{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T23:23:16Z","timestamp":1785367396264,"version":"3.55.0"},"reference-count":8,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"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":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      The biosimilar drug of natalizumab was marketed with a new anti-John Cunningham virus (JCV) assay (Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>\n                      To compare the performance of the Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      JCV assay to Stratify\n                      <jats:sup>TM<\/jats:sup>\n                      , the reference one.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We analyzed retrospectively serological results from patients with multiple sclerosis (MS) followed in four French MS centers and tested simultaneously in routine with both tests.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Two hundred and fifty-nine patients were included. Results were positive in 23.6% with Stratify\n                      <jats:sup>TM<\/jats:sup>\n                      and 61.4% with Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      . A binary discordance was found in 37.8%. Sensitivity and negative predictive value were 100%, with lower specificity (50.5%) and positive predictive value (38.4%) for Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      . According to index value cutoffs, 42.9% of the results showed discordances, with a systematic higher risk estimate for Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      . Most of them (83\/111) were negative with Stratify\n                      <jats:sup>TM<\/jats:sup>\n                      and at low risk of progressive multifocal leukoencephalopathy (PML) (&lt;0.8) with Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      . Eighteen were upgraded to intermediate risk (0.8\u20131.4) and 10 to high risk (\u2a7e1.4).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      The Immunowell\n                      <jats:sup>TM<\/jats:sup>\n                      JCV IgG assay is reliable to detect patients at risk of progressive multifocal leukoencephalopathy, but the high rate of discrepancy is challenging in deciding to continue on natalizumab or not.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251322683","type":"journal-article","created":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T08:30:47Z","timestamp":1749889847000},"page":"877-881","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Beyond the switch to the biosimilar of natalizumab: What is the impact of changing the JCV test?"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7337-7122","authenticated-orcid":false,"given":"Sandra","family":"Vukusic","sequence":"first","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Universit\u00e9 de Lyon, Universit\u00e9 Claude Bernard Lyon 1, Lyon, France"},{"name":"Observatoire Fran\u00e7ais de la Scl\u00e9rose en Plaques, Centre de Recherche en Neurosciences de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Hubben","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Universit\u00e9 de Lyon, Universit\u00e9 Claude Bernard Lyon 1, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9118-0849","authenticated-orcid":false,"given":"Antoine","family":"Gavoille","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Universit\u00e9 de Lyon, Universit\u00e9 Lyon 1, CNRS, Laboratoire de Biom\u00e9trie et Biologie \u00c9volutive, Villeurbanne, France"},{"name":"Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannis","family":"Malek","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Universit\u00e9 de Lyon, Universit\u00e9 Claude Bernard Lyon 1, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Casez","sequence":"additional","affiliation":[{"name":"Neurologie, Pathologies Inflammatoires du Syst\u00e8me Nerveux, CRCSEP Grenoble, CHU Grenoble Alpes, Grenoble, France"},{"name":"TIMC, T-RAIG (Translational Research in Autoimmunity and Inflammation Group), Universit\u00e9 Grenoble Alpes, Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Kremer","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Investigation Center, CHU de Strasbourg, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Palpacuer","sequence":"additional","affiliation":[{"name":"Service de neurologie, Centre Hospitalier R\u00e9gional Mulhouse Sud Alsace, Mulhouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5967-2800","authenticated-orcid":false,"given":"Romain","family":"Marignier","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lyon, Universit\u00e9 Claude Bernard Lyon 1, Lyon, France"},{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Hospices Civils de Lyon, H\u00f4pital Neurologique Pierre Wertheimer, Centre de R\u00e9f\u00e9rence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Bron, France"},{"name":"Centre de Recherche en Neurosciences de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7oise","family":"Durand-Dubief","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00e9raldine","family":"Androdias-Condemine","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Pique","sequence":"additional","affiliation":[{"name":"Service de Neurologie, scl\u00e9rose en plaques, pathologies de la my\u00e9line et neuro-inflammation, Hospices Civils de Lyon, Bron, France"},{"name":"Hospices Civils de Lyon, H\u00f4pital Neurologique Pierre Wertheimer, Centre de R\u00e9f\u00e9rence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7699-0328","authenticated-orcid":false,"given":"Elisabeth","family":"Maillart","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Center, Department of Neurology, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, AP-HP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Vermersch","sequence":"additional","affiliation":[{"name":"Univ. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9r\u00f4me","family":"de Seze","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Investigation Center, CHU de Strasbourg, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,6,14]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1080\/14712598.2023.2290530"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.5007"},{"key":"e_1_3_2_4_2","unstructured":"European Medicines Agency https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/tyruko-epar-public-assessment-report_en.pdf"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.22128"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30282-X"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2019.2670"},{"key":"e_1_3_2_8_2","first-page":"1228","article-title":"A new assay for detection of anti-JCV antibodies to support risk stratification and monitoring for progressive multifocal leukoencephalopathy in patients considering or in treatment with natalizumab","volume":"30","author":"Adler F","year":"2024","unstructured":"Adler F, Anderson M, Bartl T, et al. A new assay for detection of anti-JCV antibodies to support risk stratification and monitoring for progressive multifocal leukoencephalopathy in patients considering or in treatment with natalizumab. Mult Scler J 2024; 30: 1228\u20131229.","journal-title":"Mult Scler J"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/13524585241300972"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251322683","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13524585251322683","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251322683","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T04:17:50Z","timestamp":1777695470000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13524585251322683"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":8,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1177\/13524585251322683"],"URL":"https:\/\/doi.org\/10.1177\/13524585251322683","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]}}}