Teriflunomide
Teriflunomide is a potential oral treatment in development for relapsing remitting MS or secondary progressive MS.
Who is it for? People with relapsing remitting or secondary progressive MS
How is it taken? A tablet taken by mouth once per day
- How does it work?
- Latest research
- Side effects
- How does it compare to current therapies?
- Further work
- When will it be available?
How does it work?
Teriflunomide affects the immune system by blocking the action of a specific set of immune cells called T-cells.
T-cells are thought to be responsible for causing damage to the brain and spinal cord in people with MS.
Other cells of the immune system are thought to be left intact, affording people with MS some immune protection against infections.
Latest research
Phase 3 trial results were reported at an academic meeting in 2010.
The two year trial involved two doses of teriflunomide (7mg and 14mg). The trial involved 1088 people with relapsing remitting MS.
- Teriflunomide was associated with reduced lesion volume as measured by an MRI brain scan. The higher dose (14mg) was associated with a 67 per cent reduction in lesion volume and the lower dose (7mg) was associated with a 39 per cent reduction in lesion volume.
- Both doses of teriflunomide were associated with around a 30 per cent reduction in annual relapse rate.
- The higher dose of teriflunomide (14mg) was associated with a 30 per cent reduction in sustained disability progression over a 12 week period.
What are the side effects?
Overall teriflunomide was well tolerated with no serious side effects reported. Side effects included: nausea, headaches, diarrhoea, and hair thinning/loss. There was no increased risk of infection in people treated with teriflunomide.
A follow-up study of a phase 2 clinical trial of teriflunomide has demonstrated that teriflunomide was relatively safe over an eight year period.
How does it compare with current therapies?
Teriflunomide was compared with a placebo (dummy treatment) in these trials and therefore it is not possible to compare its effectiveness with available therapies.
Further work
There are currently nine trials evaluating the effectiveness and safety of teriflunomide in MS.
- A phase III study involving 780 people to test the effect that teriflunomide has on whether individuals experiencing clinical isolated syndrome (the first symptoms of MS) go on to develop MS. The study is currently recruiting and due to complete in October 2012 (clinicaltrials.gov identifier: NCT00622700).
- A phase III study involving 300 people testing whether teriflunomide plus betainterferon- 1a is more effective than beta-interferon-1a alone in people with relapsing remitting MS. The study is currently recruiting and due to complete in October 2011 (clinicaltrials.gov identifier: NCT00883337).
- A phase III study involving 1110 people with relapsing remitting MS testing the effectiveness of teriflunomide against a placebo treatment at reducing relapses. The study is due to complete in September 2011 (clinicaltrials.gov identifier: NCT00751881).
- A phase II study involving 180 people to test the safety and effectiveness of teriflunomide on people with MS that have relapses. This study is ongoing and due to complete in November 2011 (clinicaltrials.gov identifier: NCT00228163).
- A phase II study involving 120 people testing teriflunomide plus copaxone with copaxone alone in people with MS. The study was due to complete in June 2009 but has not reported back yet (clinicaltrials.gov identifier: NCT00475865)
- A phase II study involving 120 people testing teriflunomide plus beta-interferon with beta-interferon alone in people with MS. The study was due to complete in February 2009 but has not reported back yet (clinicaltrials.gov identifier: NCT00489489)
- A phase II study involving 240 people comparing teriflunomide plus beta-interferon or copaxone with a placebo treatment in people with MS. The trial completed in April 2010 but has not reported back yet (clinicaltrials.gov identifier: NCT00811395)
- A phase III study involving 1080 people comparing the long-term safety and effectiveness of two doses of teriflunomide against a placebo treatment. The study is enrolling by invitation only and is due to complete in March 2011 (clinicaltrials.gov identifier: NCT00803049)
When will it be available?
This will rely on a successful licence application. The company that owns teriflunomide has not indicated when they are planning on applying for a licence. It is not likely to be available for several years.
