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The Established Efficacy You Know

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BAFIERTAM has shown to reduce the number of relapses, delay the progression of disability, and slow the development of brain lesions.2

BAFIERTAM delivers the same efficacy as DMF, as shown in 2 pivotal clinical trials2,3,*

Additional endpoints at 2 years included the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 hypointense lesions, and the number of gadolinium-enhancing (Gd+) lesions, as well as the annualized relapse rate (ARR) and the time to confirmed disability progression. Confirmed disability progression was defined as at least a 1-point increase from the baseline Expanded Disability Status Scale (EDSS) score (1.5-point increase for patients with baseline EDSS of 0) sustained for 12 weeks.

Dosing:

Patients were randomized to receive DMF 240 mg twice a day (n=410), DMF 240 mg 3 times a day (n=416), or placebo (n=408) for up to 2 years

Age:

The median age was 39 years, median time since diagnosis was 4 years, and median EDSS score at baseline was 2

Duration:

The median time on the study drug for all treatment arms was 96 weeks. The percentages of patients who completed 96 weeks on the study drug per treatment group were

  • 69% for patients assigned to DMF 240 mg twice a day
  • 69% for patients assigned to DMF 240 mg 3 times a day
  • 65% for patients assigned to placebo groups

Additional endpoints at 2 years included the number of new or newly enlarging T2 hyperintense lesions, the number of T1 hypointense lesions, the number of Gd+ lesions, the proportion of patients relapsed, and the time to confirmed disability progression as defined in Study 1.

Dosing:

Patients were randomized to receive DMF 240 mg twice a day (n=359), DMF 240 mg 3 times a day (n=345), an open-label comparator (n=350), or placebo (n=363) for up to 2 years

Age:

The median age was 37 years, median time since diagnosis was 3 years, and median EDSS score at baseline was 2.5

Duration:

The median time on the study drug for all treatment arms was 96 weeks. The percentages of patients who completed 96 weeks on the study drug per treatment group were

  • 70% for patients assigned to DMF 240 mg twice a day
  • 72% for patients assigned to DMF 240 mg 3 times a day
  • 64% for patients assigned to placebo groups

DMF reduced the risk and frequency of relapse and disability progression

DEFINE

CONFIRM

Relative risk reduction in proportion of patients relapsed (PPR) at 2 years

Primary Endpoint

49%

Placebo: 46%;
DMF 27%
(P<.0001)

34%

Placebo: 41%;
DMF 29%
(P<.0020)

Relative reduction in annualized relapse rate (ARR) at 2 years

53%

Placebo: 0.364;
DMF 0.172
(P<.0001)

Primary Endpoint

44%

Placebo: 0.401;
DMF 0.224
(P<.0001)

Relative risk reduction in disability progression*

38%

Placebo: 27%;
DMF 16%
(P<.0050)

21%

Placebo: 17%;
DMF 13%
Not statistically
significant (P=.25)

DEFINE: Placebo n=408; DMF 240 mg BID n=410. CONFIRM: Placebo n=363; DMF 240 mg BID n=359.

BID=twice daily.
*Disability progression was defined as at least a 1-point increase from the baseline EDSS score (1.5-point increase for patients with baseline EDSS of 0) sustained for 12 weeks.

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See the results of the
new BAFIERTAM head-
to-head study

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BAFIERTAM offers
ease of administration

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DMF significantly reduced all studied measures of MRI activity2

Graphic depicting percentage of subjects with no new or newly enlarging lesions. Graphic depicting percentage of subjects with no new or newly enlarging lesions.

DEFINE

CONFIRM

Relative odds reduction in mean number of Gd+ lesions at 2 years

90%

Placebo: 1.8;
DMF 0.1
(P<.0001)

74%

Placebo: 2.0;
DMF 0.5
(P<.0001)

Relative reduction in mean number of new/newly enlarging T2 lesions over 2 years

85%

Placebo: 17;
DMF 2.6
(P<.0001)

71%

Placebo: 17.4;
DMF 5.1
(P<.0001)

Relative reduction in mean number of new T1 hypointense lesions over 2 years

73%

Placebo: 5.6;
DMF 1.5
(P<.0001)

57%

Placebo: 7.0;
DMF 3.0
(P<.0001)

DEFINE: Placebo n=165; DMF 240 mg BID n=152. CONFIRM: Placebo n=144; DMF 240 mg BID n=147.

Graphic depicting how DMF significantly reduced Gd+ lesions at 2 years. Graphic depicting how DMF significantly reduced Gd+ lesions at 2 years.

DEFINE

CONFIRM

Percentage of
subjects with

DMF

Placebo

DMF

Placebo

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 lesions

<1%

11%

3%

14%

CONFIRM

Percentage of
subjects with

DMF

Placebo

0 lesions

80%

61%

1 lesion

11%

17%

2 lesions

3%

6%

3 to 4 lesions

3%

2%

≥5 lesions

3%

14%

Based on studies conducted with DMF by Biogen Inc.

DEFINE: Placebo n=165; DMF 240 mg BID n=152. CONFIRM: Placebo n=144; DMF 240 mg BID n=147.

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A safety profile you can
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