Sandra Vukusic, Florian Hubben, Antoine Gavoille, Yannis Malek, Olivier Casez, Laurent Kremer, Thomas Palpacuer, Romain Marignier, Françoise Durand-Dubief, Géraldine Androdias-Condemine, Julie Pique, Elisabeth Maillart, Patrick Vermersch, Jérôme de Seze
{"title":"除了切换到natalizumab的生物仿制药：改变JCV测试的影响是什么？","authors":"Sandra Vukusic, Florian Hubben, Antoine Gavoille, Yannis Malek, Olivier Casez, Laurent Kremer, Thomas Palpacuer, Romain Marignier, Françoise Durand-Dubief, Géraldine Androdias-Condemine, Julie Pique, Elisabeth Maillart, Patrick Vermersch, Jérôme de Seze","doi":"10.1177/13524585251322683","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The biosimilar drug of natalizumab was marketed with a new anti-John Cunningham virus (JCV) assay (Immunowell<sup>TM</sup>).</p><p><strong>Objectives: </strong>To compare the performance of the Immunowell<sup>TM</sup> JCV assay to Stratify<sup>TM</sup>, the reference one.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Two hundred and fifty-nine patients were included. Results were positive in 23.6% with Stratify<sup>TM</sup> and 61.4% with Immunowell<sup>TM</sup>. 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<sup>TM</sup>. According to index value cutoffs, 42.9% of the results showed discordances, with a systematic higher risk estimate for Immunowell<sup>TM</sup>. Most of them (83/111) were negative with Stratify<sup>TM</sup> and at low risk of progressive multifocal leukoencephalopathy (PML) (<0.8) with Immunowell<sup>TM</sup>. Eighteen were upgraded to intermediate risk (0.8-1.4) and 10 to high risk (⩾1.4).</p><p><strong>Conclusions: </strong>The Immunowell<sup>TM</sup> 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.</p>","PeriodicalId":520714,"journal":{"name":"Multiple sclerosis (Houndmills, Basingstoke, England)","volume":"31 7","pages":"877-881"},"PeriodicalIF":5.0000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Beyond the switch to the biosimilar of natalizumab: What is the impact of changing the JCV test?\",\"authors\":\"Sandra Vukusic, Florian Hubben, Antoine Gavoille, Yannis Malek, Olivier Casez, Laurent Kremer, Thomas Palpacuer, Romain Marignier, Françoise Durand-Dubief, Géraldine Androdias-Condemine, Julie Pique, Elisabeth Maillart, Patrick Vermersch, Jérôme de Seze\",\"doi\":\"10.1177/13524585251322683\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The biosimilar drug of natalizumab was marketed with a new anti-John Cunningham virus (JCV) assay (Immunowell<sup>TM</sup>).</p><p><strong>Objectives: </strong>To compare the performance of the Immunowell<sup>TM</sup> JCV assay to Stratify<sup>TM</sup>, the reference one.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Two hundred and fifty-nine patients were included. Results were positive in 23.6% with Stratify<sup>TM</sup> and 61.4% with Immunowell<sup>TM</sup>. 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<sup>TM</sup>. According to index value cutoffs, 42.9% of the results showed discordances, with a systematic higher risk estimate for Immunowell<sup>TM</sup>. Most of them (83/111) were negative with Stratify<sup>TM</sup> and at low risk of progressive multifocal leukoencephalopathy (PML) (<0.8) with Immunowell<sup>TM</sup>. Eighteen were upgraded to intermediate risk (0.8-1.4) and 10 to high risk (⩾1.4).</p><p><strong>Conclusions: </strong>The Immunowell<sup>TM</sup> 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.</p>\",\"PeriodicalId\":520714,\"journal\":{\"name\":\"Multiple sclerosis (Houndmills, Basingstoke, England)\",\"volume\":\"31 7\",\"pages\":\"877-881\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Multiple sclerosis (Houndmills, Basingstoke, England)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/13524585251322683\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/6/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple sclerosis (Houndmills, Basingstoke, England)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/13524585251322683","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/14 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Beyond the switch to the biosimilar of natalizumab: What is the impact of changing the JCV test?
Background: The biosimilar drug of natalizumab was marketed with a new anti-John Cunningham virus (JCV) assay (ImmunowellTM).
Objectives: To compare the performance of the ImmunowellTM JCV assay to StratifyTM, the reference one.
Methods: 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.
Results: Two hundred and fifty-nine patients were included. Results were positive in 23.6% with StratifyTM and 61.4% with ImmunowellTM. 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 ImmunowellTM. According to index value cutoffs, 42.9% of the results showed discordances, with a systematic higher risk estimate for ImmunowellTM. Most of them (83/111) were negative with StratifyTM and at low risk of progressive multifocal leukoencephalopathy (PML) (<0.8) with ImmunowellTM. Eighteen were upgraded to intermediate risk (0.8-1.4) and 10 to high risk (⩾1.4).
Conclusions: The ImmunowellTM 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.
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