TRANSFORMS
Fingolimod
TRANSFORMS directly compared oral fingolimod with intramuscular interferon beta-1a and showed superior control of relapses over 1 year.
- Phase
- Phase III
- Population
- Relapsing-remitting multiple sclerosis (RRMS)
- Controlled period
- May 2006 — Sep 2008
What was compared
Fingolimod 0.5 mg
Orally once daily
Interferon beta-1a
30 μg intramuscularly once weekly
Additional randomized arm
Fingolimod 1.25 mg
Orally once dailyPrimary endpoint
Annualized relapse rate
12 months
Primary endpoint results
Annualized relapse rate
Relapses per participant-year
Both fingolimod doses were superior to interferon beta-1a (P<0.001).
Selected secondary outcomes
New or enlarged T2 lesions favored both fingolimod doses.
No significant difference among groups during the 1-year core.
Study population
- Randomized
- 1,292 randomized
- Age
- 18–55 years eligible
- Disability
- EDSS 0–5.5
- Disease definition
- Relapsing-remitting MS with recent relapse activity
Who entered the trial
Key inclusion criteria
- Relapsing-remitting multiple sclerosis
- Recent history of at least one relapse
- Baseline EDSS 0–5.5
Key exclusion criteria
- Inability to tolerate interferon beta-1a
- Major immune, malignant, pulmonary, or cardiac disease
- Pregnancy or breastfeeding
Safety signal
- Fingolimod-associated events included bradyarrhythmia, macular edema, hypertension, herpesvirus infections, and liver-enzyme elevation.
- Two fatal infections occurred in the 1.25 mg group.
Why it mattered
It was a pivotal active-comparator demonstration that an oral therapy could outperform a widely used injectable therapy on relapse and MRI outcomes.
Important limitation
The controlled comparison lasted only 1 year and did not demonstrate a disability-progression difference. The registry’s later completion date includes extension follow-up.