|What is it?||Aubagio® (teriflunomide), a pyrimidine synthesis inhibitor, is an oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat rheumatoid arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes) – which in turn reduces the proliferation of T and B immune cells that are active in MS and also inhibits the production of immune messenger chemicals by T cells.|
|What does it do?||In a two-year study, Aubagio reduced yearly relapses by nearly a third compared to placebo. It also slowed the progression of the disease.|
|How does it work?||Aubagio acts in multiple sclerosis by reducing white blood cells through effects on DNA synthesis.|
|Clinical Results and FDA approval||FDA approval of Aubagio was on September 12, 2012 for patients with relapsing forms of MS.
In phase III trial, TEMSO, compared to placebo the higher dose of Aubagio (14mg) reduced relapse rate 31%, 3 month disability progression 30%, and total MRI lesion volume 67%.
|How is it taken?||Aubagio is a daily pill. It is available in doses of 7mg and 14mg. There is a better effect on the disease if patients taking the 14mg dose and the side effect profile are comparable between the two|
|What are the side effects ?||Common Aubagio side effects may include:
-or abnormal liver function tests.
Patients taking this drug were potentially more susceptible to hair loss (13% vs 3% in placebo), diarrhea (18% vs. 9% in placebo) and nausea (14% vs. 7% placebo) Serious effects on the fetus have been seen with a drug similar to Aubagio, leflunomide, which might apply to Aubagio as well. For this reason the FDA has recommended not taking this drug within two years of trying to conceive a child unless a wash out procedure is performed. Because the drug may potentially cross into the sperm this also applies to men.
A TB test should be performed prior to starting this drug as should basic bloodwork.
Because mild liver irritation or damage (57% vs. 36% placebo) can occur blood is monitored monthly for six months.