Neurology Xagena
TOPIC trial was designed to assess whether early initiation of Teriflunomide ( Aubagio ) in patients who experienced their first neurological symptoms consistent with clinically isolated syndrome ( CIS ) can prevent or delay conversion to clinically definite multiple sclerosis ( CDMS ).
Clinically isolated syndrome ( CIS ) is defined as a first clinical attack with features suggestive of multiple sclerosis. It typically occurs in young adults and is often a prelude to CDMS.
In the TOPIC trial, patients receiving Teriflunomide 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo.
In patients who received Teriflunomide 14 mg, a 43% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo ( p=0.0087 ); in patients who received Teriflunomide 7 mg, a 37% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo ( p=0.0271 ).
The average duration of Teriflunomide exposure in TOPIC was approximately 16 months.
Adverse events observed in the trial were consistent with previous clinical trials with Teriflunomide in multiple sclerosis.
The most common types of adverse events reported more frequently in the Teriflunomide arms were ALT ( alanine transaminase ) elevations, nasopharyngitis, headache, hair thinning, diarrhea and paresthesia.
There were no deaths reported in either Teriflunomide group over the course of the study. There was one death due to suicide in the placebo arm.
The rate of treatment discontinuation due to adverse events was similar across treatment arms ( 9.1% in placebo arm, compared to 12.1% in 7 mg Teriflunomide arm and 8.3% in 14 mg Teriflunomide arm ).
The trial compared treatment with either 14 mg or 7 mg once-daily, oral Teriflunomide against placebo.
This double-blind, multi-center trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of multiple sclerosis symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of multiple sclerosis. ( Xagena )
Source: Sanofy - Genzyme, 2013
XagenaMedicine_2013
