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Teriflunomide (Aubagio°) is or will soon be on the market in several countries

Teriflunomide (Aubagio°) in the treatment of relapsing-remitting multiple sclerosis is reviewed in the March 2015 issue of Prescrire International  The article includes a round-up of reviews from independent editorial teams in various countries.

Vu d'ailleurs
The following conclusions were reached by teams that have examined the available clinical data on teriflunomide (Aubagio°), including bulletins independent of the pharmaceutical industry.
  • Arznei-Telegram (Germany) considers that there is no evidence that teriflunomide provides any advantages over interferon beta-1a, or even that the two drugs are equivalent. Nor can an effect on the progression of disability be guaranteed. Its adverse effects profile includes hepatic disorders, infections, blood pressure elevation, peripheral neuropathy, skin reactions and hypersensitivity, corresponding to those of leflunomide, the parent drug. There is no indication for teriflunomide (1).
  • Pharma-Selecta (Netherlands) considers that the advantages of teriflunomide are oral administration, use as single-agent therapy, and previous experience with this drug in rheumatoid arthritis. However, its adverse effects and the many precautions for use are drawbacks. There is limited experience with this drug in multiple sclerosis (2).
  • Drug and Therapeutics Bulletin (UK) considers that one trial showed no statistically significant difference between teriflunomide and interferon beta-1a in terms of treatment failure, as defined by an endpoint combining relapse and permanent treatment discontinuation. However, this trial was not designed to compare the efficacy of the two drugs. There are no published trials directly comparing teriflunomide with other medications, so it is difficult to determine its exact place in the therapeutic panoply (3).
  • Australian Prescriber (Australia) considers that some adverse effects of teriflunomide are predictable because of its relationship with leflunomide. Most patients experience adverse effects, but not all benefit from this treatment. In one trial, approximately 54% to 57% of patients on teriflunomide did not relapse, compared with 46% of patients in the placebo group. This drug has only a modest effect on relapses, which has to be weighed against the need for regular monitoring and the risk of serious adverse effects (4).
  • Prescrire (France) considers that there is no evidence that teriflunomide delays the progression of disability in patients with relapsing-remitting multiple sclerosis. A comparative trial showed no superiority of teriflunomide over interferon beta-1a in terms of relapse. Teriflunomide has a burdensome adverse effect profile. Its teratogenicity and long half-life of elimination complicate treatment. In practice, in the absence of a better alternative, interferon beta should be chosen rather than teriflunomide. (5)

Translations by Prescrire, where applicable.

©Prescrire 1 March 2015

"Teriflunomide (Aubagio°). Multiple sclerosis: just a metabolite of leflunomide" Prescrire Int 2015; 24 (158): 808-812. (Pdf, subscribers only)

1- "Teriflunomid (Aubagio) bei MS" Arznei-Telegramm 2014; 44 (12): 109-110.
2- "Nr 6 Teriflunomide; van antireuma- naar MS-middel" Pharm Sel 2014; 30: 29-31.
3- "Teriflunomide for multiple sclerosis" Drug Ther Bull 2014; 52 (7): 81-84.
4- "Teriflunomide" Australian Prescriber 2013; 36 (1): 1-2.
5- "Teriflunomide (Aubagio°). Multiple sclerosis: just a metabolite of leflunomide" Prescrire Int 2015; 24 (158): 808-812.

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