Journal article

Clinical outcomes in patients who discontinue natalizumab therapy after 2 years in the Tysabri(R) Observational Program (TOP)

Helmut Butzkueven, Maria Trojano, Ludwig Kappos, Tim Spelman, Heinz Wiendl, Karen Rosales, Ray Su, Stephanie Licata, Pei-Ran Ho, Nolan Campbell

Multiple Sclerosis Journal | SAGE PUBLICATIONS LTD | Published : 2020


BACKGROUND: Natalizumab is a highly efficacious therapy for relapsing-remitting multiple sclerosis (RRMS). Patients who discontinue natalizumab may experience return of MS disease activity. OBJECTIVE: The aim of this study was to analyze predictors of post-natalizumab disease activity return. METHODS: The Tysabri® Observational Program (TOP) is an ongoing observational study of natalizumab-treated RRMS patients. Patients discontinuing natalizumab are encouraged to remain in TOP. RESULTS: Analyses included 3221 TOP patients. After ⩾2 years on natalizumab, relapse risk was twice as high for patients who switched to an oral therapy (n = 660, hazard ratio (HR) = 2.18, p < 0.001) and three times ..

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