Giulio Disanto, Sabine Schaedelin, Johanna Oechtering, Johannes Lorscheider, Riccardo Galbusera, Sebastian Finkener, Lutz Achtnichts, Patrice Lalive, Stefanie Müller, Caroline Pot, Robert Hoepner, Anke Salmen, Chiara Zecca, Lars G Hemkens, Marcus D'Souza, Bettina Fischer-Barnicol, Renaud Du Pasquier, Patrick Roth, Özgür Yaldizli, Maximilian Einsiedler, Tobias Derfuss, Ludwig Kappos, Claudio Gobbi, Cristina Granziera, Marjolaine Uginet, Aleksandra Maleska Maceski, Keltie McDonald, David Leppert, Pascal Benkert, Jens Kuhle
{"title":"瑞士多发性硬化症队列中开始B细胞消耗疗法的患者的治疗持久性和临床结果","authors":"Giulio Disanto, Sabine Schaedelin, Johanna Oechtering, Johannes Lorscheider, Riccardo Galbusera, Sebastian Finkener, Lutz Achtnichts, Patrice Lalive, Stefanie Müller, Caroline Pot, Robert Hoepner, Anke Salmen, Chiara Zecca, Lars G Hemkens, Marcus D'Souza, Bettina Fischer-Barnicol, Renaud Du Pasquier, Patrick Roth, Özgür Yaldizli, Maximilian Einsiedler, Tobias Derfuss, Ludwig Kappos, Claudio Gobbi, Cristina Granziera, Marjolaine Uginet, Aleksandra Maleska Maceski, Keltie McDonald, David Leppert, Pascal Benkert, Jens Kuhle","doi":"10.1177/20552173251315457","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Persistence to B cell depleting therapies (BCDT) like ocrelizumab and rituximab may be higher compared with other disease-modifying therapies (DMT) in multiple sclerosis (MS). Clinical trials directly comparing these treatments are lacking.</p><p><strong>Objective: </strong>To compare the risk of treatment discontinuation, relapse, and confirmed disability worsening in patients starting BCDT vs other DMT within real-world settings.</p><p><strong>Methods: </strong>In a longitudinal cohort study, patients with relapsing MS starting BCDT (ocrelizumab/rituximab, <i>n</i> = 269) after enrolment into the Swiss MS Cohort (SMSC) were evaluated for treatment discontinuation, occurrence of relapses, and disability worsening in comparison with platform (<i>n</i> = 57) and oral (<i>n</i> = 454) DMT, or natalizumab (<i>n</i> = 73) using Cox regression with double robust adjustment for baseline covariates.</p><p><strong>Results: </strong>Patients starting BCDT were less likely to discontinue treatment than all other DMT combined (HR = 0.26, 95% CI = 0.18-0.36, <i>p</i> < .01), oral DMT (HR = 0.28, 95% CI = 0.20-0.39, <i>p</i> < .01) and natalizumab (HR = 0.35, 95% CI = 0.21-0.58, <i>p</i> < .01). BCDT were associated with lower risk of relapses as compared to oral DMT HR = 0.59, 95% CI = 0.39-0.88, <i>p</i> < .01), but not to natalizumab (HR = 0.90, 95% CI = 0.45-1.82, <i>p</i> = .778). Disability worsening was not significantly different between treatment groups.</p><p><strong>Conclusion: </strong>We provide real-world evidence for patients being more persistent to BCDT than to other treatments, and better clinical outcomes may partly explain this.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":"11 1","pages":"20552173251315457"},"PeriodicalIF":2.5000,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866361/pdf/","citationCount":"0","resultStr":"{\"title\":\"Treatment persistence and clinical outcomes in patients starting B cell depleting therapies within the Swiss MS Cohort.\",\"authors\":\"Giulio Disanto, Sabine Schaedelin, Johanna Oechtering, Johannes Lorscheider, Riccardo Galbusera, Sebastian Finkener, Lutz Achtnichts, Patrice Lalive, Stefanie Müller, Caroline Pot, Robert Hoepner, Anke Salmen, Chiara Zecca, Lars G Hemkens, Marcus D'Souza, Bettina Fischer-Barnicol, Renaud Du Pasquier, Patrick Roth, Özgür Yaldizli, Maximilian Einsiedler, Tobias Derfuss, Ludwig Kappos, Claudio Gobbi, Cristina Granziera, Marjolaine Uginet, Aleksandra Maleska Maceski, Keltie McDonald, David Leppert, Pascal Benkert, Jens Kuhle\",\"doi\":\"10.1177/20552173251315457\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Persistence to B cell depleting therapies (BCDT) like ocrelizumab and rituximab may be higher compared with other disease-modifying therapies (DMT) in multiple sclerosis (MS). Clinical trials directly comparing these treatments are lacking.</p><p><strong>Objective: </strong>To compare the risk of treatment discontinuation, relapse, and confirmed disability worsening in patients starting BCDT vs other DMT within real-world settings.</p><p><strong>Methods: </strong>In a longitudinal cohort study, patients with relapsing MS starting BCDT (ocrelizumab/rituximab, <i>n</i> = 269) after enrolment into the Swiss MS Cohort (SMSC) were evaluated for treatment discontinuation, occurrence of relapses, and disability worsening in comparison with platform (<i>n</i> = 57) and oral (<i>n</i> = 454) DMT, or natalizumab (<i>n</i> = 73) using Cox regression with double robust adjustment for baseline covariates.</p><p><strong>Results: </strong>Patients starting BCDT were less likely to discontinue treatment than all other DMT combined (HR = 0.26, 95% CI = 0.18-0.36, <i>p</i> < .01), oral DMT (HR = 0.28, 95% CI = 0.20-0.39, <i>p</i> < .01) and natalizumab (HR = 0.35, 95% CI = 0.21-0.58, <i>p</i> < .01). BCDT were associated with lower risk of relapses as compared to oral DMT HR = 0.59, 95% CI = 0.39-0.88, <i>p</i> < .01), but not to natalizumab (HR = 0.90, 95% CI = 0.45-1.82, <i>p</i> = .778). Disability worsening was not significantly different between treatment groups.</p><p><strong>Conclusion: </strong>We provide real-world evidence for patients being more persistent to BCDT than to other treatments, and better clinical outcomes may partly explain this.</p>\",\"PeriodicalId\":18961,\"journal\":{\"name\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"volume\":\"11 1\",\"pages\":\"20552173251315457\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-02-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866361/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20552173251315457\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20552173251315457","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:与其他疾病改善疗法(DMT)相比,在多发性硬化症(MS)中,B细胞消耗疗法(BCDT)如ocrelizumab和rituximab的持久性可能更高。目前还缺乏直接比较这些治疗方法的临床试验。目的:比较现实环境中开始BCDT和其他DMT的患者停药、复发和确认残疾恶化的风险。方法:在一项纵向队列研究中,加入瑞士MS队列(SMSC)的复发性MS患者开始使用BCDT (ocrelizumab/rituximab, n = 269),与平台(n = 57)和口服(n = 454) DMT或natalizumab (n = 73)相比,使用Cox回归评估治疗中断、复发发生和残疾恶化情况。结果:开始BCDT治疗的患者停止治疗的可能性低于所有其他DMT联合治疗(HR = 0.26, 95% CI = 0.18-0.36, p p p p = .778)。治疗组间残疾恶化无显著差异。结论:我们提供了BCDT患者比其他治疗更持久的现实证据,更好的临床结果可能部分解释了这一点。
Treatment persistence and clinical outcomes in patients starting B cell depleting therapies within the Swiss MS Cohort.
Background: Persistence to B cell depleting therapies (BCDT) like ocrelizumab and rituximab may be higher compared with other disease-modifying therapies (DMT) in multiple sclerosis (MS). Clinical trials directly comparing these treatments are lacking.
Objective: To compare the risk of treatment discontinuation, relapse, and confirmed disability worsening in patients starting BCDT vs other DMT within real-world settings.
Methods: In a longitudinal cohort study, patients with relapsing MS starting BCDT (ocrelizumab/rituximab, n = 269) after enrolment into the Swiss MS Cohort (SMSC) were evaluated for treatment discontinuation, occurrence of relapses, and disability worsening in comparison with platform (n = 57) and oral (n = 454) DMT, or natalizumab (n = 73) using Cox regression with double robust adjustment for baseline covariates.
Results: Patients starting BCDT were less likely to discontinue treatment than all other DMT combined (HR = 0.26, 95% CI = 0.18-0.36, p < .01), oral DMT (HR = 0.28, 95% CI = 0.20-0.39, p < .01) and natalizumab (HR = 0.35, 95% CI = 0.21-0.58, p < .01). BCDT were associated with lower risk of relapses as compared to oral DMT HR = 0.59, 95% CI = 0.39-0.88, p < .01), but not to natalizumab (HR = 0.90, 95% CI = 0.45-1.82, p = .778). Disability worsening was not significantly different between treatment groups.
Conclusion: We provide real-world evidence for patients being more persistent to BCDT than to other treatments, and better clinical outcomes may partly explain this.