Abstract
INTRODUCTION: Tysabri (natalizumab) is a recombinant humanized IgG4 monoclonal antibody for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). A subcutaneous (SC) formulation administered by healthcare professionals (HCPs) is expected to save time for patients and healthcare staff compared with intravenous (IV) delivery. This observational study quantifies HCP and patient time with natalizumab IV vs natalizumab SC in patients with RRMS. METHODS: Seven sites across France (n = 3), Spain (n = 3), and the United Kingdom (UK) (n = 1) participated in this study. Primary endpoints were active HCP time for tasks related to preparation and administration processes of natalizumab, all tasks combined, and time in the infusion chair. The target sample was 15 observations each of natalizumab IV and SC per site. Results were extrapolated per patient per year. HCP satisfaction and preference were assessed via a one-time survey. RESULTS: A total of 213 observations were collected (102 IV and 111 SC). Mean total active HCP time (min) per visit (and annually) was 15.8 (205.8) for IV and 9.1 (118.4) for SC (- 42.5% [pooled], - 29.3% [Spain], - 48.1% [France], and - 56.5% [UK]). Mean time in the infusion chair (min) was 95.2 for IV and 33.5 for SC (- 64.9% [pooled], - 60.4% [Spain], - 67.3% [France], and - 69.2% [UK]). Mean HCP satisfaction score for administration was higher for SC than for IV (9.2 vs 8.2; p = 0.026). Seventy percent of HCPs stated a preference for SC, of which 56.3% stated a very strong and 18.8% a fairly strong preference. CONCLUSIONS: Natalizumab SC offers substantial savings in active HCP time and patient chair time compared with natalizumab IV. HCPs reported higher satisfaction and a preference for natalizumab SC. The HCP time and infusion chair capacity made available with natalizumab SC could be reallocated to other patient-care activities or used to treat additional patients, thereby improving overall healthcare efficiency.