Saturday, 27 April 2013

Teriflunomide for CIS

First oral treatment that is likely to get a license for CIS #MSBlog #MSResearch

Genzyme-Sanofi  announce positive results from the TOPIC trial for teriflunomide. The trial waCalendars designed to assess whether early initiation of teriflunomide in CISers can prevent or delay conversion to clinically definite multiple sclerosis (CDMS).

In the TOPIC trial, CISers received teriflunomide 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, compared to placebo.

Primary results were: In CISers who received teriflunomide 14 mg, a 43 per cent 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 per cent 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 MS. 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 per cent in placebo arm, compared to 12.1 per cent in 7 mg teriflunomide arm and 8.3 per cent in 14 mg teriflunomide arm).  




"These results are consistent with the phase 3 trials in RRMS and are not unexpected. They will make a difference if teriflunomide gets a license for CIS; a tablet will be more desirable than the injectable treatments."

2 comments:

  1. See the results of the ORACLE trial below of the now defunct Movectro.

    What an oppertunity lost to MSers!!!!

    It drops the development by 70% and I suspect that many of those people on drug where if failed did so because getting the drug was too late, because if you look at MRI data most of activity is in first three months and then it flat lines.

    ReplyDelete
  2. Pleased that Aubagio has an effect too

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.