{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T01:07:22Z","timestamp":1790298442112,"version":"4.1.0"},"reference-count":65,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,6,23]],"date-time":"2017-06-23T00:00:00Z","timestamp":1498176000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Neurol Disord"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:p> Natalizumab, a monoclonal antibody that blocks lymphocyte infiltration in the central nervous system, is a valuable tool in the treatment of relapsing forms of multiple sclerosis (MS). In a phase III clinical trial comparing natalizumab with placebo over 2 years, natalizumab reduced annualized relapse rate by 68%, 12-week confirmed disability progression by 42%, and reduced contrast-enhancing lesions by 92%. In post hoc analyses, natalizumab treatment was associated with 37% of patients achieving no evidence of disease activity ( versus 7% on placebo) and 30% achieving sustained disability improvement ( versus 19% on placebo). Natalizumab did not achieve a statistically significant primary composite disability outcome in a trial of 887 patients with secondary progressive MS, but it did demonstrate a benefit on a prespecified component of the 9-Hole Peg Test. The greatest risk of natalizumab treatment is progressive multifocal leukoencephalopathy (PML), with a 23% mortality rate. Risk stratification on the basis of immunosuppressant exposure, natalizumab treatment duration and anti-John Cunningham virus (JCV) antibody status and index has greatly improved clinical decision making. Other potential serious natalizumab-associated risks reported in clinical trials and postmarketing settings include infusion reactions, hepatotoxicity and rare, serious opportunistic infections. With more than a decade of continuous postmarketing experience, natalizumab remains a very effective option for patients with relapsing forms of MS. To optimize appropriate selection of natalizumab for patients with relapsing MS, however, a thorough understanding of individual patient risk factors for PML or other adverse events is also required. <\/jats:p>","DOI":"10.1177\/1756285617716002","type":"journal-article","created":{"date-parts":[[2017,6,23]],"date-time":"2017-06-23T09:47:50Z","timestamp":1498211270000},"page":"327-336","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":49,"title":["The role of natalizumab in the treatment of multiple sclerosis: benefits and risks"],"prefix":"10.1177","volume":"10","author":[{"given":"Barry A.","family":"Singer","sequence":"first","affiliation":[{"name":"The MS Center for Innovations in Care, Missouri Baptist Medical Center, 3009 North Ballas Road, Suite 207B, St Louis, MO 63131, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,6,23]]},"reference":[{"key":"bibr1-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000158329.30470.D0"},{"key":"bibr2-1756285617716002","doi-asserted-by":"publisher","DOI":"10.3949\/ccjm.78.s2.05"},{"key":"bibr3-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044397"},{"key":"bibr4-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000260064.77700.fd"},{"key":"bibr5-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-014-0140-z"},{"key":"bibr6-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1111\/ene.13272"},{"key":"bibr7-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(09)70021-3"},{"key":"bibr8-1756285617716002","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1177\/1352458512450088","volume":"19","author":"Havrdova E","year":"2013","journal-title":"Mult Scler"},{"key":"bibr9-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1177\/1352458511399611"},{"key":"bibr10-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044396"},{"key":"bibr11-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051847"},{"key":"bibr12-1756285617716002","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051782"},{"key":"bibr13-1756285617716002","first-page":"e22","volume":"87","author":"Steiner D","year":"2016","journal-title":"Neurology"},{"key":"bibr14-1756285617716002","unstructured":"Biogen. 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