Teriflunomide for multiple sclerosis.

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Multiple sclerosis (MS) is a chronic, immune-mediated central nervous system disease causing neurological disability.
• Disease-modifying therapies (DMTs) aim to prevent relapses and disability progression in MS.
• Teriflunomide, a pyrimidine synthesis inhibitor, is approved for relapsing-remitting MS (RRMS).

Purpose of the Study:

• To assess the effectiveness and safety of teriflunomide versus placebo or other DMTs in MS.
• To evaluate teriflunomide as monotherapy or combination therapy for modifying MS disease course.

Main Methods:

• Searched Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group Specialised Trials Register and other sources up to September 2015.
• Included randomized, controlled, parallel-group trials of teriflunomide (monotherapy or combination) versus placebo or other DMTs.
• Assessed trial quality and extracted data independently; contacted investigators for additional information.

Main Results:

• Five studies (3231 participants) evaluated teriflunomide (7 mg/14 mg) versus placebo or interferon beta-1a (IFNβ-1a).
• Teriflunomide monotherapy (7 mg/14 mg) reduced relapses compared to placebo over one and two years (low to very low quality evidence).
• 14 mg teriflunomide reduced disability progression over one and two years (very low quality evidence); common adverse events included diarrhea, nausea, hair thinning, and elevated liver enzymes.

Conclusions:

• Low to very low quality evidence suggests teriflunomide monotherapy reduces relapses and, at 14 mg, may reduce disability progression in MS.
• Data quality was insufficient to evaluate teriflunomide versus IFNβ-1a or in combination therapy.
• Further high-quality, long-term studies are needed to assess teriflunomide's comparative benefits and safety against other DMTs.