{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:30:56Z","timestamp":1791725456919,"version":"4.3.4"},"reference-count":26,"publisher":"SAGE Publications","issue":"11-12","license":[{"start":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T00:00:00Z","timestamp":1694390400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5\u2009years versus teriflunomide in relapsing multiple sclerosis (RMS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Further characterize efficacy and safety of ofatumumab in RMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Efficacy set: patients randomized to ofatumumab\/teriflunomide in ASCLEPIOS I\/II (core). Safety set: patients who received\u2009\u2a7e\u20091 dose of ofatumumab in ASCLEPIOS I\/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide. Data cut-off: 25 September 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>In the efficacy set ( n\u2009=\u20091882), the continuous ofatumumab group had a low annualized relapse rate (ARR 0.05 (95% confidence interval: 0.04\u20130.07)), low numbers of gadolinium-enhancing (Gd+) T1 lesions (0.01 lesions\/scan) and fewer new\/enlarging T2 lesions (annualized rate 0.08). Overall, 78.8% met three-parameter \u201cno evidence of disease activity\u201d criteria through 4\u2009years. Switching from teriflunomide led to reduced ARR, risk of confirmed disability worsening (CDW), new\/enlarging T2 lesions, Gd+\u2009T1 lesions, and serum neurofilament light chain. In the continuous and newly switched ofatumumab groups, cumulative 3- and 6-month CDW rates remained low. In the safety set ( n\u2009=\u20091969), the most frequently reported adverse events were infections and infestations (58.35%). No new safety signals were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Ofatumumab has a favorable longer-term benefit\u2013risk profile in RMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registry:<\/jats:title>\n                    <jats:p>ALITHIOS (NCT03650114): https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03650114<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585231195346","type":"journal-article","created":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T03:15:30Z","timestamp":1694402130000},"page":"1452-1464","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":61,"title":["Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension"],"prefix":"10.1177","volume":"29","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 and Department of Neurology, University of California, San Francisco (UCSF), 1651 4th Street, Box 3126, San Francisco, CA 94143, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"Zielman","sequence":"additional","affiliation":[{"name":"Clinical Development, Novartis Pharma B.V., Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayan","family":"Das Gupta","sequence":"additional","affiliation":[{"name":"Analytics, Novartis Healthcare Pvt. Ltd., Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xi","sequence":"additional","affiliation":[{"name":"China Novartis Institutes for Biomedical Research Co. Ltd., Novartis, Shanghai, People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dee","family":"Stoneman","sequence":"additional","affiliation":[{"name":"Global Medical, Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Goeril","family":"Karlsson","sequence":"additional","affiliation":[{"name":"Global Medical, Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derrick","family":"Robertson","sequence":"additional","affiliation":[{"name":"Department of Neurology, Multiple Sclerosis Division, Morsani College of Medicine, University of South Florida, Tampa, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9245-9772","authenticated-orcid":false,"given":"Jeffrey A","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Mellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4175-5509","authenticated-orcid":false,"given":"Ludwig","family":"Kappos","sequence":"additional","affiliation":[{"name":"MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Department of Head, Spine and Neuromedicine, Biomedical and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,9,11]]},"reference":[{"key":"bibr1-13524585231195346","unstructured":"US Food and Drug Administration. KESIMPTA\u00ae (ofatumumab) prescribing information, https:\/\/www.novartis.us\/sites\/www.novartis.us\/files\/kesimpta.pdf (accessed April 2022)."},{"key":"bibr2-13524585231195346","unstructured":"European Medicines Agency. Kesimpta SmPC, https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/kesimpta-epar-product-information_en.pdf. (accessed April 2022)."},{"key":"bibr3-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-021-00895-w"},{"key":"bibr4-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1917246"},{"key":"bibr5-13524585231195346","unstructured":"Novartis Press Release. FDA approves Novartis Kesimpta\u00ae (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis, https:\/\/www.novartis.com\/news\/media-releases\/fda-approves-novartis-kesimpta-ofatumumab-first-and-only-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis (accessed March 2023)."},{"key":"bibr6-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1177\/13524585211044479"},{"key":"bibr7-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1177\/13524585211055934"},{"key":"bibr8-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1177\/13524585221079731"},{"key":"bibr9-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.4905"},{"key":"bibr10-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30067-3"},{"key":"bibr11-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1177\/17562864211019574"},{"key":"bibr12-13524585231195346","doi-asserted-by":"publisher","DOI":"10.1177\/13524585221078825"},{"key":"bibr13-13524585231195346","unstructured":"US Department of Health and Human Services. 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