- Oral medication taken daily.
- This drug is an immunomodulator that affects both T and B-cell proliferation. It inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. It also appears to inhibit nerve degeneration by reducing the production of free radicals by macrophages and astrocytes. Unlike similar drugs, it is not thought to affect other immune functions, possibly providing patients with a decreased risk of infections and other complications linked to chemotherapy-like drugs.
- A Phase II trial of RRMS evaluated two dose levels versus placebo. The treated groups had significantly fewer enhancing lesions and a lower relapse rate; fewer patients in the high-dose group experienced an increase in disability versus placebo, and there was a trend toward more relapse-free patients. Treatment was well tolerated. Side respiratory, but these were not serious.
- The TEMSO trial for RRMS is comparing 7 and 14 mg of teriflunomide in 1,080 individuals. The primary endpoint is relapse rate; secondary measures include time to progression of disability, total disease burden on MRI, and subject-reported fatigue. The study was completed in July 2010; results are not yet available.
- The TOWER efficacy study of 1,110 individuals with RRMS is now enrolling and is scheduled for completion in September 2011. It will test 7 and 14 mg doses versus placebo. Its primary endpoint is relapse rate; the secondary endpoint is time to disability progression.
- The ongoing TOPIC study of 780 individuals with CIS, also compares 7 and 14 mg active drug versus placebo. The study began in February 2008 and its primary endpoint is the time of conversion to clinically-definite MS. Secondary endpoints include burden of disease and other MRI variables, relapse rate, the proportion of disability-free patients, and the drug's safety and tolerability.
- Phase II combination studies of teriflunomide added to interferon and Copaxone in clinically stable patients have been completed. Both studies evaluated tolerability and safety, the number of gadolinium-enhancing lesions, and burden of disease on MRI. Combined treatment with teriflunomide appears to be superior to interferon alone in reducing lesion load. No significant difference was seen in relapse rate, although a trend was found toward improvement in the combination group. The combination with Copaxone, although primarily a safety study, showed a reduction in the number and size of lesions as seen on an MRI.