Table 3.

Summary of fingolimod trials

Study	Study design	Treatment in study	Primary end points	Eligibility criteria	Main results
Kappos et al43	Phase II, 6-month, doubleblind, parallel-group, placebo-controlled, multicenter	fingolimod 5 mg orally, daily fingolimod1.25 mg orally, daily/placebo	Total no of Gd+ lesions on T1-w MRI at month 6	RRMS, SPMS 18–60 years EDSS 0–6, no evidence of relapse in the last 30 days	Patients free from Gd+ lesions: 82%*
Cohen et al46 (TRANSFORMS)	Phase III, 12-month, doubleblind, double-dummy, parallel-group, active-controlled, multicenter	fingolimod 1.25 mg orally, daily fingolimod0.5 mg orally, daily IFNβ-1a 30 μg intramuscularly, weekly	ARR over 12 months	RRMS 18–55 years EDSS 0–5.5, recent history of relapse	ARR: 0.20*; 0.16* Patients free from relapses: 79.8%*; 82.6%*
Kappos et al47 (FREEDOMS)	Phase III, 24-month, doubleblind, parallel-group, placebo-controlled, multicenter	fingolimod 1.25 mg orally, daily fingolimod 0.5 mg orally, daily/placebo	ARR over 24 months	RRMS 18–55 years EDSS 0–5.5, recent history of clinical relapse	ARR: 0.16*; 0.18* Patients free from relapses: 74.7% ± 2.2%* 70.4% ± 2.3%*

Note: ^*P < 0.001.

Abbreviations: ARR, annualized relapse rate for confirmed relapses; EDSS, expanded disability status scale; Gd⁺, gadolinium-enhanced; IFNβ-1a, interferon beta-1a; MRI, magnetic resonance imaging; RRMS, relapsing–remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis; T₁.-w: T₁-weighted.