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TECFIDERA Demonstrated Strong Efficacy Across 2 Pivotal Trials1-3

DEFINE Study: A 2-year, randomized, double-blind, placebo-controlled study of 1234 patients with RRMS. See Full Study Design

CONFIRM Study:
A 2-year, multicenter, randomized, double-blind, placebo-controlled study of 1417 patients with RRMS. See Full Study Design

Key clinical endpoints at 2 years–
TECFIDERA cut the risk and frequency of relapses in half1

DEFINE
CONFIRM
Placebo n=408; TECFIDERA n=410
Placebo n=363; TECFIDERA n=359
PPR*
Primary endpoint
49

Relative risk reduction

Placebo: 46%; TECFIDERA: 27%
(P<0.0001)

34

Relative risk reduction

Placebo: 41%; TECFIDERA: 29%
(P=0.0020)

ARR*
53

Relative reduction

Placebo: 0.364; TECFIDERA: 0.172
(P<0.0001)

Primary endpoint
44

Relative reduction

Placebo: 0.401; TECFIDERA: 0.224
(P<0.0001)

Disability Progression
38

Relative risk reduction

Placebo: 27%; TECFIDERA: 16%
(P=0.0050)

21

Relative risk reduction

Placebo: 17%; TECFIDERA: 13%
Not statistically significant (P=0.25)

84% of patients on TECFIDERA remained free of disability progression compared to 73% on placebo

*Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted for at least 24 hours and were accompanied by new objective neurologic findings.2,3
Disability progression was defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.2,3

Watch Dr. Fox discuss relapse reduction and what it means for patients

Watch Dr. Boster discuss the impact of delaying disability progression

Key MRI endpoints at 2 years–
TECFIDERA significantly reduced all measures of MRI activity1-4

DEFINE
CONFIRM
Placebo n=165; TECFIDERA n=152
Placebo n=144; TECFIDERA n=147
Gd+Lesions
90

Relative odds reduction

Placebo: 1.8; TECFIDERA: 0.1
(P<0.0001)

74

Relative odds reduction

Placebo: 2.0; TECFIDERA: 0.5
(P<0.0001)

New/NewlyEnlargedT2 Lesions
85

Relative reduction

Placebo: 17; TECFIDERA: 2.6
(P<0.0001)

71

Relative reduction

Placebo: 17.4; TECFIDERA: 5.1
(P<0.0001)

New T1 Lesions
72

Relative reduction

Placebo: 5.6; TECFIDERA: 1.5
(P<0.0001)

57

Relative reduction

Placebo: 7.0; TECFIDERA: 3.0
(P<0.0001)

Percentage of Patients With Gd+ Lesions at 2 Years
in the DEFINE Study

  TECFIDERAn=152 Placebon=165
0 lesions 93% 62%
1 lesion 5% 10%
2 lesions <1% 8%
3 to 4 lesions 0% 9%
5 or more lesions <1% 11%

Watch Dr. Hojnacki discuss key insights MRIs can reveal

DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS2; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis3; RRMS=relapsing-remitting multiple sclerosis; PPR=proportion of patients relapsed; ARR=annualized relapse rate; MRI=magnetic resonance imaging; Gd+=gadolinium-enhancing; EDSS=Expanded Disability Status Scale.

References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107. Erratum in: N Engl J Med. 2012;367(24):2362. 3. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097. Erratum in: N Engl J Med. 2012;367(17):1673. 4. Biogen, Data on file.