The U.S. Food and Drug Administration has approved teriflunomide
once-daily pills (Aubagio® Genzyme, a Sanofi company) to treat
relapsing forms of MS. Aubagio (pronounced oh-BAH-gee-oh) is a
novel oral compound that inhibits the function of specific immune
cells that have been implicated in MS. Aubagio can inhibit a key
enzyme required by white blood cells (lymphocytes), reducing the
proliferation of T and B immune cells active in MS and also
inhibiting the production of immune messenger chemicals by T
cells. It is not thought to affect resting immune cells that are
not in an activated state. Two doses (7mg and 14 mg) have been
approved in the United States.
The Studies: Three large clinical trials of
Aubagio have been completed, and at least two more are ongoing.
In the phase III TEMSO study, Aubagio reduced the average number of MS
relapses and disease activity on MRI scans significantly more
than inactive placebo in 796 people with relapsing forms of MS.
In a recently completed phase III TOWER study involving 1,169
people with relapsing-remitting MS, oral Aubagio reduced relapses
compared with placebo over at least 48 weeks, according to a
company press release. Of two different doses tested during the
TOWER trial (7 mg and 14 mg), the higher dose also slowed
progression of disability.
In another study, called TENERE, Aubagio was compared with Rebif®
(interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and
did not reach its primary endpoint (the main question posed by
the study) — the “risk of failure,” meaning the first occurrence
of a relapse, or permanent discontinuation of the study
treatment, whichever came first. There was no significant
difference in the numbers of participants who experienced events
defined as treatment failure among the Aubagio and Rebif
groups.
In trials to date, Aubagio was generally safe and well tolerated.
The most common side effects experienced by participants in
clinical trials include diarrhea, abnormal liver tests, nausea,
flu, and hair thinning. The prescribing information includes a
boxed warning related to the potential for liver damage in
persons taking Aubagio.
Canada played an instrumental role in the development of
teriflunomide, specifically in leading Phases II and III of the
TEMSO study with significant involvement of researchers,
clinicians and patients from the Canadian Network of MS Clinics.
The MS Society of Canada will provide updates on continued trials
and/or other information related to teriflunomide in Canada.
With information from the National MS Society (USA) www.nmss.org