News:Top-line results of the TOPIC (Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis) trial were release today, April 25, 2013 and I had the opportunity to interview Dr. Aaron E. Miller (Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center) about the study, its results and his major takeaway messages.
Aubagio (teriflunomide) becomes the first and only oral medication for MS (multiple sclerosis) that also reduces the risk of conversion from a single demyelinating attack (clinically isolated syndrome or CIS) to a second attack (MS) -- a place previously held only by the self injectable medications.
TOPIC was similar in design to the other CIS trials -- see the study design at: http://www.clinicaltrials.gov/ct2/show/NCT00622700?term=topic+teriflunomide&rank=1
There were no unexpected safety or tolerability concerns and the dose response was consistent to what has been seen in trials of Aubagio for MS (TEMSO, TOWER and TENERE). Patients receiving Aubagio 14 mg orally daily had a 43% reduction n the risk of conversion to clinically definite MS (CDMS) compared to placebo (fake pill), over the two-year study period (p=0.0087), while those receiving 7 mg orally daily has a 37% reduction in the risk of conversion to CDMS compared to placebo.
Dr. Miller concluded that it is "important to treat early before a definitive diagnosis of MS can be made."
- Dr. Daniel Kantor, MD