دورية أكاديمية

Effectiveness and safety of natalizumab in real-world clinical practice: Review of observational studies.

التفاصيل البيبلوغرافية
العنوان: Effectiveness and safety of natalizumab in real-world clinical practice: Review of observational studies.
المؤلفون: Van Pesch, Vincent, Sindic, Christian, Fernández, Oscar
المساهمون: UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie
المصدر: Clinical Neurology and Neurosurgery, Vol. 149, p. 55-63 (2016)
بيانات النشر: Elsevier BV
سنة النشر: 2016
المجموعة: DIAL@UCL (Université catholique de Louvain)
مصطلحات موضوعية: Effectiveness, Multiple sclerosis, Natalizumab, Observational study, Real-world, Safety
الوصف: 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.
نوع الوثيقة: article in journal/newspaper
اللغة: English
تدمد: 0303-8467
1872-6968
العلاقة: boreal:177587; http://hdl.handle.net/2078.1/177587Test; info:pmid/27475049; urn:ISSN:0303-8467; urn:EISSN:1872-6968
DOI: 10.1016/j.clineuro.2016.07.001
الإتاحة: https://doi.org/10.1016/j.clineuro.2016.07.001Test
http://hdl.handle.net/2078.1/177587Test
حقوق: info:eu-repo/semantics/restrictedAccess
رقم الانضمام: edsbas.3265AF44
قاعدة البيانات: BASE
الوصف
تدمد:03038467
18726968
DOI:10.1016/j.clineuro.2016.07.001