Long-term Rituxan Treatment Is Effective and Safe in MS, Study Shows

Long-term Rituxan Treatment Is Effective and Safe in MS, Study Shows

The approved lymphoma therapy Rituxan (rituximab) has shown promise as a treatment for  multiple sclerosis.

A new study indicates the Genentech treatment is effective and safe against neurological diseases like MS for up to seven years.

The research, “Long-term safety of rituximab induced peripheral B-cell depletion in autoimmune neurological diseases,” was published in the journal PLOS One.

Rituxan targets a protein called CD20 in immune B-cells, which are responsible for the production of antibodies. The U.S. Food and Drug Administration (FDA) approved Rituxan as a treatment for lymphoma and rheumatoid arthritis.

The antibody in Rituxan leads to a depletion of certain B-cells. It is currently being investigated as a potential therapy for relapsing–remitting multiple sclerosis.

In fact, “rituximab is often used as an off-label therapy in patients with immune-mediated neurological disorders (PIMND), including multiple sclerosis,” the researchers wrote.

Off-label use means Rituxan is prescribed as a therapy for diseases other than those for which it was approved.

While open-label and randomized controlled studies have shown promising results for Rituxan in disorders other than lymphoma or rheumatoid arthritis, scientists have had long-term safety concerns about it. Those concerns are particularly important because Rituxan can be prescribed for years.

A team of researchers decided to examine the “long-term safety, incidence of infections, and malignancies in subjects receiving continuous therapy with the B-cell-depleting agent rituximab over at least three years or longer.”

They looked at the records of multiple sclerosis who had received Rituxan a minimum of 18 months. The analysis included patients with neuromyelitis optica and myasthenia gravis treated with Rituxan for the same period.

The primary endpoint of the study was to assess rituxan’s long-term safety —  in terms of adverse and serious adverse events — in patients treated between three and seven years without interruption.

Patients received Rituxan intravenously in 1,000 mg doses administered twice a year or every six to nine months. The number of B-cells in their blood was determined at baseline and before each treatment cycle, and a medical evaluation was performed every three months.

The analysis included 29 patients — 22 women and seven men. Five patients had multiple sclerosis, three myasthenia gravis, and 21 neuromyelitis optica.

“We observed complete depletion of circulating B-cells in the majority of the patients and marked depletion in some of the patients throughout the treatment period,” the researchers wrote.

Rituxan was well tolerated, and the rate of adverse and serious adverse events was low. Also, “there were no cases of progressive multifocal leukoencephalopathy (PML) or malignancies observed throughout the observation period,” the team wrote.

PML is a rare brain infection that has been associated with long-term use of some therapies.

“This study demonstrates that long-term depletion of peripheral B-cells appears safe and efficacious in treating PIMND. Longer and larger prospective studies with rituximab are needed to carefully ascertain risks associated with chronic B-cell depletion, including malignancies,” researchers wrote.

They emphasized that although this was a small study, the results “complement the growing literature [scientific studies] documenting the safety and tolerability of B-cell-depleting agents in neurological diseases.”

20 comments

  1. Clive Arup says:

    I’ve been treated with Rituximab for the last seven years for RA but also have had PPMS since diagnosis in 1997. It’s been great for RA and who knows re the MS – might have done some good. Anyway well tolerated and reduced dosage to single infusion approx once per year now.

  2. Steven Johnson says:

    I have secondary progressive MS. I was just started on rituxin last summer. This article encourages me a great deal. I’ve had no adverse effects & I’m due for my next round of infusions in the very near future. Have any studies included secondary progressive patients?

  3. Scotty says:

    I also have secondary progressive MS and have been on Rituxan for over 3 years with no adverse effects. My neurologist, my wife, and I all believe that it is working/helping. During the past 3 years while on Rituxan, I have had the least amount of progression/symptoms that I have experienced in any other 3 year period of my 30 years with the disease.

    I also retired from my teaching job which may also have helped?

    • julie lowndes says:

      I have secondary progressive MS. I have a lot of spascity that is getting worse. I’m wondering if this medication would slow this progression down?

  4. Ally Grant says:

    I was prescribed 5X 500mg doses over the course of a year of Rituximab as a follow-up medication after my HSCT treatment for my RRMS to kill off any ‘rogue’ MS cells that may have remained after the chemotherapy had done its work and it certainly appears to have done that.

  5. Jose Johnson says:

    I have been taking Rituximab for primary progressive MS over 18 months. I get an IV every six months. I now plan to get a stem cell treatment. I do not want the Rituximab to interfere with the new injected stem cells. Question: How long does Rituximab stay in the system?

  6. Karen says:

    Has anyone experienced hair thinning or loss? I have RRMS and have just begun rituxan treatment and am very concerned about this particular side affect.

  7. Gary Jarvis says:

    Does the Rituxan have a limit on how much you can take like Methotrexate does. Do tests have to be done before each dose of Rituxan is given such as ejection fraction of the heart. Thank you.

  8. T. Young says:

    The Rituxan seems to be helping although I often experience a burning sensation in my abdominal area. Because Rituxan is off labeled for the MS disease, my copayment is extremely high. Is there a resource that provides assistance to help pay for the treatment?
    ( We are still paying off the first infusion).

    • Lauren says:

      Yes! The company has a copay assistance program. There should be info on their website. Or Google rituxan copay assistance. Good luck!

  9. Ishrat says:

    I get 4 doses of Rituximab 500mg once in a week for 4 weeks in a month.. Then stop for 6 month and then my doctor increased the dose to 600mg… I dont know why. And how long i have to take this!

  10. I was diagnosed with Tumefactive Multiple Sclerosis (just a rare form of RRMS where one or more lesion resemble brain tumors) back in March of 2012. Started treatment immediately on Avonex the side effects of that were worse then my MS symptoms after about a year of absolute misery I switched to Tecfidera which has seemed to work well since then however I just last month had a fairly sever exasterbation that lasted two weeks and hospitalized me for 5 days. It took Two doses of steroids to get back to my baseline but at least I recovered.. MRI showed one new active lesion on my spine so now my Nuroligist wants me to switch to Rituxan so I’ve been dong a lot of research and so far it all sounds promising. The only thing I’ve come across is one study where extended use of Rituxan can increase your risk for secondary infections such as pneumonia, which, at least for me, means a relapse and certain hospitalization. So my question is has anyone experienced any secondary infections due to suppressed immune system from long term use of Rituxan?

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