Lymphoma Drug, Rituximab, Highly Effective in Treating Relapsing MS, Study from Sweden Reports

Lymphoma Drug, Rituximab, Highly Effective in Treating Relapsing MS, Study from Sweden Reports

Mabthera (rituximab), a widely approved drug for treating lymphoma and/or rheumatoid arthritis, is highly effective in treating multiple sclerosis (MS), researchers reported in an observational study in Sweden, where Mabthera is increasingly being used outside of its approved indications to treat relapsing-remitting MS patients. The study, published in the journal Annals of Neurology, is titled “Rituximab versus Fingolimod after Natalizumab in Multiple Sclerosis Patients.

Researchers also found the drug more effective than an approved MS drug, fingolimod, at reducing the risk of disease flares and with lesser side effects in patients moving off Tysabri (natalizumab). Tysabri is a highly powerful and effective MS drug, but one associated with an enhanced risk of contracting an opportunistic and potentially fatal viral brain infection through long-term use.

Rituximab is a monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B-cells, and is used to treat diseases characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejections, and autoimmune disorders.

Fingolimod (Gilenya) is an immunomodulating drug, mostly used for treating MS, and known to reduce the rate of relapses in relapsing-remitting MS (RRMS) by approximately one-half over a two-year period.

The study was conducted in Sweden at the MS clinics at Karolinska University Hospital, Sahlgrenska University Hospital, and Umeå University Hospital. Researchers compared outcomes for all 256 RRMS patients who had switched from natalizumab to either fingolimod or rituximab.

Results revealed that, within 1.5 years of ending natalizumab treatment, 1.8 percent (rituximab) and 17.6 percent percent (fingolimod) of the patients had experienced a clinical relapse. In terms of safety, the occurrence of adverse events was lower in the rituximab group (5.3 percent) than in the fingolimod group (21.1 percent). Likewise, treatment discontinuation was reported in 1.8 percent of those taking rituximab and 28.2 percent of those on fingolimod.

Contrast-enhancing lesions, examined using magnetic resonance imaging, were also found in only 1.4 percent of rituximab-treated patients, versus 24.2 percent of those given fingolimod.

“We found that patients treated with Mabthera ran a much lower risk of their MS flaring up after the change of drugs than those treated with Gilenya,” Fredrik Piehl, professor at Karolinska Institutet’s Department of Clinical Neuroscience, a consultant at Karolinska University Hospital’s neurology clinic, and the study’s principal investigator, said in a news release. “Those who changed to Mabthera also had a lower risk of developing an adverse reaction to the new drug.”

Mabthera has not been approved for the treatment of MS, in Sweden or elsewhere. But a growing number of patients in that country are being prescribed the drug as clinicians have found it effective.

“The results we’ve seen in this study provide strong support for the genuine efficacy of Mabthera in the treatment of high-inflammatory MS and for it being a valuable alternative to approved MS drugs for this category of patients,” Professor Piehl concluded. “It would also bring considerable savings to the healthcare services as it is much cheaper than the regular MS drugs.”

36 comments

  1. Claudia Chamberlain says:

    I currently sit at my computer in a hotel in India. I live in San Francisco. My doctor wanted me to start Rituxin two years ago, but as it was not approved for MS in the US, my insurance company would not pay for it. I appealed for two years and ultimately appealed directly to Genentech who said I was too wealthy too qualify for one of their programs. (I am not wealthy, I live in exorbitantly expensive San Francisco!). I would have to be homeless to qualify for their program and live in SF. Hence India. Genentech told me that I could purchase Rituximab for $15,000.00, not including the infusion itself. I came to India to a beautiful private hospital and received Rituxin (complete with La Roche Genentech’s label-for India only) and am receiving my second infusion tomorrow for a total of $3,500.00. My flight was $999, and my very nice hotel near the hospital is $1,500.00 for a total of $6,000.00. The MS Gravy Train is ending for you Genentech! Thank you for writing this article!

    • M C H says:

      Can you share the name of the hospital? I, too, live in SF and take Rituximab and am always afraid I won’t be able to afford my next dose.

      Thanks!

      • Claudia Chamberlain says:

        Yes, I arranged for the trip online with Indian Med Trip [email protected] who put me in contact and arranged for my appointments with the neurologist at Fortis Memorial Research Institute in Gurgaon (just South of New Delhi). Everything went smoothly and the hospital is beautiful. I stayed at a hotel a few blocks away called the Palms Town and Country Club which I would also recommend. Good luck!

    • A. Isbell says:

      Bless your soul!!! My doctor in NY has just suggested that I make this switch. I go to a research hospital so that may be the difference. I am nervous but the more I read the more relaxed I get about this possible change. Currently on Tysabri.

      • Christine R says:

        CHANGE – CHANGE – CHANGE – Tysabri sneaks up on you and I was days from DEATH – resulted in a 30 day hospital stay ONE DAY in front of my next scheduled infusion. God works in mighty ways – I would have walked into the clinic and had a DROP of that ^&^&*^&*^ and been in LIVER DEATH and flatliner. I am anxious to hear of your choice and if you followed thru to a safer option.

    • Peter DeLuca says:

      My Name is Peter DeLuca and I Live in Tucson Arizona. I am so glad to read you are being treated with Rituxan no matter what the cost or method. Rituxan changed my life. I was on Copaxon for about 6-7 years with no sign of it doing anything. I had tried every natural type of treatment and even went to a healer in Brazil. I gave up hiking, which had been my passion, and was using a cane whenever traveling because of long walks through airports or if I needed to walk anywhere longer than a couple of minutes with out rest. After 3 years on Rituxan and now 6 years since my last treatment I am able to hike 5-7 mile on our steepest trails in the mountains. I do use hiking poles and am not as fast as I use to be but I am so thankful for this drug and would encourage anyone to find a way to get treated with it because for me it was a life changer.

      All the best on your treatments!!

      • Lisa Critch says:

        Hi Peter. Thank you for giving info. I currently take Tecfidera and will be seeing my Neuro at the end of the month. Tecfidera was a great change from Extavia. I no longer have the mind fog. I guess I am selfish because I want to go on long walks again. I was an active person and I would love that again. I have become almost hermit like now. I have
        Researched so many drugs that I need to concentrate on each one. I have been looking at Rituximab and I would love to have good news about this treatment so I can have a sensible conversation with my Neuro. My question is: would you make this change of meds again?
        I look at the stairs as a possible reason for a hip relacement or wrost surgery. I am 51. Diagnosed in 2001. DMT started in 2010. Got through my relapses with Prednisone. Can you let me know how you see this? Thank you, Lisa.

    • Christine R. says:

      How was your infusion AFTER EFFECTS-? I had alot of FLARES around GI tube-my recently injured foot injured(due to wheelchair)swelled-had many problems with any injured area showing pronounced diffuculty in healing-setting me back-and more what you would call-MS fatigue-& MS FOGGY brain. Did you experience any of those? I am set for second infusion-am wondering to do it again? Did you do it ALL in one day? Do you have PPMS or SPMS – I was classified “third-degree” with GI-caths- wheels etc. but try hard not to wear the labels-stay VERY active in the mind. Please let me know how your doing POST infusion – also from the Bay Area..MS friend and fighting the crime together- Christine

  2. Regina Alice Schroeder says:

    I am frustrated with this as well. But consider, is this somewhat akin to foreign aid where the rich countries are subsidizing the drug’s availability to poorer countries?There may be some greater good rationale. I get rituximab for MS through Medicare because I qualify for disability. My friend, who continues to work full time very as a nurse supervisor, cannot get the drug approved by her private insurance company. Working with Genentech to try to get her another dose of the drug before Ocrelizumab is approved the end of 2016.

    • Claudia Chamberlain says:

      My thoughts are that it is not because Genentech/LaRoche is being altruistic that they charge much less in India. It is because India is a hugely populous country and there are at least two generic drug companies in India that make Rituximab for much, much less. Remember that Rituxin is also prescribed for lymphoma as well as other autoimmune diseases. If Genentech didn’t lower their price they wouldn’t sell any of their product in India.

    • Karen Denes says:

      My new Neurologist wants me to get Rituximab to treat my MS also. I also am on disability and have Medicare. Did you have to appeal to get covered drug coverage for this off-label usage? Any information would be useful.
      Thank you,
      Karen

  3. Jeanine Shahin says:

    I heard the from my daughter’s neurologist about rituximab and insurance companies not paying because of its use off label. This very unfortunate since it’s patent expired and is less expensive with a long record of use. Ocrelizumab will be very expensive. The insurerers should wake up. I would be more comfortable with rituximab because it has been around for a long time. There is no financial incentive to pursue MS indication. Big Pharma at work again compromising people’s lives for Their own personal gain. Why doesn’t the MS society conduct a clinical trial?

  4. Jeffrey Lagomacini says:

    My MS Specialist from the University of Miami (Florida) has had me on Rituxamib infusion four times per year (twice every six months) for my Primary Progressive MS (PPMS).
    The study found in this article refers to ‘Relapsing Remitting MS’.

    QUESTION:
    Has Sweden conducted a similar study for PPMS? I am curious to read their results.
    Thank you!

    • Linda Arena says:

      Hi
      you say you get treatments from Florida?? Is it covered by insurance?? My son has PMS and we would like to get him on Rituxan. Is there a name of a person I could contact to guide me.
      Thank you so much

      • Rhea P says:

        Hi I get treated for rrms and my insurance is covering Rituxin I just pay $85.00 for the medicine. I live in Pittsburgh. PA

  5. Jeanine Shahin says:

    Another CD20 blocker ocrelizumab is pending approval for RRMS and I believe PPMS. Positive clinical trial
    For PPMS. It maybe approved in the next six months. The difference between rituximab and ocrelizumab is that the latter is a fully humanized monoclonal antibody with less infusion related side effects. I know rituximab is used off label for MS and is off patent.

  6. David F says:

    I have been taking Rituxan since January 2016 – had my second set of doses in July. I can count myself among those doing wonderfully on this medication. Last year I had two relapses requiring IV Solumedrol and the symptoms were far less inclined to abate than in the past. My baseline is such that I am not disabled physically, but my symptoms of dizziness, double-vision, feeling (not showing) incoordination, and cognitive slow-down are devastating to me invisible to others. I too went through an appeal process with my insurer and lost. Then- late in 2015 – my Neurologist sat down with one of the biggest providers in Massachusetts and they agreed to add MS to the list of diseases treated with Rituximab. Taking this drug has been the line in the sand from being unwell to now being well. There is no other explanation: remove cells integral to causing the MS inflammation process = get better. Obviously it won’t uncut a nerve that’s been permanently damaged, but it seems to be reducing flare in my case. I am so grateful for this.

  7. Claudia Olague says:

    I took my first dose of Rituxin in August. I have a lot of energy and not as much pain, but I am experiencing a lot of itching on my scalp, face, and hands. Also I feel I have some swelling. Has anyone experience itching reaction months after infusion?

    • Christine R says:

      YES YES YES – swelling in foot recently damaged but had it under control – had the infusion and BAMM – whoops there she goes – scratch inflammation GI tube area – much the same as ur describing…we shall see…wondering to continue

  8. Tracy says:

    Have been on retuxin for two years. Have had ms for over 25 and have tried them all due to a very sensitive system. this drug was fully approved for ms Jan 1, 2016. Before traveling to India just know that there is assistance to get this medication. I go to Stanford or el Camino so I know it is doable. Ask your Nero, clinic or hospital for help. This is a non curable chronic disability and even Medicare will find a way. There are minimal side effects and I haven’t had a flare up in two years. Stay informed and learn how to fight for your rights.

    • Linda Arena says:

      Thanks for your info… What did you mean by it was approved in Jan, 2016
      I would much prefer to have the treatments for my son done here rather than India. Any information towards getting done here would be so helpful.
      Linda

  9. Linda Neal says:

    I have already been on three different lab rat drugs Capaxone, Tysabri and Techfedera. Most of my problems came from these medications. I decided to do it my way holistically and since I have improved greatly.

    • Dawn says:

      Thanks for your info. What have you been doing holistically? I’ll try anything that isn’t going to cause a fatal brain infection.

      • Jeffrey Lagomacini says:

        Holistically, honestly not much……. (other than a few Ketel One martini’s during the week).

        I do try to meditate everyday, sometimes I forget, but I average five out of the seven days in a week. Also, I am pending the State of Florida to finalize their procedure in order to apply and receive my medical marijuana card. Everything should be in place for this October. Let’s see

  10. Margaret says:

    Hi. I was on RITUXAN every 6 months for my MS. My last dose was Oct 6th 2016. I always had much energy after every dose, but this time I felt different.

    I was very weak. Within 2weeks I developed a cold. A cold is quite odd for me, I haven’t had a cold in 8 years!
    Within 2 weeks from then (after my cold), again the weakness came back and now I had a chest cold.

    Overwhelming weakness and 103.5 temp and I was taken to Hospital via ambulance.

    My lungs were in COMPLETE “whiteout” double pneumonia, hypoxia, sepsis, Respitory failure, 2 IV’s a pick line, steroids and 4 antibiotics!
    See, I was always concerned about PML and rightly so, but I never researched how Rituxan may effect the Respiratory System.
    I am in no way inplying Rituxan will effect everyone the way it did me, we all must weight the risks vs benifits.

    http://erj.ersjournals.com/content/35/3/681
    I read this journal after I got well, my Infectious Disease Doctor also had to search the web for this paper…he agreed it was something he was unaware of.
    I wish everyone well.
    Margaret~

    • Tim Bossie says:

      Hey Margaret! Thank you for sharing your experience. We are truly sorry you had this type of reaction to the drug, but you are right. Not everyone has the same experiences… some do quite well, while others have reactions (both immediate and after a few treatments).

    • Rhea P says:

      I’m so sorry to hear that. I was on plegridy and aubagio. Both of these attacked my lungs and gave me pneumonia. I was in icu on the aubagio. Now I’m on Rituxin I have had five treatments so far so good. I hope u find something that works for you.

  11. Heather B says:

    I will be getting rituxamab infusions starting in a couple of weeks. My neuro is making sure I get immunizations before we start. I am very very afraid of PML since that really can’t be treated. I’ve read all of your comments and it makes me feel a little more at ease. There are so many other serious side effects that go along with it. To be honest I’m very scared! I’m not currently taking any meds for my MS. I’ve already had 2 relapse within 2 months so I am anxious to start treatment. At the same time I’m terrified! I know the stats but does the positive really outweigh the negative? Looking for certainty I guess. For the first 7 years I didn’t have any symptoms other than ocular neuritis. Which improved after steroid treatment.
    Thanks for reading .

    • Bridget says:

      I am responding to Heather B’s questions….I am in a very similar boat and am about to start Rituxan in a few weeks as well. I just was diagnosed with MS in June 2017. I had one exacerbation in May which led to my diagnosis, was treated with IV steroids for five days and my symptoms improved by 50%. About two months later I experienced a second exacerbation with optic neuritis. I have not been on any medication besides the IV steroids and i’m also extremely scared to start the Rituxan. Heather, have you started the Rituxan? How has it been for you? I am wondering about side effects as I am an independent contractor and do not have paid leave or vacation and I’m wondering if I will be able to work after the first two infusions. My doctor wants to set up two infusions two weeks apart for the initial treatment

  12. Deepak Grover says:

    What is the dosage for rituxan. I know the dosage for ocrevus is 300 mg initially and another 300 mg after 2 weeks and then 600mg every 6 months. Is it the same protocol and dosage for rituxan infusion

    • Deepak,

      I have been on the following dosage for three years until recently: 1000 mg x 2 doses (every six months). Each doses is given 2 weeks apart. For a total of four (4) infusions per year
      Starting January 2017, I have maintained the same 1000mg but it will be administered by infusion once per year instead of every six (6) months.

      I hope this helps….

      • Deepak Grover says:

        Thanks jeffrey, appreciate the info. where are you getting the infusions done. My son has PPMS. He had HSCT done in Tel Aviv at Prof Slavin,s CTCI clinic over 3 years ago. We are looking at Rituxan infusions on a preventive basis. However in canada doctors and neurologists will not use rituxan for ms since it is not approved. Also Ocrevus has only been approved for RRMS at this time canada.

  13. Lisa Berube says:

    What’s pml mean? I’m also not on any MS meds but will be starting my first infusion of rituxan nect friday. Also what’s the GI issue about that I’m reading in comments? I’m concerned also when someone said pml.

  14. Julia Badon says:

    Hello all. I have been on Rhituxan for 3 years now. I have Kaiser, I don’t pay anything for the Rhituxan infusion, not even a copay. Kaiser Permanente has its bad side, but this has got to be one of the best parts.
    So maybe it’s worth investing in for those unfortunate to have to travel out of the country for an infusion. That’s terrible. My heart really goes out to you.

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