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). 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.1-3

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

Impact on key measures of disease activity observed in the AFFIRM trial
Impact on key measures of disease activity observed in the AFFIRM trial
Secondary Endpoint

  • 67% relative reduction in ARR at 2 years with TYSABRI (n=627) vs placebo (n=315) (0.22 vs 0.67; p<0.001)1,2

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

REAL EXPERIENCES WITH TYSABRI

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

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

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