{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T20:43:58Z","timestamp":1775853838064,"version":"3.50.1"},"reference-count":47,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"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":["Ther Adv Neurol Disord"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Despite the availability of several disease-modifying therapies for multiple sclerosis (MS) patients, the optimal strategy remains debated. High-efficacy therapies may better prevent subclinical disease activity and long-term disability; however, escalation remains frequent in real-world practice. Ofatumumab, an anti-CD20 monoclonal antibody, demonstrated robust efficacy and safety in clinical trials; however, real-world data are also essential.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate the effectiveness and safety of ofatumumab in relapsing MS (RMS), comparing outcomes between treatment-na\u00efve and previously treated patients, and identify predictors of suboptimal response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Prospective longitudinal observational study of RMS patients followed at the Verona MS Center.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Clinical assessments, annual 3.0T brain MRI, and comprehensive neuropsychological testing were performed throughout follow-up. Treatment effectiveness was evaluated using no evidence of disease activity (NEDA), progression independent of relapse activity (PIRA), and cognitive PIRA. Safety was assessed by recording adverse events and treatment discontinuations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Eighty-nine RMS patients (68.5% female, mean age 38.0\u2009\u00b1\u200910.4\u2009years) were followed for a mean of 3\u2009years. Overall, 91% achieved NEDA-3, with one relapse and one case of MRI activity. Seven patients (7.9%) developed PIRA, six of whom also fulfilled criteria for cognitive PIRA. Among 46 NEDA-3 patients who underwent longitudinal cognitive assessment, 37 (80.4%) did not exhibit cognitive worsening during follow-up and were classified as NEDA-4, indicating stability across clinical, radiological, and cognitive domains. In general, among patients with longitudinal cognitive data, 37 of 54 (68.5%) were NEDA-4. Na\u00efve and previously treated patients showed comparable outcomes. Patients who failed to maintain NEDA-3 were older and had higher baseline disability, whereas in multivariable analyses, baseline Expanded Disability Status Scale (EDSS) was the only factor independently associated with NEDA-3 loss. When cognitive outcomes were included, associations between baseline clinical variables and NEDA-4 loss were attenuated. Ofatumumab was well-tolerated, with mostly mild transient injection-related reactions and 2 (2.2%) treatment discontinuations due to adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Ofatumumab provided sustained multidimensional disease control, high NEDA-4 rates, and excellent tolerability. Baseline EDSS was the primary predictor of suboptimal response, underscoring the importance of early intervention. These findings support early anti-CD20 therapy as an effective strategy to preserve neurological function and limit long-term progression.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562864261434351","type":"journal-article","created":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T12:34:39Z","timestamp":1775565279000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world effectiveness and safety of ofatumumab in multiple sclerosis: a longitudinal study integrating clinical, cognitive, and MRI outcomes"],"prefix":"10.1177","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0426-7223","authenticated-orcid":false,"given":"Stefano","family":"Ziccardi","sequence":"first","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Damiano","family":"Marastoni","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pietro","family":"Biasi","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agnese","family":"Tamanti","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca Benedetta","family":"Pizzini","sequence":"additional","affiliation":[{"name":"Neuroradiology Unit, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milena","family":"Calderone","sequence":"additional","affiliation":[{"name":"Radiology Unit, CMSR Veneto Medica, Altavilla Vicentina, Vicenza, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valentina","family":"Camera","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maddalena","family":"Bertolazzo","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice","family":"Daldosso","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bianca","family":"Milocco","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberta","family":"Magliozzi","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy"},{"name":"Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Massimiliano","family":"Calabrese","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center of the University Hospital of Verona, Neurology Section, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico G. 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