title: Effectiveness and safety of natalizumab in real-world clinical practice: Review of observational studies.
abstract: Clinical trials have shown that natalizumab is highly effective for treating relapsing forms of multiple sclerosis (MS). The purpose of this analysis was to conduct a targeted review of data from country-specific observational studies and registries of natalizumab-treated patients with relapsing MS in order to more fully investigate the longer-term effectiveness and safety of this disease-modifying therapy in real-world clinical practice settings. A PubMed search was conducted on March 13, 2014, using the terms (natalizumab AND multiple sclerosis) AND (observational OR registry OR post-marketing OR clinical practice). Only English-language papers that reported effectiveness (in terms of effects on relapses, disability progression, and magnetic resonance imaging findings) and/or safety results from studies were included. Data from 22 studies/registries were included. Annualized relapse rates decreased by 73%-94% from baseline across the studies, with improvement maintained for up to 5 years during natalizumab treatment. Natalizumab effectiveness was also demonstrated via assessment of disability progression (Expanded Disability Status Scale), radiological measures, and no-evidence-of-disease-activity measures (clinical, radiological, and overall). Results were similar among patient groups stratified by level of disease activity. Safety outcomes were consistent with natalizumab's known safety profile. Data from country-specific observational studies and registries varying in size and scope support the effectiveness and safety of natalizumab in a broad range of patients in clinical practice.
authors.affiliation: Department of Neurology, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium. Electronic address: vincent.vanpesch@uclouvain.be.
authors.forename: Vincent
authors.initials: V
authors.lastname: van Pesch
authors.affiliation: Department of Neurology, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium. Electronic address: csindic.neuro@gmail.com.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Sindic
authors.affiliation: Institute of Clinical Neurosciences, Hospital Regional Universitario, Málaga, IBIMA, University of Málaga, Spain. Electronic address: oscar.fernandez.sspa@gmail.com.
authors.forename: Oscar
authors.initials: O
authors.lastname: Fernández
mesh_terms: D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000494:pharmacology*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000069442:Natalizumab / Q000009:adverse effects / Q000494:pharmacology*; D064887:Observational Studies as Topic / Q000706:statistics & numerical data*; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*
chemical_list: D007155:Immunologic Factors; D000069442:Natalizumab
keywords: Effectiveness; Multiple sclerosis; Natalizumab; Observational study; Real-world; Safety