Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows

Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows

Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) are equally effective in treating multiple sclerosis (MS), but Tecfidera shows higher rates of discontinuation, according to a real-world study.

The study, “Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,” was published in the journal Neurology Clinical Practice.

Tecfidera (marketed by Biogen) and Gilenya (marketed by Novartis) are approved oral disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis (RRMS). So far, no randomized, controlled trial has compared the effectiveness and discontinuation of these therapies, but real-world studies of MS patients at several sites may help fill this knowledge gap.

A recent study of RRMS patients in Italy suggested that Tecfidera and Gilenya are equally effective. While another study showed that patients receiving Tecfidera are more likely to stop treatment than those on Gilenya, due to adverse side effects.

To clarify these results in a larger population involving more than one site, researchers compared the effectiveness and discontinuation rates of Tecfidera and Gilenya for two years in MS patients treated at two large academic MS centers.

The team noted that the study included patients with RRMS or progressive MS to demonstrate the real-world experience of the use of disease-modifying therapies.

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Researchers retrospectively analyzed data of 737 patients treated with Tecfidera and 535 treated with Gilenya at the Cleveland Clinic Mellen Center, in Ohio, and the Rocky Mountain MS Center at the University of Colorado.

Most patients were women, white, had RRMS, and had MS for about 13 years. Mean age of patients receiving Tecfidera was 46.4 years, and for those treated with Gilenya mean age was 43.3 years.

The team found no significant differences in effectiveness between Tecfidera and Gilenya in MS patients, with 61.2% of Tecfidera patients and 63.4% of Gilenya patients showing no disease activity after two years.

However, men and patients with RRMS had a higher likelihood of developing more brain lesions with Tecfidera than with Gilenya. Also, patients who had not received treatment before Tecfidera showed a greater likelihood of relapse compared with those receiving Gilenya as first-line therapy, suggesting a reduced effectiveness of Tecfidera as first-line treatment.

Interestingly, the proportion of MS patients, including RRMS patients, who had relapses during treatment was lower than those reported in Phase 3 clinical trials, confirming treatment effectiveness in the real-world.

This difference may be a result of the inclusion in the study of older patients with both active and inactive disease activity at the beginning of treatment, whereas clinical trials were restricted to young patients with recent disease activity.

Regarding discontinuation, significantly more patients treated with Tecfidera (44.2%) stopped treatment, compared with those receiving Gilenya (34.8%), and discontinuation occurred earlier in Tecfidera patients.

In both groups, the most common reason for discontinuation was intolerability, but Tecfidera patients were significantly more likely to stop therapy because of intolerability issues (56.1% versus 46.3% in the Gilenya group).

Gastrointestinal problems with Tecfidera (57.9%) and headaches with Gilenya (14%) were the main intolerability issues leading to discontinuation.

No difference was found between both treatments regarding discontinuation due to disease activity — 10% with Tecfidera versus 11.4% with Gilenya.

Interestingly, the team noted, women discontinued Tecfidera therapy more due to intolerability than men, which was consistent with previous reports.

“The observed sex differences in DMT [Tecfidera] discontinuation may be clinically relevant and warrant further investigation,” the researchers wrote.

Older patients also were more likely do discontinue Tecfidera treatment compared to Gilenya.

Overall, the team concluded that this real-world data confirms the results of previous studies demonstrating similar effectiveness between Tecfidera and Gilenya, and an increased chance of discontinuing Tecfidera treatment compared with Gilenya, largely due to intolerability issues.

20 comments

  1. Wendy Lowe says:

    Tecfidera gave me acne. 18 months after stopping needed sepsis operation to remove cyst. Started as zit, then boil, then almost killed me! My skin has rashes and break-outs all the time since Tecfidera. I wonder if my skin’s self management has now permanently failed. I’d never suffered spots, even as a teen but here I am 43 and recovering from extreme reaction to wasp stings.Tecfedira is the worse DMD I’ve endured.

  2. Anita Phillips says:

    I have been on tecfedria now for abou5 4 years an the side affected I have from it is flushing alot off an on I itch on my arms it’s more nerve racking then any thing else no new lessions have come up which I’m ok still have other problems tha5 go with me too

    • Brenda says:

      Hi Anita,

      Thanks for your feedback. It’s interesting that you have been on Tecfidera 4/5 years (like me as well) and I still have the flushing/itching as well. When that happens I just take 3 (off brand – over the counter) ibuprofens (about 600 mlg) and the flushing/itching feelings go away. I like the tecfidera drug because it really work for me. Haven’t had a release in almost 4 years but that one side effect just get on my last nerve.

      • Diana says:

        I took Tecfidera from Summer 2006 to End of April 2019. Bc of Prescription D. & could not get my Monthly 30 day supply Tecfidera was not able to take my treatment May & June. Well got to find out all my symptoms return itching my right arm & u itch you don’t feel, my leg spams, itching front bk brain & much more. Well I will turn 37 in sept. Was diagnosed Nov. 2012. My daughter it’s now 9yrs. Old. I always work out, lift weights and learn from Dr. Jerry Walsh smoothies, veggies 7 yrs ago. Last 2-3 yrs I don’t do Veggies smoothies I eat Organic Spinach, Red Kale Organic, 1 banana, 1 cup organic strawberries, & blueberries, grass fed meet, Perdue chicken, no white sugar. Organic honey, no coffee, Te, so, listening to Pam Bartha., & Thank You Jesus I diagnosed myself he place all the tools in my hands. Now they want me to try Gylenya. Going to follow the plan, but all bodies are different Tecfidera never did anything we to me. Actually it help me not to be hospitalized ever again & with steroids will see what GILENYA does

  3. Glenda says:

    If one truly wants to “first do no harm”, then avoid Tecfidera like the plague. The GI symptoms were horrific for me. I know that’s anecdotal, but it was a nightmare because I wanted so badly for it to work.

  4. Beth says:

    I’ve taken tecfidera for several years. At first the gastro effects were horrible. The only thing that worked for me was taking them with a slice or two of raw ginger. It took a little but those effects have passed. I had a bad skin reaction, and I found out that actually handling the pills was causing it, so I’m pretty careful with touching it as little as possible. And I’ve had a skin infection or two that took some time to pass.
    It’s not a perfect drug and it was hard to adjust to but it’s worked better for me than anything else ever did.

  5. Christopher says:

    I’ve been on Tecfidera for about a year. The side effects haven’t been pleasant but they have calmed down, they’re only annoying now. I’ve been on quite a few different MS drugs, if there’s a side effect I’ll get to deal with it! I haven’t had any relapses and to be honest I’m just glad I don’t have to give myself shots anymore.

  6. Brooke says:

    I have been on Tecfidera for over 6 months now and the only site effect has been flushing for me but I find that if I am drinking lots of water, at least a full glass every hour then the occasional flushing goes away within 20 mins.

  7. Kim says:

    I’ve been on Fingolimod (Gilenya) for 10 years now. I started in a clinical trail and have continued on. It’s been amazing. No side effects really. Lower immune system so I typically get the colds or flus going around but no other side effects! And no relapses for over 4 years after going off of it to have my kids. I highly recommend it!

  8. Catherine says:

    I have been on Tecfidera for two years and feel so lucky that all I have suffered is occasional flushing on my arms. I had an MRI recently, hopefully the drug is still working for me. I agree with Christopher, loads better than the avonex injections and the flu-like side effects with that.

  9. Don says:

    My MS is getting worse and my Dr Recommends that I switch to Ocrevus or Aubagio. I have studied all the official literature, prescribing info, etc. What I really want to know is since the medicine has been available, what are real world experiences of efficacy and side effects from real people. Comments I have found about Ocrevus range from some terrific; more underwhelming, and probably most horrific and regretful. I can’t seem to find much on Aubagio, and I don’t know if that is meaningful in some way. The problem is the FDA doesn’t want to publicize problems until they are 100% sure. And comments from sites and pharma sponsored events are often one-sided. Any recommendations of where to find this information?

    • Leanne says:

      I too have to decide if to go off Gilenya because of progressive heart disease that has developed and go onto Ocrevus that increases the chances of some cancers. I have also rad mixed reviews . I’m
      Really struggling to make the decision . Would I be going from the fat to the fire with increased Gilenya rebound syndrome kicking in which could result in sever relapses. Dammed if I do and dammed if I don’t I say

  10. Lena says:

    About Aubagio:Common side effects of treatment include feeling sick, diarrhoea and hair thinning which can occur during the first few months of treatment but generally improve in following months. Increased blood levels of liver enzymes can also occur.Common side effects (affecting more than 1 person in 100)
    • increased levels of liver enzymes
    • nausea and diarrhoea
    • hair thinning and loss
    • urinary tract infection
    • inflammation of the nose and throat
    • influenza
    • pins and needles
    • infections
    • decrease in white blood cells (neutropenia)
    • mild allergic reactions
    • anxiety
    • nerve pain
    • decrease in red blood cells (anaemia)
    • increase in blood pressure
    • rash
    • musculoskeletal pain

  11. Pat says:

    Started on tecfidera 3 months ago. No side effects Couldn’t stand Avonex shots anymore. I’m on MEDICARE and this year 2019 they don’t cover tecfidera. So now what??? Have to see what I can afford or go back to shots

    • Renee says:

      There private funding available to help pay for medication. I am also on Medicare and have received funding which has been a tremendous help. I was able to start this process by contacting the drug manufacturer.

  12. Renee says:

    I recently stopped Tecfidera after ~ five years. I realized increased white matter brain lesions at an overwhelming rate, I later became aware that white matter brain syndrome is a possible risk associated with this drug and have valid concerns as to whether Tecfidera was a culprit. I am really sick and tired of being a guinea pig.

  13. Mary says:

    I have been on Tecfidera for at least 7yrs now. I have the flushing side effect and take a Bayer aspirin 30 mins before taking the med and do not get the flushing. I actually take the Bayer low dose. I have had some headaches but can not say that it is necessarly from the Tecfidera. I also take Ampyra which can also cause headache OR they could simply be from allergies!
    I have no new lesions since taking Tecfidera. It has worked very well for me!

  14. I was diagnosed with MS at age 54 in May 2010. I was on Copaxone for 2.5 years until I got tired of being a pin cushion. I then started Gilenya and have been taking it for 6 years. I love being on Gilenya ~ no side effects except for a headache that was easily taken care of with Excedrine Migraine. Since I started Gilenya, no new lesions have appeared in my brain or spine. I have never had an MS relapse since being on Gilenya. Just two months ago, my neurologist took me off of Gilenya and my liver enzymes are now almost back to normal. So, he decided to start me on Ocrevus. We have gone through all of the red tape & preparations for my first infusion which is supposed to be next week. Today, I received a letter in the mail from my (public school system) insurance company denying coverage for Ocrevus. I will not go back on an injectable medication and Tecfidera has proven to be not as effective (more lesions) as Gilenya. More people stop taking Tecfidera due to the many gastrointestinal side effects and break outs. I am going to call my neurologist tomorrow and tell him that I want to go back on Gilenya and maybe give my liver a rest every six months. Any thoughts?

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