial worsening, with no benefit...though the odds are in our favor so far. Future studies will try to figure out what separates the responders from the non-responders and what factors can help to predict who will benefit from rituximab.

I'm also not sure whether rituximab could be used in ME/CFS patients who have active infections, like my son who has Lyme disease plus two other tick infections. I would think that killing off all B-cells and clearing the body of antibodies wouldn't be a great idea with active infections present, but I'm no expert.

When will rituximab be widely available? So far, Norway has conducted all of the ME/CFS rituximab studies to date. UK advocates at Invest in ME have raised $600,000 for their own rituximab study of 30-40 people.

Rituximab is already FDA approved in the U.S., for lymphoma patients and also RA. It is sometimes used in the U.S. off-label (i.e. for purposes other than its official approval) for other autoimmune conditions, like MS, lupus, and others. I have no idea whether any ME/CFS specialist are yet prescribing it for patients here or whether they are waiting for the results from the largest Norwegian study. As for the cost, if it is eventually FDA-approved specifically for ME/CFS, then it should be covered by most health insurance; used off-label, as it could be now, insurance coverage will vary based on the insurer and the specific policy.

So, those are the basic facts - and exciting facts they are! Besides the links above to the two early Norwegian studies, you can read:

I plan to ask my ME/CFS doctor about rituximab on my next visit. I am interested to know whether she or any of her colleagues are using it yet here in the U.S. or whether there is any information yet to predict who will respond to it.

Do you know of any patients on rituximab or any doctors using it for ME/CFS yet?

What do you think of this exciting new possibility?

30 comments:

  1. My ME specialist nurse says she hopes it might be available on the NHS in the UK for ME in 5 years. I hope she's right!

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    1. That would be pretty quick, wouldn't it? Just based on what I've heard about your NHS. You certainly need more treatment options than just CBT and GET (which aren't actually treatments at all)!!

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    2. I think you're correct Sue. This has only been used in trials in Norway, which 'Hip' over on Phoenix Rising has suggested it showed more benefits than it's showing here (so far) because it may have been addressing a specific infection that was found to be prevelant in Norway at the time.

      Dr. David Bell said in a talk recently, that while he's excited about Rituximab, he thinks it will be at least another 20 years before it's approved (if it is) in the US.

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    3. Joe - That's an interesting theory I hadn't heard before. I wish OMI & others using it in the US would publish their results (even if they aren't controlled studies) so we could REALLY compare results in different places. Right now, I keep hearing negative things about use in the US but so far, it all seems to be hearsay and second-hand with nothing official written by the doctors using it and nothing concrete. All these rumors just tend to get blown out of proportion. Dr. Bell's remarks are interesting, too - he;s amazing & I have a lot of respect for him. My son and I saw him. Then again, that 20-year estimate is probably more a reflection of how slowly things go with the FDA than actual efficacy & safety!

      Thanks for the extra info!

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  2. Anonymous12:17 PM

    Several US-based doctors have been using rituximab (Rituxan)for (some) ME patients a few years now (beginning around 2012).
    The patent expired in 2015 so in theory it should be less expensive now.

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  3. As far as Lyme disease is concerned that might actually be his ME; you might find this interesting if you treat me with Rituximab when you have Lyme disease http://niceguidelines.blogspot.com/2015/09/me-made-worse-by-rituximab-you-might.html

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  4. I meant his ME might actually be Lyme disease as well

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    1. Oh, we KNOW he definitely does have Lyme, plus two other tick infections. They started several years after he got ME/CFS. My other son and I also got ME about the same time, so we know there is a genetic predisposition. Lyme and ME often co-exist - Lyme is one of many known triggering infections that cause ME to start in 10% of the patients who get the infection.

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  5. I've Just started taking "Low Dose Naltrexone" (LDN), for CFS/ME/FMA,But I Don't know IF LDN is gonna work,Or IF U can take LDN & rituximab At the Same Time,or after I've stopped taking LDN (assuming it dosn't work,or what... :) Tiredchris,Hull,England,16th April 2015.
    What doseage rituximab would I ask my gp for?
    Thanks

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    1. It is still very much experimental, Chris, so dosage isn't widely known yet and is probably not available through any GPs. This is all cutting-edge and brand new. I hope the LDN works well for you - it worked very well for my son and I. Good luck!

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  6. dianne12:03 AM

    sue . do you know what criteria was used to choose the ME patients for these trials ?

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    1. Just that they used a range of patients with different degrees of illness - one of those article links specifies how many were severe, moderate, etc. Also, when they tested the longer duration of treatment with more doses of the medication, they put some of the nonresponders from the first trial in that second one (some responded to the different dosing; some did not).

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  7. There was a small ME CFS study going on in usa in 2013 i think ... i knrw a woman who was in the study but she had no positive response from the drug. As far as i know the resukts of the study were never published so i have mo idea what happened.

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    1. Thanks for the info, Lee Lee - I hadn't heard about that.

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  8. Anonymous4:29 PM

    The Open Medicine Clinic is providing Rituxan for patients all over the world. I just finished my treatment with very little/no response. Very disappointing, but I felt I had to give it a try. It is very expensive, but there is a pretty good program to help with medication cost if your income is at a certain level and you can prove your insurance won't cover it. Even with the medicine free, the visit is $1500 to $2000 each (x6) plus hundreds of dollars of blood tests. I know there are certain infections they test for before you can go through it, I don't know if Lyme is one of them.

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    1. Marcia6:12 PM

      It's worth noting that Rituxan is probably the reason Whitney Dafoe's condition worsened so dramatically after he started Rituxan. It's not absolutely certain of course, but even Whitney himself mentioned it in several posts.

      People are so desperate for a 'miracle drug' (which this definitely is not), that they attacked the writer of the article, dismissing Whitney's own posts on the matter:

      https://www.sciencebasedmedicine.org/chronic-fatigue-syndrome-rituximab-revisited/

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    2. Thanks for the info on what OMI is doing with Rituxan - I appreciate it! So sorry to hear it didn't work for you. I'm wondering if OMI is using the longer treatment protocol that the Norwegians developed in their latest study.

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  9. Anonymous7:27 PM

    I thought they all had their ME return once Rituximab was stopped.

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    1. No! That's the exciting part - if you re-read my post above, you'll see in #3 that many of the patients are still symptom-free 5 years after their initial treatment! It's a matter of "re-setting" the immune system.

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  10. I respond very well to Ampligen, but the FDA can always pull the rug out from us patients, so I'm always looking for Plan B.

    When off Ampligen, I had HHV-6 and CMV in my spinal fluid. (Other viruses in my blood.) So I have wondered how rituximab would work with those of us who have immune defects and activated viruses. I guess i'll have to wait a while to find out.

    However - just because Rituximab is not approved for use for ME or CFS by the FDA does not mean you can't get it - that's what "off-label" means - if it is approved for one condition, you can get it off-label for others. But ... you have to pay cash. As I do for Ampligen.

    At any rate, following the rules by which the AIDS community came together many years ago - if it works for some of us, then all of us must campaign for it to be available. I'm just hoping we get more information soon about which biomarkers suggest it will be successful.

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    1. That's a very good point, Mary, especially for this complex disease: we need to support research & availability of any and all treatments. I often say that nothing I've tried (and I've tried a lot of things!) has helped a lot but many treatments have helped a little, and those little bits do add up. We need all the treatments we can get!

      Sue

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  11. Hey Sue!

    I've just managed to start reading your blog and as an ME/CFS suffer I've found reading this so useful! I've just started to blog about my ME/CFS, the link as at the end of this comment!

    Keep up the fight!

    Love, Cat xxx

    http://catsrecoveryjourney.blogspot.co.uk/

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  12. In the late 80's, early 90's I was on 6-mercapopurine for Crohn's Disease and felt better than I had in years even returning to work but I stopped the medication after surgery to remove my colon and the effect faded over 2 years. The trouble is finding a doc who'll let me try it again.

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    1. I'm not familiar with that medication, but I'm sorry to hear you are having trouble getting access to it again. Have you tried low-dose naltrexone yet? It's a super low risk med (used in tiny doses) that works well for most immune disorders - the studies using it for Crohn's have been amazing! Good luck.

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  13. I've been on LDN since 1st April 2016 & I Han't felt Any different,whatsoever... :(
    Where,in the UK,can U get rituximab in the correct dosage for CFS?

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    1. Sorry to hear that LDN hasn't helped you. What dose did you try? Did you feel any worse or just no different?

      As for Rituximab, it is not generally available at this time for ME/CFS - it is still in the experimental stages, as I describe in more detail in this post. The UK is hoping to start its own Rituximab study soon, though. That is being done through Invest in ME so you might contact them to see if you can get into the study.

      Be cautious, though, because Rituximab has some major risks, as I mentioned in this post.That's why most doctors are waiting for more extensive research, to help identify who will respond to it and who it will harm.

      In the meantime, while we wait for that research, there are plenty of other, well-tested treatments that might help you without the big risks. Here is a summary of what has helped my son and I the most:

      http://livewithcfs.blogspot.com/2015/08/effective-treatments-for-mecfs.html

      Sue

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  14. I tried a build-up dose to 4.5ml's,daily,since 1st April 2016.I pay for it,privately,through "Clinic 158" in Scotland. NO good effects,NO bad effects... :(

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  15. IF I can get it via "InvestinME",will I have to pay for it? I just live on state sickness benefits...

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    1. You'll have to ask them that. I don't know how their new study will work - I don't even live in the UK! If you are interested in their study, contact them & ask about it. Just remember this is an experimental treatment that may have significant risks so be sure to ask about those, too. Good luck!

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