Has anyone tried rituxin?

Discussion in 'Fibromyalgia Main Forum' started by ulala, Jul 7, 2009.

  1. ulala

    ulala New Member

    One of my doctors offered me either rituxin or IVIG last September. I decided to do the IVIG and it has helped me but not to the extent that I would like. I was rear ended by a car this past March and it seems to have exacerbated all my symptoms and wiped out a lot of the progress that I made with the IVIG. I am thinking about trying the rituxin. The potential side effects are very scary, but it also sounds like the potential upside is great. Any thoughts?
  2. SpecialK82

    SpecialK82 New Member


    Would your doc prescribe rituxin for CFS? I didn't realize that they were able to prescribe it yet - beyond research studies for CFS. If it prescribed off-label do you know if insurance will cover it? I would be interested in trying it as well, but I would need to do alot more reading on it - like you say, the side effects are very scary and I guess it should be looked at as a last resort.

    Can you tell me how the IVIG helped you exactly? How long you had to take it, etc. Did you have any side effects from it? Maybe you should try the IVIG again if helped the first time and then consider rituxin if it doesn't work?

    May I ask what kind of doc you are going to, is it alt med? I can't find any docs in my area that know CFS well enough to come up with those types of options.

    I will be watching this thread to see if someone on here has tried rituxin.


  3. ulala

    ulala New Member

    My doctor would prescribe it because I had a blood test that showed elevated B-cells. I think everybody here should have their B cells tested. From what I understand B-cells are white blood cells that are supposed to attack invaders. Something can go wrong and these white blood cells start forming auto antibodies and the body starts attacking itself, also called “friendly fire.” Because I have the elevated B cells my insurance will pay for it.

    I’ve read about a lot of people getting their lives back after rituxin. The IVIG made me feel better in general, more energy, but still not back to normal. I still get the IVIG once a month and hope to continue it as long as I can. My doctor is a rheumatologist who treats very aggressively and seems to be up on the latest treatments. He told me about the rituxin last September but I didn’t understand anything about B cells then. I have an appointment with him this Monday. It will be interesting to hear what he has to say when I tell him that I want to try the rituxin.

    Where do you live?
  4. pam_d

    pam_d New Member

    ...would be my advice. I am a two-time acute leukemia patient, never used rituxin, but I have several friends with lymphomas who are being treated with it. For them it's a no-brainer (they can possibly extend their lives with rituxin) but it does have major side effects, so just know what you're getting into. Also be sure insurance covers it, not just what your doctor says. I wouldn't think very many insurance companies cover it at this point---botox has been recommended for years now for migraines, and few companies cover that. So I'm just saying, do the research before committing to something hugely expensive.

    As a patient with aggressive leukemia & a bone marrow transplant, I've taken the strongest chemo out there (no other option but certain death) so I know you do what you have to to survive, I'd just suggest knowing all you can upfront.

    Hope this indeed offers a cure finally, and insurance companies recognize the value in paying for it. Good luck!

  5. ulala

    ulala New Member

    he mentioned rituxan because of the elevated CD19 B cells. I’ve also been diagnosed with sarcoidosis, which is an inflammatory disease. I’ve had other positive tests, i.e. C-Anca and ANA. He just said that this treatment could help the elevated B cells. I didn’t pay that much attention at that time because I really didn’t understand what he was talking about. When he mentioned the risks and that IVIG may also help then I just focused that. I’ll see him this Monday and ask him more questions about it

    I think that most CFS patients should see have a good work-up from rheumatologist because there are a lot of inflammatory markers that can help diagnose what’s really going on with the patient. Some of the things he tested were HLA-27, te CD white blood cells, CRP, Immunoglobulins - IgG, IgA, IgM, IgE, C3, C4, C-ANCA, P-ANCA, ACE, ANA.Allergy- IgE, Cardiolipin and IgG Subclasses 1,2,3 and 4. I guess from these results he made his decision

    I think that low dose methotrexate has also made me feel better in the past. even though I resisted taking it.

    Pam-thank you for your insights. Did the bone marrow transplant help you? I've heard that can be a very painful procedure. The chemo must have been very difficult, too. I hope that you are doing well from all that you have been through.

    I have Medicare and it seems that the doctors won't approve any procedure unless they know that it's covered. I will most definitely research all I can about the side effects before I move forward with the rituxan. From what I"ve read some people have had no problems with it and others have had bad reactions, especially with the first infusion. The first infusion seems to be the most important as far as bad reactions happening. I also read that people that are allergic to mice should be more careful because this drug could possibly have some mouse protein in it since it's made partially from mouse protein. I think I may have had an allergy test for mouse or rat at some time, (gross) I'll have to search for that test.

    Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series
    Oystein Fluge and Olav Mella

    BMC Neurology 2009, 9:28doi:10.1186/1471-2377-9-28

    Published: 1 July 2009

    Abstract (provisional)
    Background Chronic fatigue syndrome (CFS) is a disease of unknown aetiology. A patient with CFS had unexpected, marked recovery of CFS symptoms lasting for five months during and after cytotoxic chemotherapy for Hodgkin's disease. We reasoned that the transient CFS recovery was related to methotrexate treatment, which induces immunomodulation in part through B-cell depletion. Methods In a case series, this patient and two additional CFS patients were B-cell depleted by infusion of the monoclonal anti-CD20 antibody rituximab

    I copied this from a post Reviving the Marionettes- it mentions rituxan

    Because new research is constantly coming out, new medications are approved and sometimes old ones are withdrawn from the market, this page will include any updates and possible corrections to Reviving the Broken Marionette. If you have noticed an error in the book or are aware of any new data that has come out since its publication, please contact the author at book@brokenmarionettebook.com. Please list any sources for your information. You will be credited for the information, but only if you specifically request to.

    6th July 2009
    Some new CFS/ME research of value has been published. In February this page reported that a new U.S. clinical trial is trying rituximab (Rituxan) for CFS/ME. Now a new case series published in the journal BMC Neurology describes three patients who experienced improvement (from mild to major) in their CFS/ME symptoms from this immunosuppressant. Two of the three were also tried on methotrexate, an older chemotherapy drug used as a less selective immunosuppressant and one of the two benefited from this treatment. While these findings sound very promising, it should be kept in mind that immunostimulants are generally a much safer treatment for CFS/ME (as well as autoimmune diseases) and they too can have excellent efficacy, without the need to worry about cancer, opportunistic infections or other serious complications of immunosuppressants.

    Aa Belgian research group (including Kenny Meirleir) studied the intestinal flora of 108 CFS/ME patients and compared it to 155 healthy controls. A significant increase in the number of some lactic acid producing bacteria (Enterococci and Streptococci) was found in the patients compared to the controls. The abstract from the journal In Vivo notes that "Given the fact that this might explain not only neurocognitive dysfunction in CFS patients but also mitochondrial dysfunction, these findings may have important clinical implications." It might give more weight to the use of certain antibiotics like rifaximin (pp. 93-94) to treat dysbiosis of the gut in CFS/ME. The implications of this study on probiotic treatment are unknown. Previous studies on the gut flora of CFS/ME patients have found a deficiency of Bifidobacteria.

    Another study, from the journal Neuropsychiatric Disease and Treatment, posits that the fatigue and other neuropsychiatric symptoms in CFS/ME and other neurological diseases may stem from autoimmunity affecting some important neuropeptides, causing "leakiness" of the blood-brain barrier. They suggest the PDE4 inhibitor drug rolipram as a potential treatment, but rolipram is not currently on the market anywhere. Other PDE4 inhibitors like pentoxifylline (pp. 181-182) and ibudilast (p. 277), could be similarly useful. The problem with PDE4 inhibitors, which have been studied in e.g. depression, multiple sclerosis and pulmonary conditions, is that they generally cause too many side effects and this is why they usually end up being discontinued before marketing approval, ibudilast being a notable exception. The article also lists the antidepressant imipramine (p. 115) as a potentially useful treatment of this autoimmune blood-brain barrier disturbance.

    27th May 2009
    Another intriguing new fibromyalgia study is to be published in the journal Clinical Rheumatology. It is about tegaserod (Zelnorm), a drug used in the treatment of irritable bowel syndrome (IBS). The study found that patients with both fibromyalgia and IBS experienced a significant decrease in fibromyalgia symptoms, such as pain and tender point count, when taking tegaserod for their IBS. Tegaserod is a (partial) agonist of the 5-HT4 serotonin receptor. Previously many studies have found antagonists of the 5-HT3 serotonin receptor (granisetron, ondansetron and tropisetron, pp. 259-260) which are primarily used as antiemetics (for nausea caused by chemotherapy) to be helpful in both IBS and fibromyalgia, but this was the first study evaluating a drug acting on the 5-HT4 receptor.

    Unfortunately the 5-HT3 antagonists are extremely expensive while tegaserod has been withdrawn from the market in the U.S. (and most other markets?) due to concerns over possibly increased cardiovascular risk. Several other 5-HT4 agonist drugs exist besides tegaserod, but most of them have either been withdrawn as well, are only in clinical trials or have many other pharmacological properties (like the antiemetic metoclopramide). Cisapride (Prepulsid) might be a viable option, but it too is only available in Australia and some European, Asian and South American countries.

    7th May 2009
    Interesting new research on both CFS/ME and fibromyalgia fronts. In a new study published in the journal In Vivo parvovirus B19 DNA was detected from the gastrointestinal mucosa of 40% of CFS/ME patients but only 15% of controls. This isn't the first study to implicate the role of parvovirus B19 in CFS/ME, but still the results are somewhat surprising. Unfortunately there are no specific antiviral treatments against parvovirus B19, but intravenous immunoglobulin (Reviving the Broken Marionette, pp. 207-208) has been reported to be curative in some cases of CFS/ME caused by parvovirus B19.

    The results of the first study of low dose naltrexone (LDN, pp. 214-215) for fibromyalgia were finally released. Maija Haavisto considers LDN the best treatment for both fibromyalgia and CFS/ME. The small placebo-controlled study, to be published in the journal Pain Medicine, found that LDN produced very significant improvement in pain and fatigue compared with placebo. The researchers at Standford university (which curiously also happens to be the same place where the valganciclovir trials are taking place) are currently conducting a study of LDN for juvenile fibromyalgia. This is very good news, as there are very few studies of treating fibromyalgia in children.

    Another interesting new study published in the Journal of Pain has found that in low doses the beta blocker propranolol (Inderal, p. 176), commonly prescribed for palpitations, anxiety and migraine prevention, can significantly reduce pain from both fibromyalgia and temporomandibular joint disorder. Because propranolol is a very common drug, fibro/TMD patients should not have much problem getting a prescription for it, if they want to try it out themselves (the research is preliminary, but low doses of propranolol are very unlikely to cause major side effects).

    10th March 2009
    More new research about IV treatments. A study to be published in the journal Clinical Rheumatology found intravenous lidocaine (Reviving the Broken Marionette pp. 67-68) effective for fibromyalgia and the efficacy was maintained 30 days after the last infusion (most likely much longer than that, but they only tested at 30 days). This was, however, an open-label study (not placebo-controlled), but lidocaine is difficult to administer blindly anyway, even as an IV infusion. Hopefully this study will lead to bigger future studies and to increased use of IV lidocaine as a treatment for fibromyalgia.

    4th March 2009
    A new placebo-controlled study about the intravenous nutrient therapy Myers' cocktail (p. 249) in the treatment of fibromyalgia has been published. The treatment resulted in marked improvement in all parameters, but because the study was fairly small and the placebo group also noted substantial improvement, the treatment effect was not considered statistically significant (even though the treatment resulted in more improvement than placebo). It should be noted that the "placebo" was an intravenous infusion of Ringer's lactate, which may not be a true placebo, as intravenous saline infusions (pp. 250-251) are helpful for many patients with CFS/ME. CFS/ME specialist David Bell has even voiced an opinion that blood volume expansion may explain the efficacy of many therapies that are administered as IV infusions.

    22nd February 2009
    The pharmaceutical company UCB has announced the results of two studies relevant to people with CFS/ME and fibromyalgia. Unfortunately this time the results were disappointing. The results of neither the phase IIa study of lacosamide for migraine prophylaxis (prevention) nor phase IIa study of rotigotine for fibromyalgia reached statistical significance for their primary endpoints. This does not mean that these medications are now deemed completely ineffective for these purposes, but they were less effective than thought and there will probably be no phase III studies. Lacosamide (Vimpat) is an anticonvulsant recently approved in the U.S. which has been in successful clinical trials for fibromyalgia. Rotigotine (Neupro, p. 164) is a dopaminergic drug which is only available as a patch.

    On the CFS/ME front, the final decision date for the FDA approval of Ampligen (pp. 222-223) was postponed by three months, from February 25th to May 25th. By this date we should find out whether the FDA will approve Ampligen as the first drug indicated for the treatment of CFS/ME.

    An interesting U.S. clinical trial will be trying the monoclonal antibody rituximab (Rituxan) as a treatment of CFS/ME. It is used in illnesses characterized by excess of B cells, including some autoimmune diseases, lymphoma and leukemia. It is an immunosuppressant and patients with evidence of viral infection are not allowed in the study, which is rather peculiar when the illness studied is generally considered to be a chronic viral infection, as is the case of CFS/ME.

    16th January 2009
    Here's the news I've been expecting for a while: milnacipran was approved by the FDA for the treatment of fibromyalgia, to be sold with the brand name Savella. This is now the third drug approved for the treatment of FM in the U.S., and the first one to be approved without a previous indication (milnacipran is an SNRI antidepressant like duloxetine (Cymbalta) and it has been used to treat depression in Europe, but has not been approved as an antidepressant in the U.S.) Milnacipran may be better tolerated than Cymbalta, and at least here in Europe it is also very inexpensive. You can read more about it in Reviving the Broken Marionette (pages 124-125).

    The next drug approved for fibromyalgia will probably be sodium oxybate (Xyrem, p. 32). Another new study recently vouched for its efficacy and tolerability in this use.

    30th December 2008
    A big new study about the SNRI antidepressant milnacipran in fibromyalgia (Ixel, pages 124-125) involving over 1,000 patients has been published in the journal Clinical Therapeutics. Milnacipran was found to help pain significantly already after one week. It also helped fatigue and functionality. About 20% of people taking milnacipran and 10% of placebo group discontinued the study prematurely due to side effects. This study makes it likely that milnacipran will soon be approved by the FDA for fibromyalgia (it is not yet available in the U.S., but is used for depression in many European countries).

    23rd November 2008
    An interesting new analgesic tapentadol has been approved by the FDA. Tapentadol is an opioid painkiller somewhat similar to tramadol (page 58), but instead of increasing the reuptake of serotonine and norepinephrine (noradrenaline), it only increases the reuptake of norepinephrine. This may make it better tolerated than tramadol for some people. It should be a good painkiller for those with fibromyalgia, and probably for CFS/ME as well.

    In other news levetiracetam (Keppra, page 82) should now (or soon) be available as a generic drug. This is very good news, as levetiracetam may be the best tolerated anticonvulsant, but in large doses it has tended to get quite expensive. Also granisetron (page 259-260) is now available as a transdermal patch with the brand name Sancuso.

    30th October 2008
    FDA has approved lacosamide (Vimpat) for the treatment of partial-onset seizures, a type of epilepsy. This is very good news for patients with fibromyalgia, as well, as lacosamide has been found to be effective in fibromyalgia (see the entry for 25th June) and it could be prescribed for FM off-label. It could also be helpful for people with CFS/ME. Lacosamide was approved for the EU market a few weeks ago.

    Lacosamide has a novel mode of action, meaning that no other anticonvulsant or other drug works by the same mechanism. Thus it could help those who haven't benefited from other treatments - even though it is fairly unlikely that someone would not benefit from any other treatments but lacosamide, considering there are over 250 medications that can be used to treat fibromyalgia and CFS/ME. On the other hand, as many anticonvulsants are widely used in the treatment of chronic pain, doctors may be more likely to prescribe lacosamide for fibromyalgia patients, compared to more "experimental" treatments.

    28th October 2008
    It has been quiet on the research front, hence the lack of updates. There is one recent case report of interest, published in the Journal of Musculoskeletal Pain. A patient who had both fibromyalgia and ADHD and whose pain had not responded to several therapies responded "dramatically" to atomoxetine (Strattera), noting 60% reduction in fibromyalgia pain and marked improvement of her functional status. Atomoxetine is featured on page 126 of Reviving the Broken Marionette.

    Many important CFS/ME and fibromyalgia drugs are still waiting approval from FDA and/or EMEA, the European Medicines Agency. EMEA recently decided to recommend European approval of the sleep aid eszopiclone, which is to be sold as Lunivia in Europe (see page 26 in the book). However, EMEA also rejected to extend the indication of duloxetine (Cymbalta) for the treatment of fibromyalgia, which is peculiar, as the FDA has already approved duloxetine for this indication. Obviously duloxetine can still be prescribed for fibromyalgia (and CFS/ME) off-label in Europe.

    19th August 2008
    A new paper published in the journal Medical Hypotheses suggests iodine deficiency as a possible cause of subclinical hypothyroidism which may underlie fibromyalgia and other illnesses. There is already evidence that thyroid problems may be behind a subset of fibromyalgia cases (see pages 198-200 in Reviving the Broken Marionette) and iodine deficiency might be a causative factor. Please note that this is not a scientific study, only a paper describing the hypothesis. You should discuss any possible iodine supplementation with your doctor.

    In other, slightly more worrisome news, a recent study suggests some sleeping pills, particularly the "Z drugs" and ramelteon, as possible carcinogens (the possible carcinogenicity of zopiclone is actually discussed in the book on page 26). It is quite peculiar if ramelteon turns out to be carcinogenic, as it affects the melatonin receptors and there is a wealth of evidence that melatonin has anticancer properties. Note that there is no clear evidence that these drugs cause cancer, but if you are worried you may want to bring it up with your physician. Melatonin remains a safe choice, but like all drugs it is not for everyone. Reviving the Broken Marionette also reviews dozens of other drugs than can help insomnia and other sleep disorders.

    25th June 2008
    There are good news for fibromites again (it looks like we are on a roll here!). A phase IIa trial found the novel anticonvulsant lacosamide effective for fibromyalgia. The drug was also found "very well tolerated." Lacosamide is not included in Reviving the Broken Marionette, because it has not yet been approved anywhere. FDA and the European Medicines Agency are currently reviewing the company's new drug application and the drug could be approved for use in partial-onset seizures (a type of epilepsy) and diabetic neuropathy in the near future, with the trade name Vimpat.

    Before lacosamide can be officially approved for fibromyalgia it needs to go through more trials and it would take until the end of next year at the earliest before it could receive approval for this indication. Of course, even if it is not approved for fibromyalgia, doctors can still prescribe it off-label for fibromyalgia (and CFS/ME) once it is approved for use in another condition. If/when lacosamide is approved, more information about it will be posted on this site.

    18th June 2008
    Duloxetine (Cymbalta), a SNRI antidepressant made by Eli Lilly, has been approved as a fibromyalgia treatment by the FDA, making it the second drug approved for this purpose after pregabalin (Lyrica) - just like I predicted in my book (Chapter 5). This is good news for people with FM, but keep in mind that it does not mean that duloxetine is actually a better drug for fibromyalgia than e.g. the other SNRI antidepressants - venlafaxine (Effexor) and milnacipran (Ixel). It only means that the manufacturer wanted to invest in the appropriate studies to gain FDA approval for this use, which isn't cheap at all.

    It remains to see whether the third officially approved drug will be sodium oxybate (Xyrem), milnacipran (Ixel), flupirtine (Effirma) or something else. The FDA is still considering Hemispherx Biopharma's NDA for Ampligen as the first official CFS/ME treatment.

    15th June 2008
    An interesting new study will be published in the July issue of European Journal of Internal Medicine titled "Efficacy of Raloxifen in treatment of fibromyalgia in menopausal women." In the study ralofixene was found superior to placebo. It improved both pain and fatigue. Raloxifene is a selective estrogen receptor modulator (SERM) and is, of course, featured in the book (Chapter 10), but this is the first study done of its use for fibromyalgia (no studies about CFS/ME have been done).

    Content by Maija Haavisto. Last modified: 6th July 2009.

    Thanks again and best wishes!

    [This Message was Edited on 07/11/2009]
  6. SpecialK82

    SpecialK82 New Member

    I live in Cincinnati, OH, do you happen to live anywhere close by? I would love to see your doctor.

    I have not heard of the B-cell depletion theory until very recently, and to my knowledge have never had my B cells tested. I am curious now if they are elevated. I wonder how I can get the test done. Is this something that your rheumatologist was just testing in a standard workup? Or did you have other problems and he tested your level?

    I have heard some stories of bone marrow transplants but I haven't heard alot of success with this route. I will have to do more reading in this area. I wonder if just doing the B-cells is a better treatment? Obviously less risky and traumatic...

    I am excited to see your results if you start on rituxin.

  7. ulala

    ulala New Member

    I live in Los Angeles. Do you live by the Cleveland Clinic? Can you find out if there are any good rheumatologists there? I was there visiting a relative in 2005 and saw a doctor there for FM. What a waste of time.

    I checked clinical trials in Ohio and rituxan and came up with this:
    http://clinicaltrials.gov/ct2/results?term=rituxan+AND+ohio. Maybe you can look at these and see if there are any of these doctors that are in your area and make an appointment to see them.

    Yes, my doctor (a rheumatologist) tested my B-cells during my first visit with him. I saw him again yesterday and he did a follow-up blood test for B-cells. He said that the insurance companies are getting stricter about paying for this test. He said they’ll pay for it with a diagnosis of anemia.

    I’ve read a little about bone marrow transplants but don’t really remember too much aobut what I read. I would think that it would be difficult to find a match and also a very painful procedure.

    My doctor said that the test results will take 2-3 days. I think that the results will be the deciding factor if I get the rituxan. I’ll let you know what happens.

    Let me know if you get your B cells tested.

    Best wishes
    [This Message was Edited on 07/14/2009]
  8. pam_d

    pam_d New Member

    I have had an unrelated donor bone marrow transplant. It is no picnic. It is also a procedure that can cost upwards of $500,000. Even with a diagnosis of Acute Leukemia, which I had, there are costs insurance doesn't pay for. With a CFS dx, I doubt anything would be covered. So one would have to be independently wealthy to have this procedure. I am still recovering from the financial costs and will be for years, if I live that long. My 5-year survival rate stands at about 40%.

    Know that the mortality rate for just surviving the procedure and recovery period is about 30-40% depending on age. I know many patients personally who survived the initial procedure, then died of complications afterward. Or have horrible quality of life afterward, due to GVHD, Graft vs. Host disease, which can be life-threatening. In our cases, the only alternative was certain death, so we really had no option.

    Maybe in the future, when transplant costs and complications might be more manageable, a BMT would be more realistic for CFS patients. I personally would only have one if I was dying...which I would have if not for the procedure.

    Rituxin, even with its serious side effects, seems like a much less damaging thing to try first.

  9. ulala

    ulala New Member

    I’m glad that you were able to have the procedure and that you are OK, but what a nightmare having to go through that and to have to pay so much money on top of what you went through. Even the aftermath sounds terribly daunting. How long has it been since you had this procedure?

    I guess rituxan wouldn’t have worked fo you or you would have had that instead of the BMT. My thoughts and prayers are with you for a full recovery. Thank you for sharing this information with us. Again, Godspeed for a full recovery.

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