Majority of RRMS Patients in Swedish Study Seen to Stop Using Tecfidera Within 2 Years
Written by |
A majority of relapsing-remitting multiple sclerosis (RRMS) patients at a Swedish clinic who initiated treatment with Tecfidera (dimethyl fumarate; DMF) either stopped or switched to another therapy within two years, a study reports.
Researchers in the observational study were not able to determine exact reasons for discontinuation. But, they wrote, “it is likely that lack of effectiveness, lack of tolerability, or a combination of the two contributed to the low persistence rates observed.”
When Tecfidera was approved to treat RRMS patients in the European Union in 2014 (in the U.S. in 2013), expectations promoted its rapid use. But high discontinuation rates seen among patients in pivotal clinical trials and a lack of real-world data on persistance in use of the treatment, marketed by Biogen, encouraged this study. (Lack of persistence was measured as treatment discontinuation for 60 or more days, or a decision to switch therapies)
The study, “Persistence with dimethyl fumarate in relapsing-remitting multiple sclerosis: a population-based cohort study,” was published in the European Journal of Clinical Pharmacology.”
“DMF was the first oral first-line DMT [disease-modifying therapy] introduced, and the initial market uptake was relatively rapid compared to that of other recently introduced DMTs, suggesting that the expectations for DMF were high at the time of introduction,” the researchers wrote.
The high expectations were linked to the therapy’s ease of use (oral administration) and potential effectiveness, such as in overcoming intolerance and preventing disease relapses.
Researchers collected data on 400 RRMS patients who initiated Tecfidera treatment in Stockholm County from May 2014 through May 2017. A majority (61 percent or 244 people) had used other DMTs, and patients were observed for a median of 2.5 years.
Results revealed that 124 patients (31 percent) stopped treatment during that time, and 114 patients (29 percent) switched to another disease-modifying therapy. Mean time to discontinuation was 366 days; mean time to switching was 372 days. One-third of all patients had stopped using Tecfidera within one year, and only 43 percent continued using Tecfidera at two years, the researchers reported.
Rituximab, a commonly used off-label MS treatment, was the therapy chosen by most patients who switched from Tecfidera — by 78 percent of those who had never used a DMT previously, and by 62 percent of those who had.
“The rapidly changing MS treatment landscape poses a challenge for clinicians to select the most optimal DMT for their patients,” the research team wrote. “Even though risk-benefit profiles of the new DMTs have been assessed in clinical trials, there are uncertainties about their effectiveness and safety as well as long-term outcomes when used in routine clinical practice.”
While researchers could not determine from the data exact reasons for discontinuation, they noted a rising use of off-label rituximab among RRMS patients in Stockholm County between 2014 and 2017, and the likely role of Tecfidera’s “lack of effectiveness, lack of tolerability, or a combination of the two” in influencing patients’ choices.
Stephen D. Danielson
I read the article entitled Majority of RRMS Patients in Swedish Study Seen to Stop Using Tecfidera Within 2 Years in your newsletter today. I tried Tecfidera a few years ago and it caused such violent gastro-intestinal problems that I had to stop taking it after four months.
Denise
I took it for almost 5 months and I was lucky to not have any abdominal issues BUT!!! Instead I had lost my appetite and I was slowly losing my sense of taste. By the 4th month I had realized it was gone and a few weeks later I thought it MUST be the tecfidera because I wasn't doing anything else that was different. I stopped the tecfidera and my sense of taste was back to 100 percent in a few weeks. That side affect was not listed. I reported it to the FDA and they acted like I made it up.
Vijitha Cheruvari
Oh, I am using the same, and it has started with me too. I have to take really spicy food to acknowledge the taste. Well, then comes the trouble with the tummy.
Beth A Blackmarr
I have found the same. Biogen does not want to acknowledge side effects. They have "Nurse Educators", who are really just a data-collection group. They hace offered NO HELP beyond what I could read myself in the brochure. The FDA only acts when they have a significant number of complaints on a particular drug. So, it seems daunting. Especially when I am feeling quite poorly to start with. Anyhow, hang in there.
Annette
I have been on tecfidera for about 3 years now, only get upset stomach if I don't eat when I take it, I get headaches, but my neurologist says they are migraines. Other than that it has held my disease in check, and all good so far.
Raven
I took Tecfidera for almost a year. It was my first MS drug after I had been diagnosed. My hair started to fall out, it gave me severe anxiety, I had a symptom flare where I couldn’t walk at least every other week, I was breaking out in hives, and I suddenly became allergic to strawberries when I would eat them after taking the medicine. My doctor at the time refused to change the medicine until I had been on it a year. So I switched doctors, and they were obviously very concerned with my symptoms to Tecfidera. Once I stopped the Tecfidera, my hair started growing again, I came off anxiety medicine, and I was able to stop taking Benadryl everyday. I had TERRIBLE reactions to tecfidera, I can imagine why so many people are switching to other medicines.
Tamara Sellman
Almost 5 years on Tec, still in remission. I’m pretty happy with my therapy. I’m not alone. One study of 600 in Sweden with no clear reasons to explain changes in usage (except guessing?) is not legit enough to report on in an article, frankly ?
James Lucas
Been on it for 4-5 years now and personally paired it with medical marijuana to curb the stomach problems and add CBD to the mix. All of my lesions have subsided since then, and the only problem I have is the flushing. I highly recommend eating with this and making sure to keep them 12 hours apart as best you can.
AJ
I’ve been on Tec for about a year now. Similar to others, if i take it on an empty stomach it can be upsetting but the worst of my symptoms is flushing. That usually will go away within 15-20 min. Best of luck to you all on your journey. You are not alone.
Heather
Hello,
I’ve been on Tec for about a year and a half now. The flushing I can cope with, but for some reason it’s happening nearly every time now and I’m starting to feel background ‘sicky’. Very odd after all this time and I’m wondering if the meds are being ‘tweaked’ with. Not that we would be told I guess, as we are the guinea pigs. My hair is also thinning, but that could be an age thing.
Sherri
I’ve been on Tecfidera for about a year and a half now. I did have flushing initially, but that went away within a few weeks. I have no trouble tolerating it, no tummy troubles or anything, even when I take it on an empty stomach. So far, no new relapses.
Nick
How long did it take for all tummy issues to pass. Is it also certain u will experience some pains
Dawn
I have been on Tec for just over a year and get the flushing sometimes too. I feel like it comes on not when I take the med, but later when I have a snack or even just drink water. Also, I have noticed the hair thinning. and now it's to the point where other people are noticing it too :(
Micheal Griffith
That's what I've noticed taking this medication for 7 months. Taking it on an empty stomach seems better than when I actually eat, then the flushing gets really intense. It is funny because the side effects pamphlet says if you get flushing Try eating with the medication.
Christina
I only started this drug two weeks ago and apart from a little flushing the very first day I took it I'd had no problem until last night but now I have unbearable abdominal pain and nausea and anything I've taken to alleviate these symptoms has had no effect. The tecfidera helpline won't be open again until Tues because of the Easter bank holiday and GPs seem to know nothing about it so I don't know what to do now because I don't feel I can continue like this.
Jonathan Brookman
How else can I cope with stomach pain? It wakes me up in the middle of the night and I can’t sit up so of course I can’t work. This is only week 2 of tecfidera.
Rian
This is exactly what's happening with me now! Did you continue to take it? I'm unable to go to work the pain is so bad!
Stewart
I am just coming off Tec however I never had stomach pain if I had the pill with a teaspoon of peanut butter. No peanut butter not so good unless very fatty food. Luck.
Christina
This is exact same thing happened to me... did it ever get better?
neha roy
Hi
I've been on Tecfidera a little over a year. No side effects and my Neuro says I'm in remission. But my symptoms do appear again as the weather changes. I've noticed when the humidity and heat is up that's when my leg gets heavy and I limp. But other than this no other symptoms.
Carla
I have been on Tec for about a month now and the diarrhea and vomiting and lack of sleep I feel like I'm better off without it so I'm going to to see what the next option for me is I'm a new m.s.er but I have had it since I was a teenager and the Doctors just figured it out now that I'm in my 50s what to do
Ardah Holcomb
I began Tec three weeks ago. After my third increase in the medication dosage I started having insomnia, nausea, vomiting, horrible headaches, vision problems, memory problems.
This is my 5th MS drug I have had to stop. First it was Avonex, betaseron, Copaxone, Aubagio and now trying Tec, which is also troublesome. I am about to give up. I would rather live out the rest of my life without the horrible side effects, so I can live my life. (I am 66 years old)
Sharon Clifford
I’m right there with you. I’ve been on other drugs...Avonex, Aubagio, took a 6 year sabbatical from dmt’s. Was sick and tired of being sick and tired. Today was my second day on Tecfidera....and my last I’m sure. If “flushing” is from head to toe bright red solid welts that sting intensely lasting beyond 12 hours then I can do without it. There has to be other DMTs with less intense side affects.
Michelle
Hi I took Tec for 6 days , a total nightmare. Side effects I'm still encountering are vision issues in my right eye. In 6 days I kept contacting Tec explaining what was going on and they were sympathetic but didn't recommend to keep taking or not but were grateful for the info. Unlike the MS clinic I was calling almost everyday and all the tell me is to keep pushing thru it that it would get better I was experencinng not being balanced in my walking by 4th day horrific pains in my right eye, lips swelling and body, horrid pains in my head where I don't obtain, lesions and the pain in my right eye circled my right eye, went around my right eye then down my right check. My vision in my right eye was so limited by day 6 I thought I was going blind. Until I got to my Drs office for a steroid shot that helped some but benadryl brought me back immediately. Until I,landed in er a week later and eye Drs with steroids for a week yet no correspondence when u stopped after day 6 of saying somethings not right. I just took a benadryl an hour ago never taken thus much in my life and contacted an attorney. Not playing around with my vision. Irrate with ms doctor will,see a new one in 2 months? all symptoms go away but am requesting another MRI bc I feel it also gave me more lesions.
Natasha
I’ve been on Tec for a few months and can’t get my limo to go away. I can barely walk a mile at a time whereas I used to be able to walk 5+ miles. I’m miserable and scared, and all my doctor wants to do is prescribe me more Rx. I requested oral steroids as the IV steroids are way too expensive for my Obamacare insurance! Help.
Cody
Just stopped my Tec today after 3 weeks.
Only had a couple of flushes the first week. 1 big flush that hit like a lava wave was hot for an hr had to leave work during the 2nd week 3rd week no flushing or any other side effects till this last Friday. No flushing but got aches within an hour of my morning dose. Made it through the day and took my evening dose an hour later I had a fever and chills. My gut was I knots,later that night I had watery diarrhea and puking. Next dose Saturday morning braved it. Same thing couple hours later sick as a dog. Fought through the day trying to sleep. Sat evening dose came and I took it. Repeat of the morning. Now its Sunday evening still having minor gut aches and sweating profusly.ive are twice today kept it down but pissed out my ass with 1/2 hour of each meal. I'm going call my Nuero tomarrow and hope he understands why I refuse to take anymore Tecfidera.
I'm glad its helped lots of you! I pray for the rest of us to find something a little more tolerable.
Joan
This is my third full-dosage week of Tecfidera. First full-dosage week was fine; second started off bad and has only gotten worse this third week. Debilitating stomach pain and diarreha has turned into horrible nausea and vomiting throughout the day and night this week. I'm unable to work effectively at all. I would love to try to tough it out, but I just don't see it getting any better. I've been on Avonex and Copaxone prior to this; my serum level for JC virus was too high to consider Tysabri infusions.
B
Hi Guys,
Anyone suffering with the tummy problems, try push through it, I know its hard as it can be so painful and embarrassing. I got to a point where I just didnt want to eat as I knew I would be in horrible pain. My tummy issues started after 2 weeks of taking the tablets but eventually after 3-4 weeks it started getting better. I am on the tablet 3 months now and have no tummy issues at all just some hot flushes sometimes but I know everyone is different. Just want to let you know it hopefully it will pass for you too!
Eilish
I've been on Tecfidera for over 6 months now. It's not great I get flushing randomly and they can be head to toe and make me soo sick (not pleasant where in a different city from home) and definitely get a lot of acid if I don't have enough fat. I've had atleast two smaller relapses while on it lasting 2-3weeks at a time (in comparison to 6months at a time, I'll take it). My body seems to be handling it with my leukocytes sitting at a nice 1.2 (I was soo soo happy when the nurse told me. She's didn't quite understand why I was happy til I explained it was at 0.8 a month after Gilenya and kept dropping, so to have it stable is great.)
I have a sensitive liver where Gilenya completely out it out of whack but somehow my body is handling.
Sadly my use of over the counter medication to cope with the flushing , mild stomach issues etc is higher than I'd like but needs must.
Do I see myself in it long term. I don't know. I'm one to not want to rock the boat so I'll probably stay on it longer than I should because I'm used to it. And cause my neuro/nurse are pretty guff if I'm honest.