Journal article

Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP)

Helmut Butzkueven, Ludwig Kappos, Heinz Wiendl, Maria Trojano, Tim Spelman, Ih Chang, Rachna Kasliwal, Seema Jaitly, Nolan Campbell, Pei-Ran Ho, Stephanie Licata

JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY | BMJ PUBLISHING GROUP | Published : 2020

Abstract

OBJECTIVE: The Tysabri Observational Programme (TOP), which began >10 years ago, is an open-label, multinational, prospective observational study evaluating the long-term safety and effectiveness of natalizumab in relapsing-remitting multiple sclerosis patients. METHODS: These data provide a 10-year interim analysis of safety and effectiveness in TOP. Annualised relapse rates (ARRs) and disability progression/improvement were analysed using the Poisson model and the Kaplan-Meier method, respectively. Analyses included patients on natalizumab and those who discontinued natalizumab but remained in TOP. RESULTS: As of November 2017, TOP included 6148 patients. Overall, 829 patients (13.5%) expe..

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