Relapsing MS patients received 300 mg TYSABRI IV every 28 days (n=627) or placebo (n=315). Patients with PPMS, SPMS, and PRMS were excluded.
83% of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with placebo (primary endpoint: 17% vs 29%; p<0.001)1,2
TYSABRI demonstrated 67% relative reduction in ARR vs placebo (secondary endpoint: 0.22 vs 0.67; p<0.001)1,2
TYSABRI was further studied in the ongoing TOP study. The 10-year interim results found:
Study description: TOP is an ongoing, open-label, multinational, observational, 10-year prospective study with planned continued follow-up for up to 15 years, assessing the long-term safety and efficacy of TYSABRI in 6148 patients with relapsing MS in clinical practice. Eligible RRMS patients met criteria for a TYSABRI prescription in their respective countries and had 3 or fewer TYSABRI infusions before enrollment in the TOP study. Patients receive TYSABRI 300 mg intravenously every 4 weeks.3,4
Incidence rates for OI, malignancy, and PML were low (~1%) and were similar during the first 3 years on treatment and beyond, as indicated by overlapping confidence intervals.
Adapted from Kappos et al. ECTRIMS poster P908. Oct. 10-12, 2018. Berlin, Germany.
RRMS=relapsing-remitting multiple sclerosis; SAE=serious adverse event; OI=opportunistic infection; DMT=disease-modifying therapy; ARR=annualized relapse rate; EDSS=Expanded Disability Status Scale; CI=confidence interval.
aEach patient was counted only once within each preferred term. Multiple sclerosis was also reported as an SAE in 15 patients.3
bARRs for the year prior to starting natalizumab and the period during which patients were on natalizumab (and ≤84 days after the last dose) were compared using a repeated Poisson model.3
cCumulative probability of confirmed disability worsening was defined as an increase of ≥1.5 from a baseline score of 0.0, ≥1.0 from a score of 1.0–5.5, or ≥0.5 from a score ≥6.0, sustained for 24 weeks.3