Twice Daily Dosing and Side Effects Top Reasons Patients Seen to Stop Tecfidera in Small Study

Twice Daily Dosing and Side Effects Top Reasons Patients Seen to Stop Tecfidera in Small Study

A twice-daily dosing schedule and side effects like nausea and flushing are key reasons why more than 10% of multiple sclerosis (MS) patients followed for a year stopped using Tecfidera (dimethyl fumarate) as prescribed, a single-site study reports.

Adherence to treatment is key to patients’ health, and doctors should not overlook these barriers and counsel patients before starting a treatment, its researchers said.

The study “Assessing Barriers to Adherence with the Use of Dimethyl Fumarate in Multiple Sclerosis” was published in the journal Clinical Drug Investigation.

Complying with prescribed medication is crucial in reducing relapses and neurodegeneration in MS. Thus, treatment adherence rates are important to consider when patients start on a disease-modifying therapy (DMT).

Poor adherence relates to worse clinical outcomes, including more frequent and severe relapses. People can have many reasons for stopping a treatment. Side effects weigh substantially, as do social and economic factors, healthcare team support, and issues relevant to the individual patient.

Much research has gone into barriers in adherence to injectable DMTs (like interferons), but less is known about compliance with oral medications.

Researchers in the U.S. set out to define the patient-related factors that affect adherence to Tecfidera (marketed by Biogen), and understand how patients’ perceptions of this medication influenced their compliance.

They monitored Tecfidera compliance in 25 MS patients (mean age of 41.1 at study’s start) over 52 weeks, during routine clinical visits to the department of neurology of Morsani College of Medicine, University of South Florida.

Of these people, 26% had never before been treated with a DMT. Most were switching from an injectable medication — glatiramer acetate (brand names Copaxone, Glatopa, generics also available; 28%), interferon-beta-1a (brand names, Avonex, Rebif; 20%), or interferon-beta-1b (brand names Betaseron, Extavia; 3%).

Adherence was determined by looking at how many times a patient opened the pill bottle (MEMS cap compliance), and the number of pills taken by the patient (pill count compliance).

An electronic monitoring system was used, consisting of a small microcircuit inserted into the drug packages, which recorded each time bottles were opened. To determine PCC, pills taken by the patient were counted at each visit (pills not brought back in the bottle).

Results showed that at the final follow-up visit (at week 52), the rate of pill count compliance was 88.5%, and MEMS cap compliance was 83.5%.

Treatment compliance was found to be significantly related to the patient’s overall perception of treatment convenience, side effects and effectiveness, according to patient responses to a specific survey.

The most common side effects of Tecfidera treatment were nausea (23%) and flushing (redness, itching or rash; 66%), with most of such reactions occurring over the first four weeks of treatment.

Patients who considered Tecfidera easy to take, with side effects that were not bothersome and didn’t interfere with their overall satisfaction — or trouble their physical and mental health — were more likely to use it as prescribed and be compliant.

Good compliance was also seen in those who felt satisfied with Tecfidera’s effectiveness. Regarding this, researchers noted that the perception of treatment effectiveness depended on a patient’s feelings of depression and fatigue. Those more affected by these symptoms were more likely to feel that Tecfidera was not helping them.

Patients with fewer symptoms interfering with their quality of life were also more compliant. Factors weighing on life quality included memory problems, difficulty concentrating, vision changes, dysesthesias, how well a person felt understood and encouraged by family and friends, and/or satisfaction with partners and their sex life.

Of all the identified patient-related barriers to compliance with Tecfidera prescriptions, researchers highlighted two as key: adverse events and the medication’s twice-daily dosage scheme. Among all oral DMTs, Tecfidera is the only one that needs to be taken twice each day.

“Adherence rates are an important factor to be considered when starting patients on DMT. DMF [Tecfidera] creates its own barriers to adherence with our study highlighting some, including twice-daily dosing and AEs [adverse events] experienced following treatment initiation,” the researchers wrote.

Healthcare providers play an important role in compliance, they added, specifically in the relationship they establish with patients, and how well they make them feel understood and respected.

“Healthcare providers should be aware of these [adherence] barriers prior to treatment initiation, and counsel patients appropriately,” the team concluded.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
Total Posts: 1,053
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
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9 comments

  1. Pik says:

    Diagnosed MS 3/13, Tecfidera was new on market. Doctor put me on it. Flushing,nausea,diarrhea were very horrible. 240mg twice daily was to much. After 4 months,stopped taking it. VUMERITY DMT is in trial phase,to have lower side effects. They’re calling it Tecfidera Light.🤭

  2. Landon Coleman says:

    I have been using Tecfidera since it was FDA approved,2013. I still have the flushing regardless of whether I take it before or after eating or without food. My other symptoms are directly related to my MS. I used Rebif prior. The control of progression and relaps greatly outweigh the side effects of Tecfidera. MS since 1980, no new lesions since starting Tecfidera, however, fatigue is still there, MS symptom, not DMT. I schedule my activities and rest when needed.
    I realize all MS Patients have differing symptamatic effects.

    Landon Coleman

  3. Charles Dick says:

    I think that what most people want is something you take once and then no longer have the disease. The ideal is a cure.

  4. Anonymous says:

    Stop putting dollars toward studying why patients are not compliant with the existing meds. Put that money toward developing effective meds that do not have awful side effects.

    Drug companies are always trying to defend/explain their products’ hideous problems. We need their help, but create better products. It is common sense that patients are not compliant with the assorted make-yourself-feel-even-more-ill drugs on the market.

  5. ellen niit says:

    I tried the 120 mg to start. First morning dose 240 mg too much for my body. 4 hrs after I felt so hot I headed to shower. I looked at myself I had whole body flushing head to toe. It looked like I had a terrible sunburn, legs felt like they had added weights, diaherra ,not too bad nausea. Called Biogen, talked to pharmacist at Acaria. Cut back to 120 mg x2. Not as bad but legs feel so heavy. Went three months from Copaxone to Tecfidera and I felt awesome ! Still deciding if it’s worth the elephant legs !!

  6. Kim Gary says:

    I was on the lowest dose of tecfidera and the first dosed landed me in the ER this drug is horrible with the nausea flushing etc I filed all the rules before taking it and never again. Also realizing it’s a mild chemo drug.

  7. Concerned Caregiver says:

    These side effects, no matter how mild or severe sound wretched. Let’s help the body heal, not hurt the body. With all the physical challenges that ms patients (like my wife) have to endure, even one more discomfort, or ailment is one too many. Let’s do better please. Wasn’t this drug first an upholstery cleaner? Maybe I’m thinking of something else. Not related to this drug, but for example say a DMT has shown liver failure to 2 out of 1,000 patients. Well, that’s two too many. These are lives we are dealing with, not statistics. Heal the body. Do no harm. NONE!

    • Anonymous says:

      Totally agree. Not blaming doctors for the awful meds. Still, it is useless to ask MS patients if they are “under stress” when the recommended treatments (lifelong) are very, very stressful due to risks and horrible side effects.

      Some of the meds should never have been approved in the first place. Too little is known about them and too much is asked of patients in terms of making themselves feel even sicker. Meanwhile, almost nothing is asked of pharma companies; they should be put on notice to either solve/reduce side effects or have their meds pulled.

  8. Terry says:

    I was on Tec for several years and stopped. Not due to flushing and gastronomic problems as those disappeared after the first month. But my hair started getting very thin, then it started falling out heavily. Rather than stopping, as it wasn’t identified as a side effect, I started taking Hair, Skin and Nails Vitamins. Made my nails grow like crazy, but did nothing for my hair issue. Stopped the Tec and four months later, my hair improved. Tried Tec a year later, and hair started thinning out again within three months. Stopped again and haven’t been on anything since. Haven’t had any new lesions in years, but still going downhill. At age 63, don’t know if DMD’s are beneficial to my age group. Nothing was available when I was diagnosed in 1988 and Neuro’s didn’t even start me until 1998. I would highly recommend some type of DMD for newly diagnosed as it may very well keep you from being where I am today. Still mobile, but it’s a struggle. Good luck as there is something that will work best for each of you.

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