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