TEMSO
Teriflunomide
TEMSO established once-daily oral teriflunomide as a relapse-reducing therapy and showed a disability effect at the 14 mg dose.
- Phase
- Phase III
- Population
- Relapsing multiple sclerosis (RMS)
- Controlled period
- Sep 2004 — Jul 2010
What was compared
Intervention
Teriflunomide 14 mg
Orally once daily
Comparator
Placebo
Matching oral tablet once daily
Additional randomized arm
Teriflunomide 7 mg
Orally once daily1,088 randomized108 weeks controlled phase
Primary endpoint
Prespecified outcome
Annualized relapse rate
108 weeks
Outcome figure
Primary endpoint results
Intervention Comparator or reference
Annualized relapse rate
Relapses per participant-year
31.5% and 31.2% relative reductions (P<0.001 for both doses).
Selected secondary outcomes
12-week confirmed disability progression
20.2% with 14 mg versus 27.3% with placebo (P=0.03).
MRI
Both doses were superior to placebo across prespecified MRI outcomes.
Study population
- Randomized
- 1,088 randomized
- Age
- 18–55 years eligible
- Sex
- 783 women (72% of 1,086 with posted baseline data)
- Disability
- EDSS 0–5.5
- Disease definition
- Relapsing MS with recent clinical activity
Who entered the trial
Key inclusion criteria
- Relapsing clinical course, with or without progression
- At least one relapse in 1 year or two relapses in 2 years
- Clinically stable before randomization and EDSS no higher than 5.5
Key exclusion criteria
- Clinically important cardiovascular, hepatic, neurologic, endocrine, or systemic disease
- Significantly impaired bone-marrow function
- Pregnancy, breastfeeding, or prior specified immunosuppressant use
Safety signal
- Diarrhea, nausea, and hair thinning were more common with teriflunomide.
- Mild alanine aminotransferase elevation was more frequent; marked elevation and serious infection rates were similar among groups.
Why it mattered
TEMSO provided pivotal evidence for a convenient oral immunomodulator with effects on relapses and, at the approved 14 mg dose, confirmed disability progression.
Important limitation
The study tested two doses and several MS courses; interpretation of the disability result is specific to the 14 mg comparison.