M N Zakharova, T O Simaniv, K V Sapozhnikov, D G Tolkacheva, V D Sokolova, N A Sableva, O N Mironenko, A A Lazarev, T V Khimich
{"title":"[在俄罗斯联邦,比较地沃齐尼单抗和二线治疗复发缓解型多发性硬化症的疗效:系统综述和网络荟萃分析]。","authors":"M N Zakharova, T O Simaniv, K V Sapozhnikov, D G Tolkacheva, V D Sokolova, N A Sableva, O N Mironenko, A A Lazarev, T V Khimich","doi":"10.17116/jnevro202512502158","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To compare efficacy of the new drug divozilimab with other second-line treatment options for relapsing remitting multiple sclerosis (RRMS) that have been already included or submitted application to be included into the «14 high-cost nosologies» program in the Russian Federation.</p><p><strong>Material and methods: </strong>We conducted systematic literature review (PROSPERO ID CRD42022310082) and frequentist network meta-analysis of 2-years efficacy of divozilimab and other second-line therapies to treat RRMS.</p><p><strong>Results: </strong>Annualized relapse rate ratio in divozilimab vs fingolimod was 0.4 (95% CI 0.3-0.7), divozilimab vs cladribin 0.5 (95% CI 0.3-0.9), divozilimab vs alemtuzumab 0.7 (95% CI 0.3-1.7), divozilimab vs ocrelizumab 0.7 (95% CI 0.3-1.6), divozilimab vs ofatumumab 0.7 (95% CI 0.4-1.1), divozilimab vs natalizumab 0.4 (95% CI 0.4-1.1) respectively. Divozilimab had the highest SUCRA rank (0.9) while fingolimod had the lowest (0.4).</p><p><strong>Conclusion: </strong>Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment.</p>","PeriodicalId":56370,"journal":{"name":"Zhurnal Nevrologii I Psikhiatrii Imeni S S Korsakova","volume":"125 2","pages":"58-68"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Comparing the efficacy of divozilimab and second-line treatments for relapsing-remitting multiple sclerosis in the Russian Federation: a systematic review and network meta-analysis].\",\"authors\":\"M N Zakharova, T O Simaniv, K V Sapozhnikov, D G Tolkacheva, V D Sokolova, N A Sableva, O N Mironenko, A A Lazarev, T V Khimich\",\"doi\":\"10.17116/jnevro202512502158\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To compare efficacy of the new drug divozilimab with other second-line treatment options for relapsing remitting multiple sclerosis (RRMS) that have been already included or submitted application to be included into the «14 high-cost nosologies» program in the Russian Federation.</p><p><strong>Material and methods: </strong>We conducted systematic literature review (PROSPERO ID CRD42022310082) and frequentist network meta-analysis of 2-years efficacy of divozilimab and other second-line therapies to treat RRMS.</p><p><strong>Results: </strong>Annualized relapse rate ratio in divozilimab vs fingolimod was 0.4 (95% CI 0.3-0.7), divozilimab vs cladribin 0.5 (95% CI 0.3-0.9), divozilimab vs alemtuzumab 0.7 (95% CI 0.3-1.7), divozilimab vs ocrelizumab 0.7 (95% CI 0.3-1.6), divozilimab vs ofatumumab 0.7 (95% CI 0.4-1.1), divozilimab vs natalizumab 0.4 (95% CI 0.4-1.1) respectively. Divozilimab had the highest SUCRA rank (0.9) while fingolimod had the lowest (0.4).</p><p><strong>Conclusion: </strong>Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment.</p>\",\"PeriodicalId\":56370,\"journal\":{\"name\":\"Zhurnal Nevrologii I Psikhiatrii Imeni S S Korsakova\",\"volume\":\"125 2\",\"pages\":\"58-68\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Zhurnal Nevrologii I Psikhiatrii Imeni S S Korsakova\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17116/jnevro202512502158\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Zhurnal Nevrologii I Psikhiatrii Imeni S S Korsakova","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17116/jnevro202512502158","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
目的:比较新药divozilimab与其他二线治疗方案治疗复发缓解型多发性硬化症(RRMS)的疗效,这些方案已被纳入或已提交申请纳入俄罗斯联邦“14种高成本疾病”项目。材料和方法:我们进行了系统的文献综述(PROSPERO ID CRD42022310082)和频率网络荟萃分析,对地沃齐利单抗和其他二线疗法治疗RRMS的2年疗效进行了分析。结果:divozilimab vs fingolimod的年复发率分别为0.4 (95% CI 0.3-0.7), divozilimab vs cladribin 0.5 (95% CI 0.3-0.9), divozilimab vs alemtuzumab 0.7 (95% CI 0.3-1.7), divozilimab vs ocrelizumab 0.7 (95% CI 0.3-1.6), divozilimab vs ofatumumab 0.7 (95% CI 0.4-1.1), divozilimab vs natalizumab 0.4 (95% CI 0.4-1.1)。Divozilimab的SUCRA排名最高(0.9),而fingolimod的最低(0.4)。结论:系统文献回顾和网络荟萃分析显示,地伐齐单抗治疗2年的年复发率与阿仑单抗、奥克雷单抗、奥伐单抗、那他单抗治疗的年复发率差异无统计学意义。
[Comparing the efficacy of divozilimab and second-line treatments for relapsing-remitting multiple sclerosis in the Russian Federation: a systematic review and network meta-analysis].
Objective: To compare efficacy of the new drug divozilimab with other second-line treatment options for relapsing remitting multiple sclerosis (RRMS) that have been already included or submitted application to be included into the «14 high-cost nosologies» program in the Russian Federation.
Material and methods: We conducted systematic literature review (PROSPERO ID CRD42022310082) and frequentist network meta-analysis of 2-years efficacy of divozilimab and other second-line therapies to treat RRMS.
Results: Annualized relapse rate ratio in divozilimab vs fingolimod was 0.4 (95% CI 0.3-0.7), divozilimab vs cladribin 0.5 (95% CI 0.3-0.9), divozilimab vs alemtuzumab 0.7 (95% CI 0.3-1.7), divozilimab vs ocrelizumab 0.7 (95% CI 0.3-1.6), divozilimab vs ofatumumab 0.7 (95% CI 0.4-1.1), divozilimab vs natalizumab 0.4 (95% CI 0.4-1.1) respectively. Divozilimab had the highest SUCRA rank (0.9) while fingolimod had the lowest (0.4).
Conclusion: Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment.
期刊介绍:
Одно из старейших медицинских изданий России, основанное в 1901 году. Создание журнала связано с именами выдающихся деятелей отечественной медицины, вошедших в историю мировой психиатрии и неврологии, – С.С. Корсакова и А.Я. Кожевникова.
Широкий диапазон предлагаемых журналом материалов и разнообразие форм их представления привлекают внимание научных работников и врачей, опытных и начинающих медиков, причем не только неврологов и психиатров, но и специалистов смежных областей медицины.