Tecfidera® (Dimethyl fumarate)

The active ingredient in Tecfidera® is dimethyl fumerate, which works to reduce MS relapses and slow the progression of RRMS. Tecfidera reduces the inflammation in the brain caused by MS and helps to protect the cells that form the myelin against attacks which may damage it.

It is thought that Tecfidera does this by turning on an antioxidant mechanism in the body which deactivates and removes free radicals (generated by inflamation) that are damaging the myelin.

TECFIDERA cannot repair damage that has already been caused by MS. When you start Tecfidera you might not notice an improvement, but Tecfidera may still be working to help prevent your MS from becoming worse.

Tecfidera is proven to reinforce that early treatment with this drug can improve long-term clinical outcomes in patients. Studies have shown that half of newly diagnosed patients treated with Tecfidera did not relapse or progress for 6 years.

How is Tecfidera administered?

Tecfidera comes in a capsule that is taken twice a day; one capsule in the morning and the second (capsule) in the evening.
The starting dose is one 120mg capsule, twice a day for 7 days. After the first 7 days a regular dose of one 240mg capsule is taken twice a day. It is important to take as prescribed by your doctor, to take whole and with a glass of water. In no circumstances should you crush, divide or dissolve the capsule or its contents.

Side Effects

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Side effects can include:

• reddening of the face or body feeling warm, hot, burning or itchy (flushing)
• gastrointestinal disorder (nausea, vomiting, diarrhoea, indigestion, stomach pain/cramps)
• inflammation of the lining of the intestines (gastroenteritis)
• burning sensation
• itchy skin (pruritus)
• rash
• pink or red blotches on the skin (erythema)

The above list includes the more common side effects of your medicine. If any of these persist or worsen, talk to your doctor as they may also be due to an infection or allergic reaction.

Eligibility

Special Authority must be approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC) before funding is approved. Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria.

For details of the current criteria and how to apply for funded treatment see Disease Modifying Treatment Special Authority Criteria

Feedback from other patients

It is often helpful to review how other people with MS have liked or tolerated a treatments and the benefits and side effects they have experienced.

Patients Like Me – Tecfidera

Clinical Trials

Three Phase 3 trials (DEFINE, CONFRIM, and ENDORSE) show Tecfidera’s efficacy in reducing relapse and disability measures in newly diagnosed relapsing remitting patients.

• The study enrolled participants who were newly diagnosed with MS within 1 year of enrolling in DEFINE or CONFIRM, patients who are treatment-naïve, or patients who only received treatment with corticosteroids alone.
• Researchers found that patients who received Tecfidera at the beginning of DEFINE and CONFIRM maintained positive effects opposed to patients that switched to Tecfidera treatment in ENDORSE after taking placebo for 2 years in the other studies (56.3% versus 50.6%).
• According to the study, Tecfidera was associated with lower annualised relapse rate of MS relapse in relation to other MS treatments, such as glatiramer acetate, interferon β, teriflunomide, and fingolimod.
• Study authors note that Tecfidera and fingolimod had similar results.
• After 1 year, the unadjusted ARR rates from the baseline were: Tecfidera (-0.14; p<0.0001); interferon β (-0.03); glatiramer acetate (+0.03); teriflunomide (-0.04); fingolimod (-0.12; p=0.0016).
• To understand the safety profile of Tecfidera, data presented at American Academy of Neurology explored the treatment’s effects on lymphocyte profiles. The data reinforces the importance of absolute lymphocyte counts (ALC) monitoring and supports the long-term safety profile of Tecfidera, the study concluded.

DEFINE Trial
This was a 2-year, randomized, multi-centre, double-blind, placebo-controlled, dose-comparison phase 3 clinical trial. More than 1200 patients with remitting multiple sclerosis (RRMS) were evaluated. The main purpose of this study was to determine whether Tecfidera was effective in reducing relapses in patients after 2 years.

CONFIRM Trial
This was a 2-year, randomized, multi-centre, placebo-controlled, double-blind, dose-comparison phase 3 clinical trial. More than 1400 patients with RRMS were studied.  The main purpose of this study was to determine whether Tecfidera was effective in reducing replaces in patients after two years.

ENDORSE Trial
This is an ongoing dose-blinded study that enrolled 1738 patients who completed either the DEFINE or CONFIRM studies.

• Patients who received 2 years of Tecfidera in either of the aforementioned studies continued the same dose. Patients who previously received a placebo were randomized 1:1.
• These patients will be followed for up to 8 years in order to evaluate the long-term safety of TECFIDERA.

Read more here

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC)

• The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.
• The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.
• Estimated completion date April 2019

Read more here

What to do about a bad reaction to medication

Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).

For instructions and further information https://nzphvc.otago.ac.nz/reporting/

More information

Biogen press release on safety, efficacy and trial results – April 2016