{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:18:13Z","timestamp":1791908293384,"version":"4.3.4"},"reference-count":30,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100008792","name":"novartis pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit\u2013risk profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients completing ASCLEPIOS I\/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5\u2009months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3\u2009months, 986 patient-years). A total of 1650 patients (83.8%) had \u2a7e1 adverse events and 191 (9.7%) had \u2a7e1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In patients with up to 3.5\u2009years\u2019 exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit\u2013risk profile of ofatumumab in RMS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585221079731","type":"journal-article","created":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T06:52:31Z","timestamp":1646117551000},"page":"1576-1590","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":79,"title":["Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5\u2009years"],"prefix":"10.1177","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4932-4001","authenticated-orcid":false,"given":"Stephen L","family":"Hauser","sequence":"first","affiliation":[{"name":"UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0829-7569","authenticated-orcid":false,"given":"Anne H","family":"Cross","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Winthrop","sequence":"additional","affiliation":[{"name":"Oregon Health &amp; Sciences University, Portland, OR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4310-3432","authenticated-orcid":false,"given":"Heinz","family":"Wiendl","sequence":"additional","affiliation":[{"name":"Department of Neurology with Institute of Translational Neurology, University of M\u00fcnster, M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Nicholas","sequence":"additional","affiliation":[{"name":"OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven G","family":"Meuth","sequence":"additional","affiliation":[{"name":"Department of Neurology, University Hospital D\u00fcsseldorf, D\u00fcsseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1346-3042","authenticated-orcid":false,"given":"Paul S","family":"Giacomini","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1323-6317","authenticated-orcid":false,"given":"Francesco","family":"Sacc\u00e0","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Mancione","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"Zielman","sequence":"additional","affiliation":[{"name":"Novartis Pharma BV, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Bagger","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayan","family":"Das Gupta","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt. 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