{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T14:05:18Z","timestamp":1792591518686,"version":"4.5.0"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,3,15]],"date-time":"2025-03-15T00:00:00Z","timestamp":1741996800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006546","name":"Angelini Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006546","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Cenobamate is an antiseizure medication (ASM) with a dual mechanism of action that was recently approved for the treatment of focal seizures in adults. This analysis aimed to describe the outcomes at 12 and 24\u2009weeks after starting cenobamate therapy in a real\u2010world setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>BLESS [NCT05859854] is an ongoing, observational, retrospective and prospective cohort study to evaluate the real\u2010world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Subgroup analysis was performed in subjects with 2 to 3 previous ASMs (early users) and those with &gt;3 previous ASMs (late users).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The second interim analysis of the BLESS study included 388 participants with a median (interquartile range) age of 43.0 (31.0\u201354.0) years. They had a median of 6.0 (4.0\u20139.0) prior ASMs and a median of 7.2 (3.0\u201320.6) monthly seizures at baseline. The median monthly seizure frequency was reduced by 59.9% (19.2%\u201387.3%) from baseline to 24\u2009weeks; 229 (59.0%) subjects had a \u226550% seizure frequency reduction, and 44 (11.3%) showed sustained seizure freedom. The proportion of participants taking \u22642 concomitant ASMs increased from 217 (56.5%) at baseline to 239 (65.7%) at 24\u2009weeks. Among the early users (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200976, 19.6%), the median reduction in monthly seizure frequency at 24\u2009weeks was 78.0% (50.0\u201397.1%), and 76.3% of subjects had a \u226550% response rate. The frequency of adverse drug reactions (ADRs) was 5.3% and 23.4% in early and late users. The most frequent ADRs were somnolence, dizziness, and balance disorder; after the occurrence of ADRs, 63.5% of participants maintained the prescribed dose, and 5.2% permanently discontinued treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>Cenobamate was effective in reducing seizure frequency in a real\u2010world setting and showed a manageable safety profile. The treatment with cenobamate also reduced the burden of concomitant ASMs in both early and late users.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/epi.18357","type":"journal-article","created":{"date-parts":[[2025,3,15]],"date-time":"2025-03-15T09:53:36Z","timestamp":1742032416000},"page":"2239-2252","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Effectiveness and safety of adjunctive cenobamate in people with focal\u2010onset epilepsy: Interim results after 24\u2010week observational period from the\n                    <scp>BLESS<\/scp>\n                    study"],"prefix":"10.1111","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8748-0083","authenticated-orcid":false,"given":"Simona","family":"Lattanzi","sequence":"first","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Neurological Clinic Marche Polytechnic University  Ancona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fedele","family":"Dono","sequence":"additional","affiliation":[{"name":"CAST, Center for Advanced Studies and Technology ITAB, Institute for Advanced Biomedical Technologies, Department of Neuroscience, Imaging, and Clinical Science University \u201cG. d'Annunzio\u201d Chieti\u2010Pescara  Chieti Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"d'Orsi","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Casa Sollievo della Sofferenza\u2010UOC Neurologia  San Giovanni Rotondo (FG) Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"D'Aniello","sequence":"additional","affiliation":[{"name":"IRCCS Neuromed  Pozzilli (IS) Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariangela","family":"Panebianco","sequence":"additional","affiliation":[{"name":"ARNAS Garibaldi\u2010UOC Neurologia  Catania Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Bonanni","sequence":"additional","affiliation":[{"name":"IRCCS E. 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