Date: 2013-10-03
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS)
Company: Genzyme (USA - MA), a Sanofi company (France)
Product: Aubagio® (teriflunomide)
Action
mechanism: Teriflunomide, a once-daily, oral tablet, is an immunomodulator with a unique mechanism of action. Although the mechanism of action for teriflunomide is not fully understood, research supports that teriflunomide inhibits the proliferation of stimulated T and B lymphocytes in the periphery thought to be responsible for the damaging inflammatory process in MS, while generally maintaining normal immune function.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial details:
Latest
news: * On October 3, 2013, Genzyme, a Sanofi company, has announced new data from the TOPIC study of its once-daily, oral Aubagio® (teriflunomide). These new data, presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), include the following:-Aubagio® 14 mg significantly reduced the risk of a new clinical relapse or MRI lesion over the two-year study period. There was a 35 percent reduction among patients who received Aubagio® 14 mg compared to placebo (p=0.0003).As measured by MRI over the two-year study period, there was a 5 percent increase in total lesion volume among patients treated with Aubagio® 14 mg compared to a 28 percent increase among patients treated with placebo (p=0.0374). In addition, there was a 59 percent reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio® 14 mg compared to placebo (p=0.0008).Similar results were observed for the 7 mg dose, though the effects did not achieve statistical significance on some endpoints.The TOPIC trial was designed to assess whether early initiation of Aubagio® in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack, i.e., conversion to clinically definite multiple sclerosis (CDMS).As previously announced, patients receiving Aubagio® 14 mg and 7 mg in the TOPIC trial were significantly less likely than placebo to develop CDMS, the primary endpoint. Compared to placebo, Aubagio® 14 mg reduced the risk of conversion to CDMS by 43 percent.The average duration of Aubagio® exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with Aubagio® in MS. The most common types of adverse events reported more frequently in the Aubagio® arms were ALT (Alanine aminotransferase) elevations, headache, hair thinning, diarrhea, paresthesia and upper respiratory tract infection. There were no deaths reported in either Aubagio 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 (9.9 percent in placebo arm, compared to 12.1 percent in 7 mg Aubagio® arm and 8.3 percent in 14 mg Aubagio® arm).The trial compared treatment with either 14 mg or 7 mg once-daily, oral Aubagio® 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 MS symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of MS.* On April 24, 2013, Genzyme has announced positive top-line results from the TOPIC trial for Aubagio® (teriflunomide). The trial was designed to assess whether early initiation of 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). In the TOPIC trial, patients receiving Aubagio® 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. Additional results, including key secondary and tertiary objectives, will be presented at a forthcoming scientific meeting.Primary results were:• In patients who received Aubagio® 14 mg, a 43 percent 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 Aubagio® 7 mg, a 37 percent 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 Aubagio® exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with Aubagio® in MS. The most common types of adverse events reported more frequently in the Aubagio® 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 percent in placebo arm, compared to 12.1 percent in 7 mg teriflunomide arm and 8.3 percent in 14 mg teriflunomide arm).The trial compared treatment with either 14 mg or 7 mg once-daily, oral Aubagio® 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 MS symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of MS.
