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Teriflunomide

Teriflunomide is a experiemental new drug treatment for people with relapsing remitting multiple sclerosis (MS) that is taken by mouth.

Other names: HMR1726, A771726
In development for: Relapsing remitting MS
Status: Phase III
Last updated: July 2009

How does it work?

Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. In addition, it appears to have other immunomodulatory and anti-inflammatory actions.

Teriflunomide is closely related to leflunomide which is used to treat rheumatoid arthritis, an autoimmune condition.

How is it given?

Teriflunomide is given orally as tablets.

Clinical studies

In a phase II study involving 179 people over a period of 36 weeks, two different doses of teriflunomide were compared to placebo in people with relapsing remitting MS or with secondary progressive MS with relapses. Both doses were associated with reduced numbers of active MRI lesions and the higher dose was associated with a significantly smaller increase in disability compared to placebo.

Further clinical trials

A number of phase II and phase III studies are currently underway or recruiting. Phase III studies are evaluating the effectiveness of teriflunomide in relapsing remitting MS compared to placebo or interferon beta-1a and in delaying conversion from a first clinical symptom suggestive of MS to clinically definite MS. In addition, two phase II pilot studies are assessing the combination of teriflunomide and one of the established disease modifying treatment.

  • TEMSO - Study of teriflunomide in reducing the frequency of relapses and accumulation of disability in patients wth multiple sclerosis

    • This phase III, two year study, which is currently underway, is comparing two doses of teriflunomide with placebo in 1080 people with relapsing remitting MS or secondary progressive MS with relapses. Further details of this study.

  • Long term safety and efficacy study of teriflunomide 7 mg or 14 mg in patients with relapsing-remitting multiple sclerosis

    • Those people completing the TEMSO study will be given the opportunity to continue treatment in this extension study. Further details of this study.

  • TOWER - An efficacy study of teriflunomide in patients with relapsing multiple sclerosis

    • A second phase III study comparing two doses of teriflunomide and placebo for 48 weeks in 1110 people with relapsing remitting MS. The main measure of this study will be the number of relapses per year. Further details of this study.

  • TENERE - a study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis

    • This phase III study is comparing two doses of teriflunomide with interferon beta 1a in 300 people over a treatment period of 48 weeks. The main measure of the study is the time take to treatment failure, which could be the first occurence of a relapse or withdrawal from the study. Further details of this study.

  • TOPIC - Phase III study with teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis

    • This study is evaluating teriflunomide in people with a first clinical episode suggestive of MS. The main measure of the study will be the time taken develop clinically definite MS. The study is comparing two doses and placebo in 780 people with CIS (clinically isolated syndrome). Further details of this study. More details of the study, including UK study centres are available fron the TOPIC study website.

  • Pilot study of teriflunomide as adjunctive therapy to glatiramer acetate in subjects with multiple sclerosis

    • A phase II study in 120 people already taking glatiramer acetate (Copaxone). Participants will take one of two doses of teriflunomide or placebo for 24 weeks. The main aim of this study is to assess how well the additional trteatment with teriflunomide is tolerated. Further details of this study.

  • Pilot study of teriflunomide as adjunctive therapy to interferon-beta in subjects with multiple sclerosis

    • Similar to the study described above, this is a phase II study in 120 people already taking one of the interferon betas. Participants will take one of two doses of teriflunomide or placebo for 24 weeks. The main aim of this study is to assess how well the additional trteatment with teriflunomide is tolerated. Further details of this study.

Side effects and contraindications

Treatment was well tolerated; numbers of adverse events and serious adverse events were similar in all treatment groups. Headaches and nausea were both reported.

References

O'Connor PW et al.
A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses.
Neurology 2006;66(6):894-900.
Read abstract

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