TYSABRI OFFERS POWERFUL EFFICACY

Patients demonstrated statistically significant results, as evidenced by key parameters in the 2-year AFFIRM trial1

AFFIRM study description: The AFFIRM (NAtalizumab Safety and EFFIcacy in Relapsing-Remitting MS) study was a pivotal 2-year, double-blind, randomized, controlled trial with 942 relapsing MS patients who received either TYSABRI therapy (300 mg by intravenous infusion [n=627]) or placebo (n=315) every 4 weeks for up to 28 months (30 infusions).1-3

  • Exclusion criteria included patients with primary progressive, secondary progressive, or progressive relapsing MS
  • The primary endpoint at 2 years was time to onset of sustained increase in disability, defined as an increase of ≥1.0 point on the EDSS from a baseline of ≥1.0 that was sustained for 12 weeks, or a ≥1.5-point increase on the EDSS from a baseline EDSS of 0 that was sustained for 12 weeks. Increases excluded disability confirmation within 30 days of a relapse

Baseline characteristics of patients in the AFFIRM trial1,2

94% of patients in the 2-year, AFFIRM pivotal trial were treatment naïve to platform therapya

  • 5 years median disease duration
  • All patients had ≤1 relapse in the previous year
  • EDSS score 0-5.0 (mean: 2.3)
  • 37 years median age

aPlatform therapy with interferon-beta (IFNβ) and glatiramer acetate (GA). The remaining 6% did not receive these agents for ≥6 months before the study period.1

IMPACT ON KEY MEASURES OF DISEASE ACTIVITY OBSERVED IN THE AFFIRM TRIAL1,2

  • 17% of patients taking TYSABRI experienced disability progression vs 29% of patients taking placebo, representing a 42% relative risk reduction (HR: 0.58; p<0.001)

Mean T2 lesions

In patients taking TYSABRI, there was an 83% relative reduction in new or enlarging T2 lesions vs patients taking placebo (1.9 vs 11; p<0.001)

Mean Gd+ lesions

Patients taking TYSABRI had 92% fewer Gd+ lesions than patients taking placebo (0.1 vs 1.2; p<0.001)

EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; ARR=Annualized Relapse Rate.

Mean ARR

There was a 67% relative reduction in ARR with TYSABRI vs placebo (0.22 vs 0.67; p<0.001)

EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; ARR=Annualized Relapse Rate.

REAL EXPERIENCES WITH TYSABRI

Leading physicians recount personal experiences in treating patients with active disease who responded well to TYSABRI.