OCTOBER 6, 2011 | Paul O'Connor, M.D., Jerry S. Wolinsky, M.D., Christian Confavreux, M.D., Giancarlo Comi, M.D., Ludwig Kappos, M.D., Tomas P. Olsson, M.D., Ph.D., Hadj Benzerdjeb, M.D., Philippe Truffinet, M.D., Lin Wang, Ph.D., Aaron Miller, M.D., and Mark S. Freedman, M.D., for the TEMSO Trial Group*
The TEMSO trial, a randomized, double-blind, placebo-controlled study, evaluated the efficacy and safety of oral teriflunomide in patients with relapsing multiple sclerosis. The study included 1088 patients aged 18 to 55 years, with a score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS) and at least one relapse in the previous year or two relapses in the previous 2 years. Patients were randomly assigned to receive placebo, 7 mg, or 14 mg of teriflunomide daily for 108 weeks. The primary endpoint was the annualized relapse rate, and the key secondary endpoint was confirmed disability progression for at least 12 weeks.
Key findings included:
- Teriflunomide significantly reduced the annualized relapse rate (0.37 vs. 0.54 for placebo, P<0.001).
- The proportion of patients with confirmed disability progression was lower in the teriflunomide groups (20.2% at 14 mg vs. 27.3% with placebo, P=0.02).
- Both teriflunomide doses showed superior MRI outcomes compared to placebo, including reduced total lesion volume and fewer gadolinium-enhancing lesions.
- Common adverse events included diarrhea, nausea, and hair thinning, with no significant differences in serious adverse events or discontinuation rates.
- Elevated alanine aminotransferase levels were more common with teriflunomide (54.0% at 7 mg, 57.3% at 14 mg vs. 35.9% with placebo).
The study concluded that teriflunomide is an effective oral monotherapy for relapsing multiple sclerosis, reducing relapse rates and disability progression, and suppressing active inflammatory lesions on MRI.The TEMSO trial, a randomized, double-blind, placebo-controlled study, evaluated the efficacy and safety of oral teriflunomide in patients with relapsing multiple sclerosis. The study included 1088 patients aged 18 to 55 years, with a score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS) and at least one relapse in the previous year or two relapses in the previous 2 years. Patients were randomly assigned to receive placebo, 7 mg, or 14 mg of teriflunomide daily for 108 weeks. The primary endpoint was the annualized relapse rate, and the key secondary endpoint was confirmed disability progression for at least 12 weeks.
Key findings included:
- Teriflunomide significantly reduced the annualized relapse rate (0.37 vs. 0.54 for placebo, P<0.001).
- The proportion of patients with confirmed disability progression was lower in the teriflunomide groups (20.2% at 14 mg vs. 27.3% with placebo, P=0.02).
- Both teriflunomide doses showed superior MRI outcomes compared to placebo, including reduced total lesion volume and fewer gadolinium-enhancing lesions.
- Common adverse events included diarrhea, nausea, and hair thinning, with no significant differences in serious adverse events or discontinuation rates.
- Elevated alanine aminotransferase levels were more common with teriflunomide (54.0% at 7 mg, 57.3% at 14 mg vs. 35.9% with placebo).
The study concluded that teriflunomide is an effective oral monotherapy for relapsing multiple sclerosis, reducing relapse rates and disability progression, and suppressing active inflammatory lesions on MRI.