{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T11:40:55Z","timestamp":1792669255759,"version":"4.5.0"},"reference-count":32,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T00:00:00Z","timestamp":1783123200000},"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":["Mult Scler"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>In multiple sclerosis (MS), real-world evidence supports early intensive treatment (EIT) with high-efficacy therapies (HET) over escalation (ESC), although comparative data on long-term safety across sequences remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To compare the incidence of infections and neoplasms in patients treated with different treatment sequences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Data were extracted from the Italian MS and Related Disorders Register. DMTs were classified as moderate-efficacy treatment (MET), continuous HET (C-HET) or pulsed HET (P-HET). Six therapeutic sequences were reconstructed: MET-only, C-HET-only, P-HET-only, MET\u2192C-HET, MET\u2192P-HET and P-HET\u2192MET. Incidence rates (IRs; per 1000 person-years) and incidence rate ratios (IRRs) were estimated using multivariable Poisson regression, adjusting for age, sex, Expanded Disability Status Scale (EDSS), disease duration, MS phenotype and prior relapse activity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 37,375 patients were included in the analysis, with a median duration of treatment exposure of 8.8\u2009years. Infection risk was significantly higher with C-HET-only (IR, 24.82; IRR, 3.12), P-HET-only (IR, 13.43; IRR, 1.69), MET\u2192C-HET (IR, 10.46; IRR, 1.32) and MET\u2192P-HET (IR, 12.30; IRR, 1.55) versus MET-only (IR, 7.94), while P-HET\u2192MET showed no significant difference from MET-only (IR, 7.67; IRR, 0.97). Regarding neoplasm incidence, P-HET-only showed the lowest rates (IR, 0.18; IRR, 0.24), whereas it was significantly higher in C-HET-only (IR, 1.33; IRR, 1.79) and MET\u2192C-HET (IR, 1.01; IRR, 1.36) versus MET-only (IR, 0.74).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This is the first real-world study to compare the safety of different sequences in a national registry. ESC strategies did not confer a long-term safety advantage over EIT. Among HET regimens, C-HET was associated with the greatest risk of both serious infections and neoplasms, whereas P-HET showed the lowest neoplasm incidence.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585261457317","type":"journal-article","created":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T12:29:00Z","timestamp":1783168140000},"page":"1278-1291","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Profiling the long-term risk of severe adverse events in a cohort of multiple sclerosis patients treated with different treatment sequences: Results from the Italian Multiple Sclerosis and Related Disorders Registry (I-MS&amp;RD) (ProSA study)"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8645-1763","authenticated-orcid":false,"given":"Damiano","family":"Paolicelli","sequence":"first","affiliation":[{"name":"U.O.C. Neurologia L. Amaducci, A.O.U. Policlinico di Bari, Bari, Italy; Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Lucisano","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy; Center for Outcomes Research and Clinical Epidemiology \u2013 CORESEARCH SRL, Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Manni","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy; Neurological Department, A. Perrino\u2019s Hospital, Brindisi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2308-1731","authenticated-orcid":false,"given":"Pietro","family":"Iaffaldano","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4381-4613","authenticated-orcid":false,"given":"Marta","family":"Simone","sequence":"additional","affiliation":[{"name":"Child Neuropsychiatry Unit, Department of Precision and Regenerative Medicine, Jonic Area University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Iaffaldano","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommaso","family":"Guerra","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Mangialardi","sequence":"additional","affiliation":[{"name":"Department of Translational Biomedicine and Neurosciences, University of Bari \u2018Aldo Moro\u2019, Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6923-0846","authenticated-orcid":false,"given":"Francesco","family":"Patti","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Mediche e Chirurgiche e Tecnologie Avanzate, GF Ingrassia, University of Catania, Catania, Italy; UOS Sclerosi Multipla, AOU Policlinico \u2018G Rodolico \u2013 San Marco\u2019, Universit\u00e0 di Catania, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3878-8820","authenticated-orcid":false,"given":"Eleonora","family":"Cocco","sequence":"additional","affiliation":[{"name":"Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanna","family":"De Luca","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Centre, Neurology Unit, University Hospital Policlinico SS Annunziata, University G. 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