Epub: Freedman et al. Teriflunomide added to interferon-β in relapsing multiple sclerosis: A randomized phase II trial. Neurology. 2012 May.
OBJECTIVE: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-β (IFNβ) in MSers with relapsing forms of multiple sclerosis (RMS).
METHODS: A total of 118 MSers with RMS were randomly assigned 1:1:1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 MSers entered the 24-week extension. The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate.
RESULTS: Teriflunomide was well tolerated with a low and similar incidence of treatment-emergent adverse events (TEAEs) across the 3 groups; TEAEs led to treatment discontinuation of 4.9%, 8.1%, and 7.9% of MSers in the placebo, 7-mg, and 14-mg groups, respectively. The number of gadolinium-enhancing T1 (T1-Gd) lesions was reduced in both teriflunomide groups, with relative risk reductions (RRRs) of 84.6% (p = 0.0005) and 82.8% (p < 0.0001) for 7 and 14 mg, respectively, compared with IFNβ alone at 48 weeks. T1-Gd lesion volume was also reduced in the 7-mg group (RRR 72.1%, p = 0.1104) and 14-mg group (RRR 70.6%, p = 0.0154). A trend toward dose-dependent reduction in annualized relapse rate was also noted (RRRs 32.6% [p = 0.4355] and 57.9% [p = 0.1005] for 7 and 14 mg, respectively).
CONCLUSION: Teriflunomide as add-on therapy to IFNβ had acceptable safety and tolerability and reduced MRI disease activity compared with IFNβ alone.
Classification of evidence: This study provides Class II evidence that teriflunomide, 7 and 14 mg, added to IFNβ, is safe. The T1-Gd lesion burden was significantly reduced with both teriflunomide doses.
"Teriflunomide is one of the emerging oral therapies for MS and is in the same efficacy zone as IFN-beta and glatiramer acetate. Will the economics add-up for combination therapy? Will healthcare providers be prepared to pay for teriflunomide and a first-line injectable? I doubt NICE will give the combination therapy a green light."
Other posts on this blog on teriflunomide:
Multiple Sclerosis Research: Drug from Licence to the MSer, 24 Apr 2012; Then there is the pricing where are they going to place terifluomide next to beta intereferon and glaterimer acetate. Price above because of convenience (pill v injections) or price below and take the business from beta ...
BG12 - the last of the 5 oral MS therapies in phase 3 is positive, 18 Apr 2011; BG12 - the last of the 5 oral MS therapies in phase 3 is positive. The Phase 3 results of another oral agent BG-12 (dimethyl fumarate) in RRMS were reported last week. The top-line results show that 240 mg of BG-12, ...
Multiple Sclerosis Research: New survey: environmental impact of ..., 11 Sep 2011; With the emergence of oral therapies the environmental impact of injectables may be an issue worth considering. To explore this we would appreciate it of you could vote on the latest survey." Policy: potential environmental ...
Labels: Beta Interferon, Teriflunomide, Trial.