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

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MS drug study

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.”

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  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.


      • Claudia Chamberlain says:

        Yes, I arranged for the trip online with Indian Med Trip 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.

    • 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!!

  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,

  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’.

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

  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?

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