Teriflunomide (Aubagio, Genzyme/Sanofi) is coming into the MS market [1]. It is an oral drug, nice.

Efficacy: 

“30% lower than the rate for those taking a placebo,” said Russell Katz, MD,”   What does that mean?

Maybe not as clear as just a percent reduction in releases, think compounding. Sagepub has an article [2] discussing this topic. One thing is for sure you need all the intimate details of a study to know what was really measured. After several  years the number of relapses may have fallen by a much greater amount than 30% mentioned.  The efficacy of RRMS  Drugs (Relapsing Remitting Multiple Sclerosis) is measured in how well it decreases the annualized relapse rates (ARR).

The new form of MS drugs: Oral

Such rates are  subject to interpretation and statistical manipulation.

Quoting [2] :

“…Out of the 72 randomized control trials, 56 (77.8%) articles had defined relapse or exacerbation, while 17 (23.7%) did not define the term relapse or exacerbation. Of these 56 articles, the study population consisted of 37 (66.1%) with RRMS, 8 (14.3%) were either RRMS or SPMS, and 11 (19.6%) involved other or unknown MS categories…”

The patient taking Aubagio has to accept the  following liver risks:

“…A boxed warning will alert prescribers to the risk for liver problems, including death, and a risk for birth defects with use of teriflunomide. “Physicians should do blood tests to check liver function before a patient starts taking Aubagio, and periodically during treatment,” the FDA statement notes…”

Technically, this is how Aubagio works:

“…Teriflunomide is a once-daily oral immunomodulator developed as a disease-modifying therapy for MS. It reversibly inhibits …a key mitochondrial enzyme involved in  pyrimidine synthesis for DNA replication. As a result, the drug reduces T- and B-cell proliferation and function in response to autoantigens but preserves the replication and function of cells 

Lexicon:

  • Mitochondrion :  membrane-enclosed organelle, or mini organ, at the cellular level

Sources:

  1. Medscape ; “FDA Approves Second Oral Drug for MS” ; Sep 2012
  2.  sagepub ; Multiple Sclerosis ; “”Assessing changes in relapse rates in multiple sclerosis” ; 2010

2 Comments for this entry

  • Samuel Hunter says:

    Aubagio will be the first MS drug to market with the distinction that it’s studies show impact on relapse, disability, and MRI. These were not mild patients with MS, like some other studies. While Aubagio does not distinguish itself on efficacy against interferon-beta, it is much better tolerated than interferon.

  • Jennifer says:

    With the soon to be release of the oral drug, Aubagio, id this similar to Tysabri where it cuts down on Flare-Ups?

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