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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

TECFIDERA reduced the risk and frequency of relapse and disability progression1

DEFINE
CONFIRM
Placebo n=408; TECFIDERA n=410
Placebo n=363; TECFIDERA n=359
PPR at 2 Years*
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 at 2 Years*
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)

*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

TECFIDERA significantly reduced all studied measures of MRI activity1-4

DEFINE
CONFIRM
Placebo n=165; TECFIDERA n=152
Placebo n=144; TECFIDERA n=147
Mean Number of New/Newly Enlarging T2 Lesions Over 2 Years
85

Relative reduction

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

71

Relative reduction

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

Mean Number of Gd+ Lesions at 2 Years
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)

Mean Number of New T1 Lesions Over 2 Years
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 and CONFIRM Studies

  DEFINE CONFIRM
  TECFIDERAn=152 Placebon=165 TECFIDERAn=147 Placebon=144
0 lesions 93% 62% 80% 61%
1 lesion 5% 10% 11% 17%
2 lesions <1% 8% 3% 6%
3 to 4 lesions 0% 9% 3% 2%
5 or more lesions <1% 11% 3% 14%