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.

54 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

        • Tanya Smith says:

          Mike it’s always good to hear that your experience with Lemtrada was a good one. I am currently switching from g to Lemtrada, so I find your story hopeful

    • 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

    • Lisa says:

      Hi. I just went on Gilyenia in Jan 2019. Between the middle of Feb to the end of March my liver enzymes went thru the roof, over 1,000. My neurologist said it had nothing to do with the medicine. I am in the hospital now because of my liver and am off the Gilenya since being in here for a week. I don’t want to go back on it, due to the side effects after stopping, and I am curious to see if my liver enzymes go down. Did yours? How long did it take?

  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).

    • Amber says:

      You’re probably going to dislike this, but gilenya made me tremor,I could no longer write or even speak without a tremor in my voice. My legs hurt and I feel so tired all the time… The only thing that helps is cannabis. It’s not legal in my state, but it stops the tremors, pain, and fatigue. I want to stop taking gilenya and just use cannabis and iodine… Just saying…

    • Laura Galiotto says:

      Chris can I ask how things went when you stopped? My husband stopped about 3mis ago and keeps saying his head is not right. He feels depressed. Now alot has happened over the year. I the primary source of income had to stop working. I’m preparing for surgery next week but worried. He wouldn’t say something unless it’s really bothering him.i work in the medical field after talking to him about what he is depressed or feel off about he can’t explain it. Now I’ve got a 50/50 ,it is either the stressful year not only for I but for him too or the sudden stop of Gilenya. I’m glad they began looking into it.

  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

      • Christina says:

        Hi. I stopped Gylenia in October coz this doctor in russia advised me to come off n go on herbs. have rebound. Numb spasticity in hands .so scared. It’s going on for month now. How do you feel now?I’m on
        Ivig infusionso 2 days ☺

  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!

      • Angela D.. says:

        I am about to try Ocrevus and my neuro wants me to stop Gilenya for a month b4 i start Ocrevus. I have not had any relapses for the 3 yrs ive been on it but my symptoms are worsening so she suggested this course change. Im terrified of a relapse b4 I start the Ocrevus but with worsening symptoms… she fears i may be transitioning to SPMS. UGH!

  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.

    • Robyn Pattrick says:

      I’m like you Carol, no symptoms really, I’ve been on Gilenya about three years and I’d like to stop taking it. I don’t like the side effects.

    • Juliana says:

      I’m also thinking on going off fingolimod. I’ve been taking it for 7 years and 3 months and I have almost no symptoms neither side effects. From the article and comments, it seems like it’s a risky move to come off medication.

  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

  10. Jennifer says:

    I have been off of Gilenya now since September 12th of this year and am now having a major relapse with 30 or more new active lesions. My doctor wants me to take steroid ivy therapy for a week and then start tysabri the following week. I’m still currently taking my tecfidera. Should I stop this? Are these symptoms permanent? Please help. Thank you.

  11. Stacey says:

    I am having a shoulder replacement in April I am on Gilenya and have to stop Gilenya 2 weeks before surgery and 2 weeks after because of infection has anybody stopped and restarted with any problems

    • Tanya lindsey says:

      I had to do the same and had no problems i don’t think. I did get really sick after and was in and out of the hospital for the rest of the year but the dx was COPD. No new or worsening lesions. Hope this helps.

    • PSL Tanner says:

      Hi, I stopped Gilenya cold turkey after 2 years of being on it. My doc took me off it due to back-to-back bouts of pneumonia. I experienced NO relapse symptoms whatsoever. I went back on it about a year later (couldn’t tolerate Tecfidera). I’m now about to go off it yet again to try to get pregnant. I wasn’t worried about it but now I am after reading these stories!

  12. LUANN says:

    I WAS RECENTLY TAKEN OFF GILENYA AFTER TAKING IT FOR 5 YEARS. AM SUPPOSED TO START OCREVIST SOON DUE TO SOME WORSENING SYMPTOMS (I.E. COGNITION,BALANCE,MEMORY,COORDINATION. DOES ANYBODY WHO HAS GONE THROUGH THIS HAVE ANY ADVISE OR “WORDS OF WISDOM”?

    • Ann says:

      I will have my first Ocrevus infusion in 2 weeks. Been off Gilenya for 2 weeks already. Rapid relapse within days of stopping Gilenya. Already had 3 days solumedrol which helped for about 2 days. Had I known this would happen, I NEVER would have stopped Gilenya to start Ocrevus. This is just so wrong!

    • Leanne Charles says:

      J have just gone off Gilenya after 2years it seems it can aggravate heart disease which I now have and had to havestents then a triple Bypass only3 mo this later . I have had to stop it for 6 weeks ro let my lymphocytesbuild back up and then I will begin Intavenous Ocrevus as my new MS drug . It’s not looking good re relapses going by the comments here. Feeling nervous 😬

  13. Kaura says:

    I hate the idea of being dependent on a modern medication, but I started Fingolimod because it was the lesser of the evils it seemed without death as a possible side effect. I was on Copaxone before but it made me worse and left bruises. I eat extremely well and I’m on a vegan/ vegetarian diet. I maintain what I consume down to a science. All of my vitamins, nutrients, etc, levels are perfect but my white blood cell count has been steadily falling this past year that I have been on this medication. 1.8 at the moment to be exact and falling still. When I started the medication I was at 7 which is normal. About 4.8 to 10.5 is normal. One neurologist desperately wants me off the medication While others are afraid of the side effects related to the other medications. I would love to find a way to safely get off this medication and just continue pursuing alternatives. Maybe if I see no results in a year or two after I start that, if I can even start that, I could observe and see if I have improved or if I should stop. This is terrifying. I’m sure it is for everyone else as well.

  14. Francesca Fox says:

    I am 29 years old and stopped Gilenya in January. Within one month I started relapsing. I have been through two rounds of steroids and they helped to an extent, but the rebound was too strong. I was on Copaxone to try and hold me over through pregnancy, but it did NOT work. There needs to be more research on the phenomenon as it is quite debilitating. I’m going to a specialist today to discuss my options to fight this monster relapse. Be very careful in stopping Gilenya.

  15. Chris says:

    I was on gilenya from 2013-15, right when I was diagnosed. I stopped it to get pregnant. Had a big relapse after 6 weeks started again gilenya after 2 months and almost recovered from the symptoms. Took it for 2 years my clinical state was great but the MRIs showed new lessons.my doctor decided to switch I stopped again end of march and since may I experienced a huge relapse like never before. Had I known this I would have never stopped!or even re-enter a drug that causes so much trouble stopping!

  16. Nour says:

    Hi all
    I am on Gelinya for 4 years now… Last year due to money issue I start taking it every other day…one day I take it the other day I don’t… Dr. Did not advise that…now it’s a year I am doing that… And everything is ok thanks God… Just wanted to share with you … God blessings

  17. Ali says:

    Hello all
    I was on Copaxone for more than 10yrs. This year I had some new lesions(big ones) that I was advised to switch it to Gilenya. After using this drug for about 4 weeks it gave me PVC and very low heart rate. At this moment I am off of Gilenya just around less than a week but I am having severe relapses, fatigue, numbness on my both arms and legs, dizziness and crazy irregular heart beat that made me so worry. I am going to start Ocrevus soon as I was advised by my neuro (probably in a month or so)but I just started Copaxone to fill this short period of time with something.
    I also am just curious how the Canadian Medical System covers the cost of doctor visits, medications and MRI. Is there a co-pay or it’s all covered by the government? If not how much is the out of pocket?
    Thank you!

    • Tanya Smith says:

      Hi Ali

      I am from Canada , but I can only tell you based upon my experience.. I don’t know about other provinces but where I have been on rebif, tysabri and now Gilenya and am about to start Lemtrada with every individual drug there is a program as well as the goverment that pays for these medications for me, for example the Gilenya go program and for Lemtrada the ms one on one program . I have never had to pay anything in the last 21 years for any ms meds, other prescriptions yes but not anything to do with ms medications

  18. Chris says:

    Been on Gilenya for 8 years. Got skin cancer (mm) so am going off since Gilenya increases risk of cancer. Holding my breath I don’t relapse.

  19. Kate says:

    I came off Gilenya (that i fought so hard to get onto) because it suppressed my immune system to a dangerous level. A few months later i had such a severe rebound relapse. My Neurologist said i had “catastrophic brain damage”. I went from being totally independent to having to call my Mum to come rescue me and then i was totally dependent on people for everything. Feeding me, dressing me, holding a cup up to my f£$%ing mouth. Then i was told i had to have a course of Lemtrada of i could be left with locked-in syndrome (so it felt like i had no choice!). That did nothing positive and after it they found cancerous cells in my uterus. Probably a side effect of the “chemo”. Years later i am still recovering. This is not my MS, this is Novartis not testing their drugs sufficiently. I would not recommend. Holistic treatment all the way!

  20. Robyn says:

    I’ve been on Gilenya about three years and I’d love to stop taking it, I have this ‘heart thumping feeling’ every night that makes me feel very nervous. But reading all these comments about relapses, I’m too scared to stop it!

    • Judy Meininger says:

      I have also been taking Gilenya for over 5 years and also, like you, am scared to stop it after reading all of this. What I want to know is why now am I finding this out from a FB page post when this article has a 2016 date on it? Why aren’t our docs and the specialty pharmacies making this known to us? Feeling frustrated and overwhelmed.

  21. Pennie Humphrey says:

    March 3, 2019

    I was diagnosed with RRMS in August 1991. Optical Neuritus was determined and I went into remission in about six weeks. My first neurologist retired and I began working with a new neurologist.

    I eventually started taking Gylenia and was on it for over five years.
    My third neurologist ordered some lab work to determine if I was at risk for PVL-the immunologist called and told me to stop taking Gylenia. I was off of it for a minimal amount of time with no relapse and I started with Ocrevus and had a third infusion in January. I never had any side effects taking Gylenia, and haven’t with Ocrevus .

  22. Jennifer Cady says:

    I just quit taking gilenya about a month ago and I’m going to start on ocrevus. I didn’t read about the side effects of stopping the gilenya because I figured if I read them I probably would get them. LOL but my daughter asked me how I was feeling and I said different I couldn’t explain how, and then I read some of the information about possible side effects of going off gilenya and oh yeah, I have several, my thinking is more foggy, and my balance is worse, and I wish my neurologist would have talked to me about these.

  23. Sarah says:

    I was on gilenya for 7 years had to come off due to low lymphocytes and have had a terrible time with the rebound effect , oscillating eye sight , blind spots and then big flare with balance and leg weakness.
    I went on tysabri which increased my flare and brought on intense neuropathic pain I felt awful.
    The lack of information about the rebound effect on stopping gilenya followed by being put on tysabri whilst in flare and ending up in hospital is hard to accept.
    I am now on nothing rebound problems still with me and I am clinging to my vegan diet .
    Not sure what my next step is now

  24. Ann says:

    I’ve been off Gilenya for about three weeks now to get ready to start Ocrevus. Midday fatigue is what I am noticing most – I hope to heck it doesn’t get worse than this.

    On that note..time to head home for a while before picking up the work again.

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