A Cochrane review [Abstract] 1 included 5 studies with a total of 3231 subjects with relapsing remitting multiple sclerosis (MS). The studies evaluated the efficacy and safety of teriflunomide 7 mg and 14 mg, alone or with add-on IFNβ, versus placebo or IFNβ-1a for adults with relapsing forms of MS and an entry Expanded Disability Status Scale score of less than 5.5.Two studies evaluated the benefit and the safety of teriflunomide as monotherapy vs. placebo over a period of one year (n=1169) or two years (n=1088). Three studies had a high dropout rate (29.8%, 36.4% and 20.1%). Compared to placebo, teriflunomide at a dose of 14 mg/day (a licensed dose) reduced the number of patients with at least one relapse over one year (RR 0.60, 95% CI 0.48 to 0.75; one study, n=761) or two years (RR 0.80, 95% CI 0.69 to 0.93; one study, n=722). It also reduced the number of patients with disability progression over one year (RR 0.55, 95% CI 0.36 to 0.84; one study, n=761) or two years (RR 0.74, 95% CI 0.56 to 0.96; one study, n=722). Teriflunomide also reduced the annualized relapse rate and the number of gadolinium-enhancing T1-weighted lesions over two years.When compared to IFNβ-1a, teriflunomide had a similar efficacy to IFNβ-1a in reducing the proportion of patients with at least one relapse over one year (RR 1.52, 95% CI 0.87 to 2.67; n=215).The most common adverse events associated with teriflunomide were diarrhoea, nausea, hair thinning, elevated alanine aminotransferase, neutropenia and lymphopenia. These adverse events had dose-related effects and rarely led to treatment discontinuation.
Comment: The quality of the evidence is downgraded by study quality (high drop-out rate).
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