AE, O’Connor P, Wolinsky JS, Confavreux C, Kappos L, Olsson TP,
Truffinet P, Wang L, D’Castro L, Comi G, Freedman MS; for the
Teriflunomide Multiple Sclerosis Trial Group.Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012 Jun 21. [Epub ahead of print]
Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled
phase III study, demonstrated that teriflunomide significantly reduced
annualized relapse rate (ARR), disease progression and magnetic
resonance imaging (MRI) activity, with a favorable safety profile in
relapsing multiple sclerosis
effects of teriflunomide on ARR and disability progression in
placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks.
Subgroup analyses were performed for ARR and disability progression by
baseline demographics (gender, race, age), disease characteristics
(Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis
(MS) subtype), MRI parameters (gadolinium-enhancing lesions, total
lesion volume) and prior use of MS drugs. A generalized estimating
equation method and Cox regression model were used to assess consistency
of the treatment effect across subgroups, utilizing a
treatment-by-subgroup interaction test for each factor
consistent across subgroups in favor of teriflunomide, with no
treatment-by-subgroup interaction test reaching statistical
demonstrated consistently across subgroups in TEMSO.
Although there was no difference in relapse rate between placebo and secondary progressive MSers this would be expected as the number of relapses in SPMS is reduced. However there was some influence in the rate of progression in this group.
This drug is being positioned to compete against beta interferons and glaterimer acetate as it as about as safe and effective as the compounds mentioned but has the advantage of been oral.