June 27, 2014
Teriflunomide: Positive Results Reported Following a Phase III Study
Results from a Phase III study involving a new oral disease-modifying therapy, teriflunomide, an agent that inhibits specific immune cells, was shown to reduce relapse rates, disability progression and MRI evidence of disease activity as compared with placebo. Further studies are ongoing to determine the long term effectiveness and safety of the drug.
Researchers from the Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group reported positive results from a Phase III, randomized, double-blinded, placebo-controlled, parallel group study involving 1088 people between the ages of 18 and 55 years of age with relapsing MS. Patients were randomly assigned to placebo, 7mg of teriflunomide, or 14mg of teriflunomide once daily for 108 weeks.
The trial looked at safety and efficacy in reducing the frequency of relapses and progression of physical disability over a two-year period. Teriflunomide was found to significantly reduce relapses by 31.2% and 31.5% on a one-daily oral dose of 7mg and 14mg respectively. The higher dosage was shown to reduce the risk of disease progression. Beneficial changes were also seen in the MRI scans of treated patients including a 70% reduction in new lesions at the higher 14mg dose.
Some adverse effects included diarrhea, nausea, and hair thinning or decreased hair density. No differences in serious side effects between patients on the drug and placebo were reported. Further studies are ongoing to determine the long term effectiveness and safety of the drug.
The MS Society of Canada will provide updates on continued trials and/or the status of the treatment’s approval should a Health Canada approval be sought through an application to the Common Drug Review or Conseil du Médicament (Québec).