By John Gever, Deputy Managing Editor, MedPage Today
Published: April 25, 2013
Patients diagnosed with clinically isolated syndrome after experiencing a first multiple sclerosis-like attack were significantly less likely to have a second — conferring a definite MS diagnosis — after receiving the oral drug teriflunomide (Aubagio), its manufacturer said.
Conversion rates were reduced by 37% with teriflunomide doses of 7 mg/day and by 43% with 14 mg/day compared with placebo during a 2-year phase III trial called TOPIC, according to Genzyme.
Mean actual duration of treatment in the study was 16 months. Discontinuation rates reported by the company were similar in all three study arms, ranging from 8% to 12%.
Other quantitative data were not released. Genzyme said adverse events were similar to those seen in other teriflunomide studies, including elevations in alanine aminotransferase, nasopharyngitis, headache, hair thinning, diarrhea, and paresthesia.
Full study results will be submitted for presentation at a scientific meeting later this year, the company said.
In addition to conversion to clinically definite MS, the study’s primary endpoint, outcome measures included progression of MS-like lesions in MRI scans, annualized relapse rate, volume of abnormal brain tissue, and scores on clinical measures of disability and fatigue.
Teriflunomide was approved for relapsing forms of MS last September.
Source: Medpage today
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