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: Vincent van Pesch, Christian J Sindic, Oscar Fernández
• Journal: Clinical neurology and neurosurgery (Clin Neurol Neurosurg) Vol. 149 Pg. 55-63 (Oct 2016) ISSN: 1872-6968 [Electronic] Netherlands
• PMID: 27475049 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2016 Elsevier B.V. All rights reserved.

Chemical References

• Immunologic Factors
• Natalizumab

Topics

• Humans
• Immunologic Factors (adverse effects, pharmacology)
• Multiple Sclerosis, Relapsing-Remitting (drug therapy)
• Natalizumab (adverse effects, pharmacology)
• Observational Studies as Topic (statistics & numerical data)
• Outcome Assessment, Health Care (statistics & numerical data)