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Ofatumumab demonstrated superior efficacy and tolerable safety in the phase 3 ASCLEPIOS trials, although few participants (\u2264\u20095%) transitioned from oral DMTs. ARTIOS evaluated the efficacy and safety of ofatumumab in adults with RMS switching from fingolimod or fumarates following breakthrough disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ARTIOS was a phase 3b, open-label, single-arm, multicenter, noncomparative study. Primary endpoint was annualized relapse rate (ARR); secondary endpoint was safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>562 adults on fingolimod (n\u2009=\u2009181) or fumarates (n\u2009=\u2009381) with breakthrough disease, defined as\u2009\u2265\u20091 relapse in prior year or\u2009\u2265\u20092 relapses in prior 2\u00a0years and\/or magnetic resonance imaging (MRI) evidence of disease activity in prior year, were enrolled. The primary endpoint was met, with a low ARR overall (0.06; 95% CI: 0.05\u20130.08; p\u2009&lt;\u20090.0001) and by prior DMT (fingolimod: 0.09; 95% CI: 0.06\u20130.1; fumarates: 0.06; 95% CI: 0.04\u20130.08), despite greater baseline disease severity with fingolimod. Ofatumumab resulted in near-complete suppression of MRI lesions, and 90.9% of participants achieved no evidence of disease activity, regardless of prior DMT. Six-month confirmed disability worsening occurred in few participants (7.3%). Safety outcomes were consistent with those of prior studies; most treatment-emergent adverse events (TEAEs) were mild to moderate, serious TEAEs were uncommon (5.9%), and rates of treatment discontinuations and interruptions were low.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ARTIOS complements the ASCLEPIOS studies and supports ofatumumab following switch from oral DMTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov, NCT04353492; April 20, 2020.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00415-026-13960-5","type":"journal-article","created":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T14:24:17Z","timestamp":1782743057000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of ofatumumab in participants with relapsing multiple sclerosis and breakthrough disease on oral fingolimod or fumarates: results from the ARTIOS study"],"prefix":"10.1007","volume":"273","clinical-trial-number":[{"clinical-trial-number":"nct04353492","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Riley","family":"Bove","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn","family":"Langdon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Maciejowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"El\u017cbieta","family":"Jasi\u0144ska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michal","family":"Dufek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anil","family":"Abeyewickreme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anamaria","family":"Rauh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haoyi","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imran Ali","family":"Khan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"B\u00f6hringer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara Madueno","family":"Eichau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Derfuss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,29]]},"reference":[{"issue":"6","key":"13960_CR1","doi-asserted-by":"publisher","first-page":"3116","DOI":"10.1007\/s00415-024-12305-4","volume":"271","author":"BA Singer","year":"2024","unstructured":"Singer BA, Feng J, Chiong-Rivero H (2024) Early use of high-efficacy therapies in multiple sclerosis in the United States: benefits, barriers, and strategies for encouraging adoption. 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Dawn Langdon has participated in speakers bureaus for Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva; has received consultancy fees from Bayer, Biogen, Merck, Novartis, and Teva; and has received research grants from Bayer, Biogen, Merck, and Novartis. Maciej Maciejowski has received compensation for lectures and\/or advisory board participation from Roche, Biogen, Novartis, Bristol Myers Squibb, and Amgen. El\u017cbieta Jasi\u0144ska has participated in speakers bureaus for Novartis, Neuraxpharm, and Sanofi Genzyme; and served on advisory boards and\/or steering committees of Novartis and Biogen. Sara Madueno Eichau has received speaker honoraria and consultant fees from Biogen, Merck, Neuraxpharm, Novartis, Almirall, Roche, Sanofi, and Teva. Tobias Derfuss\u2019s institution has received compensation from Actelion, Amgen, Alexion, Biogen, Celgene, GeNeuro, Janssen, Johnson & Johnson, Novartis, Roche, MedDay, Merck, Sanofi, and Polyneuron; and research grants from Alexion, Roche, and Biogen. An immediate family member of Tobias Derfuss has been an employee of Novartis and Roche. Anil Abeyewickreme, Anamaria Rauh, Haoyi Fu, and Imran Ali Khan are employees of Novartis. Michal Dufek and Matthias B\u00f6hringer have declared no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The protocol was reviewed and approved by an Institutional Review Board\/Independent Ethics Committee at each participating site in accordance with the Declaration of Helsinki and Council for International Organizations of Medical Sciences international ethical guidelines, applicable ICH Good Clinical Practice guidelines, and all applicable laws and regulations. The study was registered on ClinicalTrials.gov (NCT04353492).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All participants provided written informed consent prior to study participation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}],"article-number":"434"}}