Figure 1: Time to 12-Week Confirmed Progression of Disability (Study 1)

Study 2: Placebo-Controlled Trial in RRMS

Study 2 was a 2-year multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm in patients with RRMS. The primary endpoint was the annualized relapse rate at 2 years. Additional endpoints at 2 years included the number of new or newly enlarging T2 hyperintense lesions, number of T1 hypointense lesions, number of Gd+ lesions, proportion of patients relapsed, and time to confirmed disability progression as defined in Study 1.

Patients were randomized to receive Tecfidera 240 mg twice a day (n=359), Tecfidera 240 mg three times a day (n=345), an open-label comparator (n=350), or placebo (n=363) for up to 2 years. The median age was 37 years, median time since diagnosis was 3 years, and median EDSS score at baseline was 2.5. The median time on study drug for all treatment arms was 96 weeks. The percentages of patients who completed 96 weeks on study drug per treatment group were 72% for patients assigned to Tecfidera 240 mg twice a day, 70% for patients assigned to Tecfidera 240 mg three times a day and 64% for patients assigned to placebo groups.

Tecfidera had a statistically significant effect on the relapse and MRI endpoints described above. There was no statistically significant effect on disability progression. The Tecfidera 240 mg three times daily dose resulted in no additional benefit over the Tecfidera 240 mg twice daily dose. The results for this study (240 mg twice a day vs. placebo) are shown in Table 3.

Table 3: Clinical and MRI Results of Study 2   Tecfidera Placebo P-value
  240 mg BID    
Clinical Endpoints N=359 N=363  
Annualized relapse rate 0.224 0.401 <0.0001
   Relative reduction (percentage) 44%    
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