PURPOSE: The purpose was to summarize US prescribing information for 
teriflunomide in the treatment of patients with relapsing forms of multiple 
sclerosis (RMS), with reference to clinical efficacy and safety outcomes.
METHODS: In September 2012, the US Food and Drug Administration granted approval 
for the use of teriflunomide, 14 mg and 7 mg once daily, to treat RMS on the 
basis of the results of a Phase II study and the Phase III TEMSO (Teriflunomide 
Multiple Sclerosis Oral) trial. After recent updates to the prescribing 
information (October 2014), key findings from these and 2 other Phase III 
clinical trials, TOWER (Teriflunomide Oral in People With Relapsing Multiple 
Sclerosis) and TOPIC (Oral Teriflunomide for Patients with a First Clinical 
Episode Suggestive of Multiple Sclerosis), and practical considerations for 
physicians are summarized.
FINDINGS: Teriflunomide, 14 mg and 7 mg, significantly reduced mean number of 
unique active lesions on magnetic resonance imaging (MRI; P < 0.05 for both 
doses) in the Phase II study. In the TEMSO and TOWER studies, the 14-mg dose of 
teriflunomide significantly reduced annualized relapse rate (31% and 36% 
relative risk reduction compared with placebo, respectively; both P < 0.001) and 
risk of disability progression sustained for 12 weeks (hazard ratio vs placebo 
0.70 and 0.69, respectively; both P < 0.05). The 7-mg dose significantly 
(P < 0.02) reduced annualized relapse rate in both studies, although the 
reduction in risk of disability progression was not statistically significant. 
Teriflunomide treatment was also associated with significant efficacy on MRI 
measures of disease activity in TEMSO; both doses significantly reduced total 
lesion volume and number of gadolinium-enhancing T1 lesions. TOPIC evaluated 
patients with a first clinical event consistent with acute demyelination and 
brain MRI lesions characteristic of multiple sclerosis. More patients were free 
of relapse in the teriflunomide 14-mg and 7-mg groups than in the placebo group 
(P < 0.05 for both comparisons). In safety data pooled from the 4 studies, 
adverse events occurring in ≥2% of patients and ≥2% higher than in the placebo 
group were headache, alanine aminotransferase increase, diarrhea, alopecia (hair 
thinning), nausea, paresthesia, arthralgia, neutropenia, and hypertension. 
Routine monitoring procedures before and on treatment are recommended to assess 
potential safety issues. Women of childbearing potential must use effective 
contraception and, in the event of pregnancy, undergo an accelerated elimination 
procedure to reduce plasma concentrations of teriflunomide.
IMPLICATIONS: Clinical evidence suggests that teriflunomide is an effective 
therapeutic choice for patients with RMS, both as an initial treatment and as an 
alternative for patients who may have experienced intolerance or inadequate 
response to a previous or current disease-modifying therapy.