Severe Rebound Effects Found in ‘Relevant’ Number of MS Patients After Stopping Fingolimod

Severe Rebound Effects Found in ‘Relevant’ Number of MS Patients After Stopping Fingolimod

Rebound symptoms after stopping fingolimod (Gilenya) treatment affect a “clinically relevant” number of multiple sclerosis (MS) patients, a study by University of California, San Francisco, researchers reported. The study called attention to the need for determining the best method of sequencing or stopping MS treatments, and highlighted the need to identify factors that increase the risk of severe symptoms after fingolimod cessation.

The change or discontinuation of immunoactive drugs is a sensitive matter, balancing safety and protection against relapse, and is of particular concern to women stopping treatment because of pregnancy. The occurrence of rebound symptoms after fingolimod treatment, however, is not well-studied.

Rebound effects are the re-emergence of symptoms held under control by a treatment once the treatment is stopped. The study, published in the journal JAMA Neurology, investigated electronic medical records, along with magnetic resonance images (MRI), from the UCSF Multiple Sclerosis Center for evidence of rebound symptoms after fingolimod cessation. Records from January 2014 to December 2015 were included in the analysis.

Fingolimod is a drug that targets immune cells in the lymph nodes, preventing them from entering the central nervous system. When the treatment is stopped, the pool of peripheral immune cells is back to normal within four to eight weeks.

Among the 46 patients who had stopped fingolimod treatment during the period analyzed, five women, amounting to 10.9 percent of the group, developed rebound symptoms in the form of severe relapses that occurred four to 16 weeks after discontinuation of treatment. This time span mirrors the time it might take for immune cells to re-enter the brain.

Before the investigated relapse, the five had varying degrees of severity in their relapsing-remitting course. But the study, Rebound Syndrome in Patients With Multiple Sclerosis After Cessation of Fingolimod Treatment, reported that all five women suffered an unusually severe relapse after stopping fingolimod treatment.

MRI scans showed that patients had a median of nine new gadolinium-enhancing lesions, and a median of nine new T2 lesions. Although patients were treated with corticosteroids or B-cell depleting therapy, new lesions continued to form for another three to six months.

In an attempt to further evaluate the extent of the problem, the research team reviewed the literature for similar cases, and identified another 11 patients who experienced severe relapses after stopping fingolimod treatment, indicating rebound effects.

The study showed that the proportion of patients experiencing relapses after treatment discontinuation is clinically relevant, but the best way to prevent this from happening is far from clear. Also, scientists and clinicians are still in the dark about who might be at risk to develop rebound symptoms, pinpointing the need for large prospective trials to determine best clinical practices.

19 comments

  1. Pina Spadaro. says:

    Estimados, también interrumpir el Interferón (Avonex) recibido durante 5 años consecutivos es muy perjudicial.
    En mi caso particular pasé de no tener nada a ser progresiva a los 3 años sin poder detenerla con nada.
    Y mas lesiones en la médula y cerebro, es una injusticia (No se debe hacer)
    Atentos saludos, Pina.

  2. Mike Hemingway says:

    What is described in this article is pretty much what happened to me after I stopped Fingolimod. My severe relapse lasted about 15 months. I’m glad that research will look at a better method for stopping Fingolimod and other immune suppressive treatments.

      • Mike Hemingway says:

        I stopped because the Gilenya wasn’t really working. My MS was “rumbling along,” as my neurologist says. I then went on to Teriflunamide (I can’t remember the brand name) which also wasn’t great. I had been on Tysabri which was great but my JC virus antibody count was through the roof so I stopped. I’ve had the first infusions of Lemtrada (Alemtuzimab) about 9 months ago and that seems to be doing some good, which is great.

        • Matt Craig says:

          Hi Mike, Are you in the RR category or the SPMS.? My sister is in the SPMS category and doesn’t know what’s best, come off Fingo thats not working or risk the rebound and try Ocrelizumab/Tysabri

    • Mona el wassefy says:

      I am already on fingoli
      mod but why did you stop it!!
      My Egyptian prof Dr advised me never to stop it!!

  3. Debbie says:

    I had to stop due to extremely high liver enzymes that was in December 2012 and they still cannot find anuthing to work for me. I am worse now than before starting Gilenya. My MS is progressing sat a fast rate. Am on Tysabri only had a slightly visible form of the JC Virus. Waiting till the new med comes out for PPMS and SPMS

    • Mona el wassefy says:

      Am sorry for you but did you try changing you dietry habits
      There is a talk in Ted ex for an American dr named Terry wahls may you please found the talk buy her book too it may help controlling your illness
      God bless you

  4. Chris says:

    I too am a Gilenya prisoner. The great fear of apocalyptic rebound, instilled in me by my Neurologist (who is paid $150,000 in speaking fees by the drug manufacturer according to the disclosure reports on NIH.gov, btw), keeps me from kicking My $59,000/year drug habit. I am eagerly looking for ANY moderating protocol since my neurologist will not offer any advice other than “don’t stop taking your Gilenya.”
    (PS: please refrain from recommending diet or bee-sting therapies).
    Since I have been unable to find any (reputable) documentation, I will need to proceed AMA. If any researcher is interested in using my case for research, I plan to end Gilenya usage in November 16 (come what may).

  5. Canada79 says:

    I went off Gilenya on July 20th 2015 to try to get preganant. In early November I had double-vision and severe numbness in my feet. I have also noticed disease progression because I can no longer work out, run, and have difficulty walking normally. On top of that, I failed to conceive so it was all for nothing. IN hindsight, I would never have gone off the drug. I am devastated that my disease has progressed at the rate it has and worry that I’m now SPMS. I’m only 37. I am back on the drug as of Mar.10 but feel my MS has gotten worse. I am having to now take Baclofen for muscle spasms which I’ve never experiences before. 🙁

    • Jodi Feltham says:

      Reading your story is like reading my own in detail. I did two rounds of Lemtrada but i lost so much going off Gilenya. Reading your story makes me feel not so alone. I hope we can talk/email

  6. Joshua Klipsch says:

    My mother has been on Gilenya for years now. She was forced to go off of it recently because of a clerical error filling out some paperwork that discontinued her prescription. She’s 60 years old and confined to a chair. Since going off (maybe a month now) she’s experienced a severe relapse. After about a month there was a sudden increase of several alarming symptoms. She’s been unable to speak well (can’t find words or put sentences together), her vision has been VERY highly impaired (blurriness and discoloration), and her memory and cognition seem to be highly effected (having trouble identifying objects and remember where things are). We’re trying to rectify the lapse in the medication with the providers and we were told she’ll have to be monitored when resuming dosage. In the meantime she’s been barely functional on her own and incredibly frustrated. My question is how long will she be effected this way? How long does the relapse period last? Are there treatment options from this point? Can she expect to recover some of these faculties after a certain period or when she resumes dosages? Should she even continue using it? Any information about the permanence of these symptoms would be very helpful.

    • Mike Hemingway says:

      I was on Gilenya for just several years. With my doctor, we decided to change my medication. After going off Gilenya, I had a relapse that went on for about 18 months. The symptoms are better than at their worst but I am now, 5 years or more after going off Gilenya, more unwell than I was prior to going off Gilenya.

  7. James Warner. says:

    Are there any drugs available to help reduce rebound effect? My son is SPMS and in wheelchair. Brain lesions are minimal but spine has many. Been on Tysabri for 10 years and JC positive. Stopping Tysabri soon and starting Oclelizmab.

    • I had a discussion regarding this matter with my neurologist the last time I saw him. I have been on Gilenya for 3 1/2 years now and haven’t had any major relapses which of course I’m greatful for. However.. I am noticing some progression of the disease which raises the question should I switch treatment anyway… my neurologist said there is no medicine available to transition you from one medicine to the other. So what he does is takes you off the Gilenya for example and 24 hours later would do the first Tysabri infusion… by doing this it would prevent most likely any major relapse changing medications.
      Hope this information helps!

  8. Carol says:

    I found this article and comments really useful thank you. I have RRMS and have taken Copaxone, Tysabri and Gillenya over the last four years. I have almost no symptoms and I would like to find out more about coming off medication entirely. From the little I’ve read so far it seems like a risky move.

  9. Jocelyne says:

    I have been taking Gilenya for 3 years now, and it’s been going pretty well. About 3 weeks ago the doctors office failed to put through the authorization for the refill. I was off Gilenya for a week and am now experiencing a relapse, as shows on MRI. It confirms for me that despite the side effects of the Gilenya, it is helping with the MS. But it’s also scary to think that a relapse can come on so easily and the doctors office doesn’t take it so seriously.🙁

    • Mona says:

      Dear Jocelyn
      I also on p
      Gilenya for three years but I realised that my nephrologist advised me never to stop it and gave me a break not more than a week if I couldn’t have my medicine so I remembered missing gilenya for three or four times
      This rapid relapse that you have was it possibly proceeded by stress or infection?? Wish you all the best

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