{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T12:29:01Z","timestamp":1793363341257,"version":"4.5.0"},"reference-count":44,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Neurol"],"published-print":{"date-parts":[[2026,2,1]]},"abstract":"\n Importance<\/jats:title>\n \n Approximately 2% of amyotrophic lateral sclerosis (ALS) cases are attributable to a pathogenic variant in the superoxide dismutase 1 (\n SOD1<\/jats:italic>\n ) gene. Tofersen, an intrathecal antisense oligonucleotide designed to reduce SOD1 protein synthesis, is the first and only approved therapy for the treatment of ALS in adults who have a variant in the\n SOD1<\/jats:italic>\n gene.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To evaluate the long-term effects of tofersen in adults with\n SOD1<\/jats:italic>\n -ALS.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n The phase 3, randomized, double-blind, placebo-controlled VALOR trial (A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tofersen in\n SOD1<\/jats:italic>\n -ALS; conducted from March 2019 to July 2021) evaluated tofersen use over 28 weeks in adults (18 years and older) with weaknesses attributable to ALS and a confirmed\n SOD1<\/jats:italic>\n pathogenic variant at 32 sites in 10 countries; participants could then enroll in an open-label extension (OLE; completed August 2024).\n <\/jats:p>\n <\/jats:sec>\n \n Intervention and Exposure<\/jats:title>\n \n Adults with\n SOD1<\/jats:italic>\n -ALS were randomly assigned 2:1 to receive tofersen (100 mg) or placebo over a 24-week period in the VALOR study. All participants in the OLE were treated with tofersen.\n <\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Integrated analysis of VALOR and the OLE study aimed to compare early start vs placebo\/delayed start (approximately 6 months later) treatment with tofersen. Key efficacy end points included measures of axonal injury and neurodegeneration (neurofilament), function and strength, quality of life, and survival.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n VALOR enrolled 108 participants with 42 unique\n SOD1<\/jats:italic>\n pathogenic variants (mean [SD] age: placebo\/delayed-start group 51.2 [11.6] [n\u2009=\u200936]; early-start group: 48.1 [12.6] [n\u2009=\u200972]) with 19 (53%) and 43 (60%) of participants being male in the placebo\/delayed- and early-start groups, respectively. Overall, 95\/108 participants (88%) enrolled in the OLE, and 46 participants completed the OLE (early-start group, 34 [47%]; placebo\/delayed-start group, 12 [33%]). At OLE completion, participants could have accumulated 3.5 years or more (range, 192-276 weeks) of follow-up from the start of VALOR. Over 148 weeks, earlier initiation of tofersen (compared to later initiation) was associated with numerically less decline in measures of clinical function (Amyotrophic Lateral Sclerosis Functional Rating Scale\u2013Revised score, \u22129.9 vs \u221213.5 points), respiratory function (slow vital capacity, \u221213.8% vs \u221218.1%), muscle strength (handheld dynamometry megascore, \u22120.38 vs \u22120.43 points), and quality of life (Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 score, 17.0 vs 22.5 points; EuroQol 5 Dimension, 5 Level Questionnaire score, \u22120.1 vs \u22120.2 points). Tofersen prolonged survival relative to the expected natural history of\n SOD1<\/jats:italic>\n -ALS. Most adverse events were consistent with ALS progression or known procedural adverse effects. All serious neurological adverse events were reversible; few led to tofersen discontinuation.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n Final data from VALOR and the OLE demonstrated the benefit of tofersen in\n SOD1<\/jats:italic>\n -ALS and provide clear rationale for its use in this population.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier: VALOR\n NCT02623699<\/jats:ext-link>\n ; OLE\n NCT03070119<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaneurol.2025.4946","type":"journal-article","created":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T16:00:39Z","timestamp":1769443239000},"page":"115","source":"Crossref","is-referenced-by-count":47,"title":["Long-Term Tofersen in\n SOD1<\/i>\n Amyotrophic Lateral Sclerosis"],"prefix":"10.1001","volume":"83","author":[{"given":"Timothy M.","family":"Miller","sequence":"first","affiliation":[{"name":"Department of Neurology, Neuromuscular Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merit E.","family":"Cudkowicz","sequence":"additional","affiliation":[{"name":"Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela J.","family":"Shaw","sequence":"additional","affiliation":[{"name":"Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, United Kingdom"},{"name":"National Institute for Health and Care Research Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Genge","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gen","family":"Sobue","sequence":"additional","affiliation":[{"name":"Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan"},{"name":"Aichi Medical University, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Bucelli","sequence":"additional","affiliation":[{"name":"Department of Neurology, Neuromuscular Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriano","family":"Chi\u00f2","sequence":"additional","affiliation":[{"name":"Rita Levi Montalcini Department of Neurosciences, University of Turin, Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Van Damme","sequence":"additional","affiliation":[{"name":"University Hospitals Leuven, Leuven, Belgium"},{"name":"Neuroscience Department, Leuven Brain Institute, KU Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert C.","family":"Ludolph","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan D.","family":"Glass","sequence":"additional","affiliation":[{"name":"Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinsy A.","family":"Andrews","sequence":"additional","affiliation":[{"name":"Department of Neurology, NYU Langone, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suma","family":"Babu","sequence":"additional","affiliation":[{"name":"Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Benatar","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida"},{"name":"Amyotrophic Lateral Sclerosis Center, University of Miami Miller School of Medicine, Miami, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"McDermott","sequence":"additional","affiliation":[{"name":"Division of Neuroscience, School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Salachas","sequence":"additional","affiliation":[{"name":"Paris Amyotrophic Lateral Sclerosis Center, Department of Neurology, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Assistance Publique H\u00f4pitaux de Paris, Paris, 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