{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T10:48:36Z","timestamp":1785408516296,"version":"3.56.0"},"reference-count":24,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Medical University of Silesia from teaching and research subsidy funds"},{"id":[{"id":"https:\/\/ror.org\/0104rcc94","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Real-world evidence on ofatumumab (OFA) beyond 12 months remains limited in relapsing\u2013remitting multiple sclerosis (RRMS). We assessed 24-month effectiveness and safety, compared treatment-na\u00efve and previously treated patients, and explored predictors of failure to achieve No Evidence of Disease Activity-3 (NEDA-3). Methods: This multicenter retrospective cohort study included adult RRMS patients treated with OFA in routine clinical practice. Effectiveness analyses were restricted to patients with complete 24-month follow-up and full clinical and magnetic resonance imaging (MRI) assessment (complete-case analysis). Outcomes included relapses, MRI activity, Expanded Disability Status Scale (EDSS) progression, NEDA-3, and adverse events (AEs). Exploratory multivariable logistic regression was used to assess baseline predictors of NEDA-3 non-achievement. Results: Of 258 patients who initiated OFA, 148 had completed 24-month clinical and MRI follow-up and were evaluable for effectiveness. Over 24 months, 71.5% achieved NEDA-3; relapses occurred in 15.5% of patients, MRI activity in 15.5%, gadolinium-enhancing lesions (GELs) in 4.7%, and EDSS progression in 17.6%. Disease activity was minimal during months 12\u201324, with relapses in 2.7%, MRI activity in 2.0%, and no GELs. In unadjusted analyses, no statistically significant differences were observed between treatment-na\u00efve and previously treated patients. Higher baseline EDSS was associated with failure to achieve NEDA-3. In the 24-month safety subgroup, AEs were recorded in 28.4% of patients; infections occurred in 26.4% of patients (all grade 1\u20132), and no serious adverse events were observed. Conclusions: In this multicenter real-world cohort, OFA was associated with low inflammatory disease activity over 24 months in RRMS patients with complete follow-up. These findings should be interpreted cautiously because the effectiveness analysis was restricted to a complete-case cohort and safety data were collected retrospectively.<\/jats:p>","DOI":"10.3390\/jcm15072585","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T15:45:42Z","timestamp":1774626342000},"page":"2585","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Twenty-Four-Month Real-World Outcomes of Ofatumumab in Relapsing\u2013Remitting Multiple Sclerosis: A Multicenter Retrospective Cohort Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6618-7013","authenticated-orcid":false,"given":"Weronika","family":"Galus","sequence":"first","affiliation":[{"name":"Department of Neurology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-752 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0152-2305","authenticated-orcid":false,"given":"Magdalena","family":"Kie\u0142bowicz-Ho\u0142ysz","sequence":"additional","affiliation":[{"name":"Department of Neurology with the Stroke Subunit Prof. K. Gibi\u0144ski University Clinical Centre, Medical University of Silesia in Katowice, 40-752 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0340-660X","authenticated-orcid":false,"given":"Joanna","family":"Siuda","sequence":"additional","affiliation":[{"name":"Department of Neurology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-752 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Gajewska","sequence":"additional","affiliation":[{"name":"Department of Neurology, Upper Silesian Medical Center, Medical University of Silesia, 40-635 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2481-7528","authenticated-orcid":false,"given":"Anetta","family":"Lasek-Bal","sequence":"additional","affiliation":[{"name":"Department of Neurology, Faculty of Health Sciences in Katowice, Medical University of Silesia, 40-635 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7787-5660","authenticated-orcid":false,"given":"Przemys\u0142aw","family":"Puz","sequence":"additional","affiliation":[{"name":"Department of Neurology, Faculty of Health Sciences in Katowice, Medical University of Silesia, 40-635 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"183","DOI":"10.1016\/S0140-6736(23)01473-3","article-title":"Multiple sclerosis","volume":"403","author":"Jakimovski","year":"2024","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"569","DOI":"10.5603\/pjnns.102356","article-title":"Disease-modifying therapy in multiple sclerosis: Recommendations of Multiple Sclerosis and Neuroimmunology Section of Polish Neurological Society","volume":"58","author":"Kalinowska","year":"2024","journal-title":"Neurol. Neurochir. Pol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1177\/1352458519892555","article-title":"Leveraging real-world data to investigate multiple sclerosis disease behavior, prognosis, and treatment","volume":"26","author":"Cohen","year":"2020","journal-title":"Mult. Scler. J."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"a032037","DOI":"10.1101\/cshperspect.a032037","article-title":"B-cell therapies in multiple sclerosis","volume":"9","author":"Sabatino","year":"2019","journal-title":"Cold Spring Harb. Perspect. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1056\/NEJMoa1917246","article-title":"Ofatumumab versus teriflunomide in multiple sclerosis","volume":"383","author":"Hauser","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1452","DOI":"10.1177\/13524585231195346","article-title":"Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension","volume":"29","author":"Hauser","year":"2023","journal-title":"Mult. Scler. J."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Galus, W., Kaczmarczyk, A., Walawska-Hrycek, A., Siuda, J., Polewka, M., Lasek-Bal, A., and Puz, P. (2025). Real-world data of first 12 months of ofatumumab treatment in multiple sclerosis patients: A multicenter experience from tertiary referral centers. Medicina, 61.","DOI":"10.3390\/medicina61091568"},{"key":"ref_8","unstructured":"Ministerstwo Zdrowia (2025, May 15). Programy Lekowe, Available online: https:\/\/www.gov.pl\/web\/zdrowie\/programy-lekowe."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1444","DOI":"10.1212\/WNL.33.11.1444","article-title":"Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS)","volume":"33","author":"Kurtzke","year":"1983","journal-title":"Neurology"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2313","DOI":"10.1007\/s40120-025-00818-7","article-title":"Real-world 24-month outcomes of ofatumumab in relapsing multiple sclerosis: Efficacy, safety, and the impact of frailty","volume":"14","author":"Ferrazzano","year":"2025","journal-title":"Neurol. Ther."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"106994","DOI":"10.1016\/j.msard.2026.106994","article-title":"Real-world effectiveness and safety of ofatumumab in relapsing multiple sclerosis: A multicenter cohort study","volume":"107","author":"Matovina","year":"2026","journal-title":"Mult. Scler. Relat. Disord."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1080\/17582024.2025.2452150","article-title":"Real-world effectiveness, persistence, tolerability, and safety of ofatumumab in clinical practice","volume":"15","author":"Amin","year":"2025","journal-title":"Neurodegener. Dis. Manag."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e00724","DOI":"10.1016\/j.neurot.2025.e00724","article-title":"Real-world effectiveness and safety of ofatumumab in relapsing-remitting multiple sclerosis: Insights from na\u00efve and switch patients","volume":"22","author":"Chisari","year":"2025","journal-title":"Neurotherapeutics"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"6080","DOI":"10.1007\/s00415-024-12581-0","article-title":"Quality of life and tolerability of B-cell directed therapy of multiple sclerosis with ofatumumab in a patient-centered real-world observational study","volume":"271","author":"Karl","year":"2024","journal-title":"J. Neurol."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"St\u0119pie\u0144, A., Pogoda-Weso\u0142owska, A., Staszewski, J., Brola, W., Kania, K., Krzystanek, E., Rusek, S., Zajdel, R., Ha\u0142as, M., and Karaszewski, B. (2025). Early treatment with ofatumumab increases the likelihood of stabilizing disease in patients with relapsing-remitting multiple sclerosis. Arch. Med. Sci., in press.","DOI":"10.5114\/aoms\/205112"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"106617","DOI":"10.1016\/j.msard.2025.106617","article-title":"Real-world change in annualized relapse rate and healthcare resource utilization following initiation of ofatumumab in people with multiple sclerosis","volume":"102","author":"Tai","year":"2025","journal-title":"Mult. Scler. Relat. Disord."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"4495","DOI":"10.1007\/s00415-024-12360-x","article-title":"Ocrelizumab and ofatumumab comparison: An Italian real-world propensity score matched study","volume":"271","author":"Borriello","year":"2024","journal-title":"J. Neurol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1002\/ana.27143","article-title":"Different Treatment Outcomes of Multiple Sclerosis Patients Receiving Ocrelizumab or Ofatumumab","volume":"97","author":"Meuth","year":"2025","journal-title":"Ann. Neurol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"105570","DOI":"10.1016\/j.msard.2024.105570","article-title":"Efficacy and Safety of Ocrelizumab in Patients with Relapsing Multiple Sclerosis: Real-World Experience of Two Swiss Multiple Sclerosis Centers","volume":"86","author":"Diem","year":"2024","journal-title":"Mult. Scler. Relat. Disord."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"3951","DOI":"10.1007\/s10072-024-07449-0","article-title":"Ocrelizumab Use in Multiple Sclerosis: A Real-World Experience in a Changing Therapeutic Scenario","volume":"45","author":"Lorefice","year":"2024","journal-title":"Neurol. Sci."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"106885","DOI":"10.1016\/j.msard.2025.106885","article-title":"Real-World Effectiveness of Ocrelizumab in Relapsing Multiple Sclerosis: An MSBase Registry Sub-Study","volume":"106","author":"Butzkueven","year":"2026","journal-title":"Mult. Scler. Relat. Disord."},{"key":"ref_22","first-page":"2055217320973049","article-title":"Safety and Efficacy of Rituximab as First- and Second Line Treatment in Multiple Sclerosis\u2014A Cohort Study","volume":"7","author":"Torgauten","year":"2021","journal-title":"Mult. Scler. J. Exp. Transl. Clin."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"789","DOI":"10.1001\/jamaneurol.2023.1625","article-title":"Rituximab vs Ocrelizumab in Relapsing-Remitting Multiple Sclerosis","volume":"80","author":"Roos","year":"2023","journal-title":"JAMA Neurol."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Chen, H. (2025). Real-world pharmacovigilance of ofatumumab in multiple sclerosis: A comprehensive FAERS data analysis. Front. Pharmacol., 15.","DOI":"10.3389\/fphar.2024.1521726"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/7\/2585\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T16:06:27Z","timestamp":1775059587000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/7\/2585"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,27]]},"references-count":24,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2026,4]]}},"alternative-id":["jcm15072585"],"URL":"https:\/\/doi.org\/10.3390\/jcm15072585","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,27]]}}}