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The DEFINE Trial

The DEFINE trial included patients who were new to relapsing MS treatment and patients who were treatment‐experienced1

DEFINE Trial Design
DEFINE Trial Design

Primary

Proportion of patients relapsed (PPR)

Additional

  • Annualized relapse rate (ARR)
  • Time to confirmed disability progression
  • Number of new or newly enlarging T2 hyperintense lesions
  • Number of Gd+ lesions
  • Number of new T1 hypointense lesions

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Primary progressive multiple sclerosis, secondary progressive multiple sclerosis, or progressive relapsing multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Neurological evaluations
Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations
Performed in 48% of patients at baseline, month 6, and years 1 and 2

69% of patients treated with TECFIDERA BID completed 96 weeks of treatment compared to 65% of patients taking placebo2

The CONFIRM Trial

The CONFIRM trial included patients who were new to relapsing MS treatment and patients who were treatment‐experienced3

CONFIRM Trial Design
CONFIRM Trial Design

Primary

Annualized relapse rate
(ARR)

Additional

  • Proportion of patients relapsed (PPR)
  • Time to confirmed disability progression
  • Number of new or newly enlarging T2 hyperintense lesions
  • Number of Gd+ lesions
  • Number of new T1 hypointense lesions

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Progressive forms of multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Neurological evaluations
Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations
Performed in 48% of patients at baseline, month 6, and years 1 and 2

70% of patients treated with TECFIDERA BID completed 96 weeks of treatment compared to 64% of patients taking placebo2

*Study also randomized patients (n=416) to a 240 mg TID arm. TID dosing resulted in no additional benefit over 240 mg BID.2
Study also randomized patients (n=345) to a 240 mg TID arm. TID dosing resulted in no additional benefit over 240 mg BID.2
Disease activity: any change in relapse frequency, MRI activity, and/or disability progression.

DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS1; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis3; Gd+=gadolinium-enhancing; EDSS=Expanded Disability Status Scale; PO=taken orally; TID=three times per day; BID=twice per day.

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