0.5 mg
 Placebo
 
Clinical endpoints
    
Annualised relapse rate (primary endpoint)
 0.18**
 0.40
 
Percentage of patients remaining relapse-free at 24 months
 70%**
 46%
 
Proportion with 3-month Confirmed Disability Progression†
 17%
 24%
 
Hazard ratio (95% CI)
 0.70 (0.52, 0.96)*
  
MRI endpoints
    
Median (mean) number of new or enlarging T2 lesions over 24 months
 0.0 (2.5)**
 5.0 (9.8)
 
Median (mean) number of Gd-enhancing lesions at Month 24
 0.0 (0.2)**
 0.0 (1.1)
 
Median (mean) % change in brain volume over 24 months
 -0.7 (-0.8)**
 -1.0 (-1.3)
 
Disability progression defined as 1-point increase in EDSS confirmed 3 months later

** p<0.001, *p<0.05 compared to placebo

All analyses of clinical endpoints were intent-to-treat. MRI analyses used eva luable dataset.

Study D2302 (TRANSFORMS) was a 1-year randomised, double-blind, double-dummy, active (interferon beta-1a)-controlled Phase III study of 1,280 patients (n=429 on 0.5 mg, 420 on 1.25 mg, 431 on interferon beta-1a, 30 µg by intramuscular injection once weekly). Median values for baseline characteristics were: age 36 years, disease duration 5.9 years, and EDSS score 2.0. Outcome results are shown in Table 2. There were no significant differences between the 0.5 mg and the 1.25 mg doses as regards study endpoints.

Table 2: Study D2302 (TRANSFORMS): Main results
Fingolimod

0.5 mg
 Interferon beta-1a, 30 μg
 
Clinical endpoints
    
Annualised relapse rate (primary endpoint)
 0.16**
 0.33
 
Percentage of patients remaining relapse-free at 12 months
 83%**
 71%
 
Proportion with 3-month Confirmed Disability Progression†
 6%
 8%
 
Hazard ratio (95% CI)
 0.71 (0.42, 1.21)
  
MRI endpoints
    
Median (mean) number of new or enlarging T2 lesions over 12 months
 0.0 (1.7)*
 1.0 (2.6)
 
Median (mean) number of Gd-enhancing lesions at 12 months
 0.0 (0.2)**
 0.0 (0.5)
 
Median (mean) % change in brain volume over 12 months
 -0.2 (-0.3)**
 -0.4 (-0.5)
 
† Disability progression defined as 1-point increase in EDSS confirmed 3 months later.

* p<0.01,** p<0.001, compared to interferon beta-1a

All analyses of clinical endpoints were intent-to-treat. MRI analyses used eva luable dataset.
Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple sclerosis therapy, disease activity or disability levels at baseline.

F