Tecfidera – How Well It Works

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The effectiveness of TECFIDERA (also known as BG12) in people with relapsing-remitting MS or RRMS has been tested in a Phase 2b study and two Phase 3 studies (DEFINE and CONFIRM).

 

Phase 2b study

The Phase 2b study was a randomized, double-blind, placebo-controlled study that included 257 people with RRMS. A range of Tecfidera doses were evaluated, with 64 people randomly assigned to receive Tecfidera 120 mg once daily, 64 to receive Tecfidera 120 mg three times daily, 64 to receive Tecfidera 240 mg three times daily, and 65 to receive placebo. The highest dose of Tecfidera resulted in a significant reduction (69%) in gadolinium (Gd for short)-enhancing brain lesions seen by magnetic resonance imaging or MRI compared with placebo. Tecfidera also resulted in a significant decrease in the number of new T2 MRI lesions (a 48% decrease) compared with placebo. Additionally, people who received Tecfidera (the highest dose) also had significantly lower annual rate of relapses (32% lower) compared with placebo.

 

Phase 3 study: DEFINE

The Phase 3 DEFINE study was a 2-year randomized, placebo-controlled study, which included over 1,200 people with RRMS. The primary efficacy outcome (the key measure used to determine the effectiveness of the medication) was the percentage of subjects who relapsed at 2 years. Both doses of Tecfidera (240 mg twice and three times daily) resulted in significantly lower percentage of people with relapses, with the 240 mg twice daily dose resulting in a 49% lower rate of relapses compared with placebo. Additionally, compared with placebo, Tecfidera resulted significantly greater reductions in the annual rate of relapses, the number of new or enlarging T2 lesions on MRI (an 85% decrease), the number of new Gd-enhancing lesions (a 90% decrease), and the percentage of subjects with progression of disability at 2 years (a 38% decrease in risk compared with placebo).

Results from DEFINE: Tecfidera vs placebo

Tecfidera 240 mg
Twice daily
(N=410)

Placebo
(N=408)

P-value

Clinical endpoints

Patients with relapse at 2 years (%) 27% 46% <0.0001
Annualized rate of relapse 0.172 0.364 <0.0001
Progressed patients at 2 years (%) 16% 27% 0.005

MRI endpoints

Number of new or enlarging T2 lesions over 2 years (mean) 2.6 17 <0.0001
Number of Gd-enhancing lesions at 2 years (mean) 0.1 1.8 <0.0001

 

Phase 3 study: CONFIRM

The Phase 3 CONFIRM study (CONFIRM stands for Comparator and an Oral Fumarate In RRMS) was a randomized, double-blind, placebo-controlled, dose-comparison study comparing Tecfidera and Copaxone (glatiramer acetate) with placebo in 1,430 people with RRMS. Tecfidera resulted in significant treatment effects versus placebo across all major efficacy outcome measures. In all cases these effects were greater than those seen with Copaxone.

Results from CONFIRM: Tecfidera vs placebo

Tecfidera 240 mg
Twice daily
(N=359)

Placebo
(N=363)

P-value

Clinical endpoints

Annualized rate of relapse 0.224 0.401 <0.0001
Patients relapsing (%) 29% 41% 0.002

MRI endpoints

Number of new or enlarging T2 lesions over 2 years (mean) 5.1 17.4 <0.0001
Patients with no new lesions (%) 27% 12%
Number of Gd-enhancing lesions at 2 years (mean) 0.5 2.0 <0.0001

 

Tecfidera 240 mg, given either twice daily or three times daily, resulted in a significantly lower annual rate of relapse (the primary efficacy outcome) compared with placebo at 2 years, 44% lower for the twice daily dose and 51% lower for the three times daily dose (P<0.0001). By comparison, Copaxone resulted in a 29% lower annual rate of relapse versus placebo (P<0.02). In addition to the primary endpoint, Tecfidera also resulted in significantly greater reduction new or newly enlarging T2 MRI lesions compared with placebo, 71% lower for twice daily and 73% lower for three-times daily dose (P<0.0001). By comparison, Copaxone resulted in a 54% reduction (P<0.0001). Tecfidera resulted in a greater percentage of people who were relapse-free compared with placebo, 34% lower for the twice daily dose (P<0.003) and 45% lower for the three-times daily dose (P<0.0001). By comparison, Copaxone resulted in a 29% reduction versus placebo (P<0.01).

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