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agate
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Joined: 17 May 2006
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 Posted: Sun May 21, 2006 11:44 pm Post subject: (MS Society Research Update) Oral teriflunomide for MS |
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May 12, 2006
POSITIVE RESULTS REPORTED FOR ORAL TERIFLUNOMIDE FOR RELAPSING MS
An experimental oral drug being tested for multiple sclerosis, called teriflunomide (Sanofi-Aventis), significantly reduced MRI-detected disease activity in a 36-week, Phase II clinical trial involving 179 people with relapsing MS. Teriflunomide is an agent that may modulate T cells, which drive the immune attack in MS. Paul O’Connor, MD (University of Toronto) and colleagues originally reported these results at the 2004 Congress of the European Committee for Treatment and Research in MS, and have now published the findings in Neurology (2006 Mar 28;66(6):894-900).
Dr. O’Connor and his team recruited 157 people with relapsing-remitting MS (characterized by clearly defined flare-ups followed by partial or complete recovery periods), and 22 people with secondary-progressive MS (a secondary stage of the disease involving a steadily worsening course, occurring with or without relapses) with relapses.
Participants were randomly assigned to receive inactive placebo, or one of two doses (7 mg or 14 mg) of teriflunomide, once daily for 36 weeks. The primary objective of the study was to determine the effect of treatment on the average number of active areas of disease activity (lesions) observed on MRI scans taken every six weeks. Secondary objectives included the frequency of relapses, and any increase in disability as measured by the EDSS, a standard scale.
Both treatment doses were associated with reduced numbers of active lesions compared with placebo. Significantly fewer people in the group taking the higher dose showed an increase in the EDSS than those in the placebo group. The drug was well tolerated; adverse events included headache and upper respiratory tract infection, and were similar among all three groups.
A larger study of teriflunomide is underway in people with relapsing-remitting MS in North America and Europe; more information is available on the ClinicalTrials.gov Web site, at http://www.clinicaltrials.gov/ct/show/NCT00134563.
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