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
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..View full abstract
This study was supported by Biogen. Biogen also provided funding for medical writing support in development of this manuscript. Biogen reviewed the manuscript and provided feedback to the authors. The authors provided their final approval of all content.