{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T21:19:45Z","timestamp":1792271985619,"version":"4.4.0"},"reference-count":29,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2011,1,12]],"date-time":"2011-01-12T00:00:00Z","timestamp":1294790400000},"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":["Mult Scler"],"published-print":{"date-parts":[[2011,6]]},"abstract":"<jats:p>Background: A post marketing surveillance study was conducted to evaluate safety and efficacy of natalizumab in Swedish multiple sclerosis (MS) patients since its introduction in August 2006 until March 2010.<\/jats:p>\n                  <jats:p>Methods: Patients were registered in the web-based Swedish MS-registry at 40 locations and evaluated every 6 months. Adverse events and clinical outcomes were recorded.<\/jats:p>\n                  <jats:p>Results: One thousand one hundred and fifty-two patients were included (71.4% female) and 149 patients stopped treatment; the main reason was planned pregnancy. Anti-natalizumab antibodies were found in 4.5% (52 patients) of which 1.6% displayed persistent antibodies. Serious adverse events were rare, but included three cases with progressive multifocal leukoencephalopathy (PML). There were seven fatal cases, probably unrelated to the natalizumab treatment. For relapsing\u2013remitting MS patients ( n\u2009=\u2009901), mean Expanded Disability Status Scale (EDSS, \u221210.7%), Multiple Sclerosis Severity Scale (MSSS, \u221220.4%), Multiple Sclerosis Impact Scale (MSIS-29, physical \u22129.9%, psychological \u221213.3%) and Symbol Digit Modalities Test (SDMT, +10.7%) all showed significant improvements during 24 months of treatment with natalizumab. The Swedish web-based MS quality registry proved to function as a platform for post-marketing MS drug surveillance, providing long-term data regarding drug effects and adverse events beyond clinical trials.<\/jats:p>\n                  <jats:p>Conclusions: Our results indicate that natalizumab is generally well tolerated and has sustained efficacy for patients with active MS, though the risk of PML is still an important concern.<\/jats:p>","DOI":"10.1177\/1352458510394701","type":"journal-article","created":{"date-parts":[[2011,1,12]],"date-time":"2011-01-12T20:57:00Z","timestamp":1294865820000},"page":"708-719","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":91,"title":["A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis"],"prefix":"10.1177","volume":"17","author":[{"given":"Carolina","family":"Holm\u00e9n","sequence":"first","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fredrik","family":"Piehl","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Hillert","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Fogdell-Hahn","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malin","family":"Lundkvist","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elin","family":"Karlberg","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Nilsson","sequence":"additional","affiliation":[{"name":"Sk\u00e5nes Universitetssjukhus, Department of Neurology Lund, Malm\u00f6, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Dahle","sequence":"additional","affiliation":[{"name":"Link\u00f6ping Universitetssjukhus, Department of Clinical and Experimental Medicine, Link\u00f6ping, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Feltelius","sequence":"additional","affiliation":[{"name":"Medical Products Agency, Department of Drug Safety, Uppsala, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Svenningsson","sequence":"additional","affiliation":[{"name":"Ume\u00e5 University, Department of Pharmacology and Clinical Neuroscience, Ume\u00e5, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Lycke","sequence":"additional","affiliation":[{"name":"The Sahlgrenska Academy University of Gothenburg, Institute of Neuroscience and Physiology, Gothenburg, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Olsson","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2011,1,12]]},"reference":[{"key":"bibr1-1352458510394701","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S5218"},{"key":"bibr2-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044397"},{"key":"bibr3-1352458510394701","unstructured":"US Food and Drug Administration.\n                      Drug Safety and Availability\n                      . http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ (Information on natalizumab \u2013 marketed as Tysabri.) Updated information: September 2009."},{"key":"bibr4-1352458510394701","unstructured":"Biogen Idec. Monthly Tysabri safety communication, May 2010, S."},{"key":"bibr5-1352458510394701","unstructured":"Swedish MS Association. Rekommendationer avseende behandling av MS med natalizumab (Tysabri). http:\/\/www.mssallskapet.se\/ October 2009 [In English: Swedish MS Association. Recommendations regarding treatment of MS with natalizumab (Tysabri). http:\/\/www.mssallskapet.se\/.]."},{"key":"bibr6-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000156155.19270.F8"},{"key":"bibr7-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1002\/ana.410360717"},{"key":"bibr8-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2005.064584"},{"key":"bibr9-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.73.6.701"},{"key":"bibr10-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1177\/1352458508090923"},{"key":"bibr11-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1177\/1352458506070750"},{"key":"bibr12-1352458510394701","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0002028"},{"key":"bibr13-1352458510394701","unstructured":"TYSABRI \u2013 The TOUCH Prescribing Program, http:\/\/www.tysabri.com\/tysbProject\/tysb.portal\/."},{"key":"bibr14-1352458510394701","doi-asserted-by":"crossref","unstructured":"Bezabeh S, Flowers CM, Kortepeter C and Avigan M. 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